OBR Daily Commentary

forumImage

forum comments

Read Article arrow

H. Jack West, MD (Posted: July 08, 2020)

quotes

The benefit of low dose chest CT screening for lung cancer remains somewhat controversial, but this liberalization would allow better detection of patients with lung cancer who fall below the radar for current screening.

quotes

Reply

Howard S. Hochster, MD (Posted: July 08, 2020)

quotes

While a "complete response" is great for our patients, the Complete Response Letter was less auspicious for the sponsors. The FDA turned down the application for approval which was based on a 100 patient uncontrolled study, especially in light of the IMBrave 150 randomized, global phase 3 with atezo-bev.
Thanks to the FDA for maintaining some standards requiring controlled trials!!
Especially since 30% of patients went off study for AEs. Fortunately, the phase 3 LEAP-002 is underway and should provide specific data on the benefit of adding anti-PD1 to lenvatinib. We look forward to those data.

quotes

Reply

Howard S. Hochster, MD (Posted: June 19, 2020)

quotes

Another, but far more problematic approval for Pembro. Which tumors actually have high TMB but not MSI-H? Out of 750+ screened, 102 fit this category for mutations of > 10 mut/MB but only 70 if the cutoff is 13. For the 102, most of the tumors were SCLC, followed by cervix, endometrial and anal cancer. These basically had about a 30% RR but many of these would receive anti-PD1 anyway. It would be useful to know how many of these are hypermutated tumors due to POLE and similar mutations. All in all, this is likely to be a very rare happening in any tumor where we aren't already using anti-PD1 as SOC.

quotes

Reply

Dean Gesme, MD (Posted: June 18, 2020)

quotes

The positive primary endpoint of improved iDFS with Abemaciclib plus adjuvant AI in this Monarch E interim evaluation stands in confusingly stark contrast to the negative efficacy reported from the preliminary PALLUS for adjuvant high risk early stage breast cancer! Could this be due to genuine differences in efficacy, differences in the study populations, or just statistical flukes in the data?

quotes

Reply

H. Jack West, MD (Posted: June 16, 2020)

quotes

We await phase 3 data, but many will welcome a new option with an approximately 35% response rate in phase 2 work to this point. Relapsed small cell lung cancer is a clinical setting in which the FDA-approved standard of care, topotecan, is not widely embraced, due to its significant hematologic toxicity and requirement for 5 days of IV therapy each cycle. The cost of lurbinectedin should lead oncologists to expect to be impressed by phase III data, and many may wait for more data before prescribing it. There is also rather low awareness of lurbinectedin in the broad oncology community and even limited awareness among many thoracic oncologists.

quotes

Reply

Thomas Marsland, MD (Posted: June 16, 2020)

quotes

I actually enjoyed the experience. I certainly missed mingling with friends and colleagues. Also missed the Chicago experience. However as an educational experience, I felt it more than met my needs. I was able to "attend" the presentations I wanted and didn't have to run through crowded halls to make a lecture and miss others I wanted to hear that happened to be scheduled at the same time. I was able to hear the presentations and see the slides in the comfort of my own home (also while enjoying a fine red wine...) I hope we are all back together in person in Chicago but I think ASCO did a really good job with this meeting in a relatively short time frame. Kudos.

quotes

Reply

William McGivney, PhD (Posted: June 11, 2020)

quotes

This comment relates to the article described by Mariotto et al that projects that
“Based solely on population changes due to aging and growth, the researchers estimate that the national costs for cancer-related medical care and oral prescription drugs in 2030 will be $221 billion and $25 billion, respectively, totaling nearly $246 billion. This represents a total increase in national cost of 34 percent.”
Quite frankly, a 34% increase in terms of increase over a 15-year period seemed somewhat tame. It is understood that the projection is based “solely” on population changes.
I found a similar analysis done by the same group and published in 2011 in JNCI. This article by Mariotto et al estimated that for the period 2010 through 2020, with a constant incidence and survival and costs of care, Cancer-attributable medical costs would rise by 27%. Again, the 27% percent increase in the total medical costs “reflects growth and aging in the population only”.
In this 2011 article, a sensitivity analysis was applied to evaluate the impact of advancing technology (e.g., testing, biologics) and projected that with a 5% annual increase in costs of care, Cancer attributable medical costs would increase by 66% from 2010 to 2020. As such, the application of reasonable “costs of cancer care” factor by the authors is necessary to arrive at a more robust estimation of what can be expected in terms of total increase in the national Cancer-attributable medical costs across defined periods of time.

quotes

Reply

H. Jack West, MD (Posted: June 05, 2020)

quotes

This is a provocative retrospective analysis of outcomes for patients who received stereotactic radiosurgery (SRS) for brain metastasis in the setting of small cell lung cancer compared to whole brain radiation therapy (WBRT), demonstrating numerically superior results with SRS — not statistically significant and potentially explained by selection biases in a retrospective study — but clearly not worse with SRS compared to WBRT. Considering the toxicity concerns with WBRT, I definitely consider SRS to be a very viable option to consider and arguably favor in patients with a limited number of brain metastases from SCLC.

quotes

Reply

Thomas Marsland, MD (Posted: June 04, 2020)

quotes

As a Conquer Cancer board member I am extremely proud of our support for cutting edge research. I am reaching out to ask your support in these efforts. It is only with the generosity of our donors that we can continue this mission. CC provides the best ROI for your philanthropic dollars. We support research in all cancers; at all stages from prevention, to diagnosis to treatment and supportive care. And we do it globally. So Please consider CC when you are making your charitable donations. Thx, Tom.

quotes

Reply

Debu Tripathy, MD (Posted: June 01, 2020)

quotes

The interim analysis of the very large PALLAS trial testing the addition of 2 years of palbociclib to standard adjuvant endocrine therapy is truly a disappointment not only as negative trial, but as a rejection of the conceptual framework – that a drug known to double progression-free survival in the metastatic setting has no impact in the adjuvant setting. These results will force us to re-evaluate the fundamental biology of micrometastatic disease, in some cases dormant cells that lie in hiding without even dividing for years, that for unknown reasons can reawaken and cause clinical recurrence. Anti-proliferative drugs may not be the answer, and a better understanding of dormancy will be critical. Finally, it remains possible that longer duration of therapy, or one of the other two cyclin-dependent kinase 4/6 inhibitors (both of which are being tested) could yield a positive result.

quotes

Reply

Jack West (Posted: May 30, 2020)

quotes

This is a regimen that hasn't demonstrated a survival benefit. I would expect that it should achieve very little traction in such a crowded therapeutic landscape.

quotes

Reply

Dean Gesme (Posted: May 30, 2020)

quotes

Disappointing that adding palbociclib to Standard adjuvant aromatase inhibitor therapy for Stage II & III hormone receptor positive breast cancer failed to improve overall outcomes in this study. Adjuvant studies with ribociclib and abemociclib are awaited but this outcome from PALLAS dampens the prospects for major clinical benefits.

quotes

Reply

Howard Hochster (Posted: May 30, 2020)

quotes

Great news for HCC patients. In the ImBRAVE150 study Child-Pugh Class A patients were randomized to Atezo-Bev vs Sorafenib. The IO combination showed improved PFS, toxicity and QoL. A real step forward for patients with HCC, not amenable to surgery or TACE.

quotes

Reply

H. Jack West, MD (Posted: May 28, 2020)

quotes

Another positive trial against chemo alone, this regimen that is just approved ahead of presentation of the data at ASCO 2020 will face the same challenge as nivo/ipi alone based on CheckMate-227: a positive result and another option, but one for which I know no lung cancer specialist who would favor ranking either of these ahead of chemo/pembro for most patients, or possibly pembro monotherapy for patients with high PD-L1 -- at least without further evidence to support the concept that a nivo/ipi based regimen with or without 2 cycles of chemo is incrementally BETTER than what we already have.

I strongly suspect that both of these options will be fiercely marketed but destined to achieve <10% of the market share, even for the total of CM-227 & CM-9LA based treatments. We're looking for something better than our 2019/2020 standards, not better than our 2016 standard of care.

quotes

Reply

Victoria Villaflor (Posted: May 26, 2020)

quotes

This is truly a sad day when we let politics get in the way of science. The studies done to date are in ill patients who were hospitalized and at greater risk of death, this article comments on the ethics of doing a study which evaluates the question in patients who are at home and hence, healthier. As a scientist and physician, what I would like to know is the following:
1.) Time to clear virus
2.) Recovery time from symptoms
3.) number of hospitalizations
4.) Number of patients requiring ventilator support
5.) Number of deaths in each group.
Hydroxychloraquine is a safe drug not only have many of my patients taken it for lupus and other autoimmune diseases, I have taken it as malaria prophylaxis. Scientifically, by reduction of inflammation may reduce risk of ARDS due to cytokine storm. I am a non-partisan person and don't care one way or another about politics. To allow this type of garbage into our scientific rigors truly marks a sad day! It appears as this drug is being judged based on ones like or dislike for the president. Stop this childish rhetoric and let the science speak for itself.

quotes

Reply

H. Jack West, MD (Posted: May 26, 2020)

quotes

Another option in the first line setting for patients with advanced ALK+ NSCLC, though brigatinib ended up with overall survival results that appear no better and even numerically inferior to what we've seen with alectinib. Accordingly, I don't think there's reason to expect brigatinib should displace alectinib as the prevailing favored standard of care in this setting.

quotes

Reply

H. Jack West, MD (Posted: May 24, 2020)

quotes

Elderly or frail patients did just as well on a reduced dose of erlotinib, with fewer adverse effects. Nice to have some prospective data on a question we've been asking and sometimes empirically managing differently based on our inferences for over a decade.

quotes

Reply

H. Jack West, MD (Posted: May 21, 2020)

quotes

While it's always nice to have another option, it's hard for me to see how atezolizumab provides any advantage over pembrolizumab in what is a nearly identical clinical setting. Oncologists have been happy using pembro monotherapy for patients with tumors demonstrating high tumor PD-L1 expression (50% or greater) since late 2016, and now there is a newly approved dose and schedule for pembro every 6 weeks. I don't see any group or setting in which atezo monotherapy is a better option.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: May 21, 2020)

quotes

PAPR inhibitor approval means that we will need to genotype all advanced prostate cancer patients. With about 20% of patients potentially benefiting, the era of precision oncology is upon us.

quotes

Reply

H. Jack West, MD (Posted: May 18, 2020)

quotes

Good to see another contender for the molecularly defined population that has yet to claim a highly effective and well tolerated targeted therapy. Amivantamab has a fairly encouraging response rate and disease control rate and what appears at first glance to be a more manageable side effect profile than some of the other contenders here. Await more information from the upcoming ASCO data.

quotes

Reply

H. Jack West, MD (Posted: May 18, 2020)

quotes

I imagine that the nivolumab/ipilumumab combination will have some appeal to patients or physicians who strongly value having a non-chemotherapy regimen for the broader population of patients and not just the proportion with high tumor PD-L1 (yes, pembro is approved for patients with tumors showing PD-L1 expression 1-49%, but that's just because of trial gamesmanship keeping the KEYNOTE-042 trial positive despite the dilution of the high PD-L1 population with patients with low PD-L1 who drag down the results).

Importantly, however, the benefit of nivolumab/ipilumumab is over a chemotherapy arm in the CheckMate-227 trial, so this is not clearly better than the actual current standard of care of chemo/pembro for most patients, or pembro monotherapy for those with tumors showing high tumor PD-L1 expression.

In addition, the chemo-free nivo/ipi regimen doesn't have less toxicity than chemotherapy -- it's overall pretty comparable in side effects, though those with immunotherapy are less predictable than with chemotherapy.

I think most thoracic oncologists will consider the nivo/ipi regimen to be an option that has a very limited role, if any, next to the contemporary alternatives we're already using.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: May 14, 2020)

quotes

We expect to see overall survival results from several agents in non-metastatic castration resistant prostate cancer. I will be discussing these presentations at the ASCO meeting in a presentation entitled "Advanced Prostate Cancer: Putting Survival Into Perspective". I look forward to offering my commentary at the meeting.

quotes

Reply

H. Jack West, MD (Posted: May 13, 2020)

quotes

Results are as encouraging as expected for a combination that we already know works in metastatic disease. I personally don't consider it an amazing accomplishment to have 26 of 30 patients who were already felt to be candidates for surgery go on to get surgery after treatment that is already routine in other settings.

The concept is promising enough, but small phase II data here add very little. These results can't be compared to any standard expectations in a large population, and the only way to really assess the utility of this approach is a prospective randomized trial against standard treatment. These results should change management for nobody.

quotes

Reply

H. Jack West, MD (Posted: May 12, 2020)

quotes

A very effective drug, but without any advantage over selpercatinib, so a challenging situation in which these two competitors will split a narrow clinical setting in a marketing catfight in which I think it will be difficult to capture clinician attention when most will see perhaps a single RET fusion+ candidate every 2-3 years.

quotes

Reply

H. Jack West, MD (Posted: May 11, 2020)

quotes

Just a few days ago I added very favorable comments about capmatinib being approved for MET exon 14 mutation-positive NSCLC, which is a critically valuable treatment for that small population, and I would echo the same appreciation for the FDA approval of selpercatinib for patients with RET fusion-positive advanced NSCLC. This therapy is very compelling as a first line treatment, given its favorable extracranial as well as intracranial efficacy alongside very favorable toxicity. if not first line, it is certainly an agent that should be administered as soon as feasible after that.

Both approvals are for populations that represent a 2-4% molecularly selected population in NSCLC. These targets are on top of EGFR, ALK, ROS1, BRAF V600E, and TRK, making it far more sensible to make broad NGS-based molecular testing the optimal testing strategy for initial workup, given the number of tests that have remarkably valuable targeted therapies available. Just sending selectively for EGFR, ALK, +/- ROS1 misses the opportunity to identify what are now far too many critical targets to miss.

quotes

Reply

H. Jack West, MD (Posted: May 07, 2020)

quotes

Though the MET exon 14 population is a small group of NSCLC (2-4%), capmatinib is highly effective and very well tolerated. In my opinion, it should be considered along EGFR, ALK, ROS1 as a target with a therapy effective enough to have the associated treatment be favored first line, or at the very least be employed at some point for every patient. It should make testing for MET mutations in the context of next generation sequencing a standard of care, particularly as we are now at a point where there are so many targeted therapies for uncommon targets that we should be doing broad multigene testing rather than individual tests. It doesn't make sense to do individual tests for more than 4-5 targets at a time. Capmatinib for MET exon 14 mutations is too effective to miss the opportunity for these patients.

quotes

Reply

William McGivney, PhD (Posted: May 05, 2020)

quotes

ICER steps in to take advantage of “informing the public debate” (I did not know we were there yet) regarding pricing for remdesivir. Clearly, the presentation of pricing models for remdesivir also affords enhanced visibility for ICER in addition to being first in “informing the public debate”. With all such analyses, the societal ravages of this pandemic in the United States must be fully considered as well as the suffering experienced by individual symptomatic patients and their caregivers. Also, before I weigh in, it must be recognized that Gilead has pledged to provide 1.5 million doses of remdesivir for compassionate use, expanded use, and clinical trials.
ICER proposes a model of cost recovery that recommends $10 per 10-day dosing course. The cost recovery model arrives at this pricing recommendation after including production costs such as active pharmaceutical ingredients, costs of excipients, packaging and a small profit margin (definitely sounds small does it not?). The costs of R and D were set to “zero” given that research on remdesivir in hepatitis C was included in a “suite of agents” with some agents already successfully launched and marketed for hepatitis C.
Huh? Are we not talking about COVID-19, the disease caused by this new coronavirus. Huang et al way back in 2005 in J of Gastroenterology and Hepatology discuss the similarities between the hepatitis C virus and the “novel coronavirus SARS CoV”. Similarities include single strand RNA viruses, elevated blood IL-8, etc. The COVID-19 virus then differs from the SARS CoV in important ways. Clearly, anyone indicating that research on Hep C patients can be applied directly to define the safety and efficacy of the treatment of COVID-19 would be laughed, if not driven out of any reputable scientific/clinical meeting. Regardless we are at an ICER-recommended price of $10 for a 10-day course of remdesivir for COVID-19.
The ICER Cost-effectiveness model proposes $4500 as a high-end appropriate price for a 10-day treatment. The model captures QOL improvements, mortality benefits (undefined as yet), fewer hospital and ICU days. Given a general hospital treatment reduction from a stay of 15 days to a stay of 11 days (per the NIAID initial study results) what would the per patient cost-savings be for that; never mind the benefit to patient clinical outcomes. Someone else please do the calculation. ICER advances its recommendations acknowledging the “great clinical evidence uncertainty”.
So, at $10 per patient per one million patients, we would spend $10 million and at $4500 per patient for 1 million patients we would spend $4.5 billion. Given the potential impacts on individual patient health, societal public health, and the nation’s economy, we will need others to participate in the coming public debate.

quotes

Reply

Thomas Marsland, MD (Posted: May 05, 2020)

quotes

The increase in compensation for pure telephone visits is appreciated. The actual time and work for a phone discussion is really not very different than that for a video meeting. Chart review, conducting the interview, documentation and arranging follow up care is really the same. As I have said before, many of my older, less affluent patients do not have the skills or resources needed for a "video" visit. The question remains as to how the payer community will deal with these issue in the future once we have passed the current pandemic problems ( probably not for a while...)?

quotes

Reply

Fred J. Pane (Posted: May 01, 2020)

quotes

I find the study interesting. If I was enrolling a patient in a clinical trial, I would be looking at whether or not the patient has the means to cover all the needed support care, etc. before enrolling them and to determine if what is being asked in the trial, goes beyond what care we would have provided in a non-clinical trial/standard of care and whether or not that supportive care would have been reimbursed/offered in the standard of care. In a way, the patients would be treatment failures in the study and could skew the metrics being measured in the clinical trial?

quotes

Reply

H. Jack West, MD (Posted: April 29, 2020)

quotes

An important, extremely welcome option, particularly in the setting of potential coronavirus exposure and the value of minimizing visits to clinic and infusions. This will be widely adopted and is a meaningful advance in immunotherapy.

quotes

Reply

H. Jack West, MD (Posted: April 27, 2020)

quotes

We should be very skeptical that this trial will change treatment. This trial is essentially a replication of the KEYNOTE-024 trial of pembrolizumab vs. chemotherapy as first line treatment for patients with advanced NSCLC and high tumor PD-L1 expression. We have learned that this trial produces results that do not seem materially different, specifically not incrementally better, than pembrolizumab in the same setting. Pembrolizumab is well established here, and it is incumbent upon Regeneron to produce a clear reason to favor cemiplimab over pembrolizumab -- specifically, it would need to show significantly superior efficacy, significantly lower toxicity, or significantly lower cost. I suspect that lower cost is the only realistic angle here, and I would be floored if Regeneron breaks the pharmaceutical mandate that treatments must inviolably cost more over time, no matter whether they provide meaningful improvements or not.

quotes

Reply

William McGivney, PhD (Posted: April 27, 2020)

quotes

Here we go again! It is important and necessary to keep pointing out the intrusion of PBMs into medical decisions that impact the lives of patients with serious and life-threatening conditions, in our case, cancers. The JOP article repeats a 2018 survey and confirms the findings of an “opaque” system of utilization management activities. “Clandestine” and “surreptitious” might be more apt descriptors.
Again, this opaque system persists despite the fact that executives in PBMs would not want decisions about their or their family’s treatment for cancer made by their own minimally-qualified UM overseers. Certainly, the same sentiment resides in regulators, legislators etc.
I know from my experience at a major insurer, wherein in my final days I was put in charge of the UM docs, that I would never have wanted any of them to be involved in any manner whatsoever in a clinical decision that impacted anyone who I knew and cared for.
I keep telling the same stories of a senior lawyer at that insurer that I worked for telling me upon her departure that the best thing about leaving was that she would not have to say again that we do not make medical decisions.
Also, I have recounted the story of the world-renowned NCCN Panel Chair who had a cardiology PBM nurse explain to him the meaning of an NCCN recommendation. He listened and then kindly informed her that he had been the Panel Chair for 20 years and this is what the recommendation actually meant.
The administrative waste, the opacity of financial arrangements, the denial of optimal first treatment, the patient frustration and anguish just do not seem to raise the issue to a point where we might see change.

quotes

Reply

H. Jack West, MD (Posted: April 23, 2020)

quotes

Having the FDA-approved option of an every 6 week administration of pembrolizumab would represent an important advance in general, but this is an invaluable alternative in the new world we're living in, where every seemingly routine visit to the oncology clinic poses a non-trivial risk of exposure to coronavirus. This schedule will be widely favored whenever pembrolizumab monotherapy is a leading consideration and could lead to favoring of pembrolizumab over other alternatives in settings in which other checkpoint inhibitors would also be on the short list of treatment approaches.

quotes

Reply

Thomas Marsland, MD (Posted: April 21, 2020)

quotes

So we too have been increasing the use of telemedicine in our practice. Just a couple of thoughts to share with my 3 week experience. Indeed the patients are receptive. They do appreciate not having to be exposed to potential infection sources. In my patient population however (older, less affluent) many are not able to do true video meeting and most have defaulted to telephone meetings (there is an economic issue there...). I am somewhat struggling with the need for physical exam in some of the follow ups. Have yet to figure out how to do a breast exam by phone...(please put the phone over your breast....doesn't work...) As the sage said you can never really go home again; I suspect that life will never be the same. We are being drug (kicking and screaming on my part) into the world of telehealth. But it is here to stay. As I said in a prior comment we really need organized medicine to look into the long term economic impact on clinical practice.

quotes

Reply

H. Jack West, MD (Posted: April 20, 2020)

quotes

We need to see the actual data, but significantly improving overall survival as first line therapy compared to standard chemotherapy (cisplatin or carboplatin with pemetrexed) should be sufficient to lead to regulatory approval and likely become a new standard of care. If only marginally better in absolute terms, some may favor a platinum/pemetrexed option with bevacizumab, which has also demonstrated a significant improvement in OS vs. chemo alone but hasn't been FDA approved and remains an option that is only intermittently pursued.

quotes

Reply

Howard S. Hochster, MD (Posted: April 19, 2020)

quotes

The FDA has approved a new formulation of Mitomycin C (MMC) in hydrogel (4 mg/ml) solution for instillation in the ureter or calyces to treat low grade Upper Urinary Tract Urothelial Cancer. This will certainly be of great benefit to some patients with these tumors. The approval is based on a single arm multi-center trial with no controls, based on the primary endpoint of CR by ureteroscopy and cytology at 3 months. Despite UroGEN calling this OLYMPUS study a "phase 3 trial" it meets no definition of "Phase 3." The study showed 58% of patients had CR at 3 months (later timepoints not yet revealed) and the approval is apparently based on historical controls and the fact that standard practice frequently involves nephrectomy. This finding is not unexpected, given the activity of MMC in NMIBC and it approval.

This is another in a series of "better mousetrap" formulations of active drugs making FDA approval without appropriate controls. Why not a standard MMC solution as a control group? Or even the much more available and less expensive Gemcitabine, which is equally active in NMIBC? How much does the hydrogel contribute? This is unknown. The FDA should really require the parent drug as the comparison in such re-formulated agents including nab-paclitaxel and lipsomal irinotecan. It is no service to the oncology community to approve drugs based on activity similar to the parent compound compared with inferior controls, and without a direct comparison. These create very expensive new drugs with unknown advantages. We should know exactly how much better such improved formulations are compared with the parent for the extra cost. FDA: please consider appropriate controls!

quotes

Reply

Debu Tripathy, MD (Posted: April 17, 2020)

quotes

The approval of tucatinib is a first in many ways. Most importantly, it demonstrated a survival improvement in later lines of therapy – following on notable successes with pertuzumab and T-DM1 in first and 2nd+ lines. Also, it is the first HER2-specific agent in the clinic – targeting the proven HER2 “driver” without side effects due to blockade of closely related HER1 (EGFR). Importantly, it is the first trial to demonstrate improvements in outcome in patients with a history of CNS involvement that constituted about half of the enrolled patients, with 18% actually progressing in the CNS as allowed on the study. It will now be a new standard beyond first line therapy (depending on agents previously received). Many trials are now ongoing or planned to test tucatinib such as a trial in the most aggressive form of CNS disease – with leptomeningeal involvement (HER2+), as well is in early stage breast cancer for patients who have residual HER2+ breast following neoadjuvant therapy.

quotes

Reply

H. Jack West, MD (Posted: April 13, 2020)

quotes

An important development, but I'm one of many people in the oncology community who feels we need to see an overall survival (OS) benefit before considering an adjuvant therapy as a new standard. The goal in this curative setting is to improve OS, not to make the scans look better in the first couple of years but have people live just as long in either arm.

We know from the phase II SELECT trial that adjuvant EGFR TKI can improve disease-free survival (DFS), but it hasn't been shown to improve OS yet. Giving adjuvant osimertinib means that everyone receives treatment for up to three years, at >$20K/month, despite the fact that many of these people are already cured without any further intervention. We know that osimertinib is extremely effective upon relapse, and patients on the control arm MAY do every bit as well, responding for years at a time, probably significantly better than the median progression-free survival (PFS) and OS seen in patients diagnosed with stage IV disease (those who relapse after presenting with earlier stage disease routinely have a more prolonged natural history than those with "de novo" stage IV disease). Moreover, some with "oligo-relapse" may even possibly be cured with local therapy as consolidation to the site(s) of relapse, especially if combined with osimertinib.

The critical question is whether OS is exactly the same by sparing half of the patients osimertinib and only giving it, as needed, to those who relapse.

The fact that AZ moved forward with DFS as the primary endpoint is exactly what a company would do if the goal is to sell the most osimertinib possible. If the goal is to help patients and society, OS is the endpoint that matters. And if the FDA approves osimertinib based on DFS, it doesn't mean that it's actually the right endpoint, but rather it highlights that the FDA suspends judgment on judicious critical thinking in favor of maintaining good relationships with the pharma companies that pay PDUFA fees to get their drugs rubber stamped for marketing, not critically reviewed for meaningful benefit.

If the ADAURA trial shows an OS benefit, it will also be critical to see what proportion of the patients on the control arm get osimertinib, either as initial treatment or ever. Too often, these randomized trials are conducted in countries with health care systems that provide woefully inferior off-protocol treatment that rigs the trial to favor the investigational arm, because the standard arm never gets fair access to the same treatment later. AZ unequivocally declares osimertinib to be the first line standard of care for EGFR mutation-positive NSCLC, and the key question should therefore be whether adjuvant osimertinib for all provides an OS benefit over osimertinib +/- local therapy consolidation upon relapse. But I strongly suspect that AZ isn't offering automatic access to osimertinib upon progression. Why not? Because it's effective enough that they want to hobble the control arm by leaving them to get inferior care in the health care systems that don't have access to osimertinib.

If we see that only 50% of patients who relapse on the control arm ever get access to osimertinib, AZ will then promote adjuvant osimertinib in the US based on a trial rigged to favor the investigational arm because the trial wasn't about timing of osimertinib, but upon access to it at all, despite the fact that AZ calls it the unequivocal standard of care.

What's worse is that we can be sure that both docs and patients will very often be disinclined to stop osimertinib after 3 years, despite that being how the trial was designed. For those who were already destined to be cured, it will become "shark repellent" (attributed to warding off a threat that isn't real), used for no value, indefinitely, by people sure that they didn't relapse because they're taking a pill that costs "society" but not them $20K/month. And based on the eagerness of many of my colleagues to extrapolate molecular oncology data well outside of where the evidence provides clear support, we can also be sure that osimertinib will be given as adjuvant therapy for far too many resected 1.9 cm solitary EGFR mutation-positive lung tumors, just because...there's too much gravitational pull once you know the mutation status to limit to where there's actual evidence.

The oncology community cannot be gaslit by the pharma industry into accepting lower standards for adopting new therapies merely because it is a lower bar for pharma. This should be a line in the sand, and we should be embarrassed by our gullibility and lack of critical thinking if we are complacent enough to accept DFS here.

quotes

Reply

Thomas Marsland, MD (Posted: April 09, 2020)

quotes

Thanks Ted, for your usual good insight and comments. Clearly the world is changing and will never be the same again. I certainly with interest noted several of the other reports today discussing telehealth. Medicine has been dipping our toe into that pond but the covid pandemic has thrown us into the deep end, sink or swim. With that said, clearly there are many things that we cannot do digitally. Have yet to see a computer program that allows us to administer chemo. I agree with COA that home infusions represent a path that is fraught with problems. Safety and adequate staff resources being just a few. Also in today's report there was a comment on the ecomonic impact of covid on oncology practices. I think that we need an in-depth study on the whole concept of telemedicine on the economics of practice. From a purely health delivery perspective, there are many services that can be adequately provided via phone or digital interactions. The appropriate codes for these generally provide significantly lower value compensation than the more traditional face-to-face codes. How will the transition to digital healthcare effect the viability of community (and indeed hospital) oncology practice? That question needs an answer.

quotes

Reply

Howard S. Hochster, MD (Posted: April 09, 2020)

quotes

Good news for colon cancer patients - for the few with BRAF V600E mutation - we now have the option of encorafenib and cetuximab resulting from the phase 3 BEACON trial. This arm was superior to FOLFIRI (or irinotean) with cetuximab control. Also of note, the triplet with addition of binimetinib to encorafenib/cetuximab was not any better than the doublet. This doublet result compares favorably to the SWOG randomized phase 2 trial with ICV (Irinotecan, Cetuximab, Vemurafenib) though without use of chemotherapy. We still need to define the role of chemotherapy for these patients and we also need to define the role of BRAF inhibitors in first line therapy. More studies are needed but the approval of encorafenib gives another important drug option for this subset of patients.

quotes

Reply

H. Jack West, MD (Posted: April 08, 2020)

quotes

We have yet to see the results of the CheckMate-9LA trial, upon which this application is based, but the concept of a very limited course of chemotherapy with a PD-1/CTLA-4 inhibitor combination has some appeal as a rationale. This strategy gives us a couple of angles to get immediate control over the cancer, more than either chemotherapy or immunotherapy alone, but without the longitudinal maintenance with both chemotherapy and immunotherapy that may be more than necessary and associated with cumulative toxicities, or at least higher ongoing cost than necessary.

Obviously, we need to see the data and how they compare to the many other evidence-based options that represent competing standards of care for first-line treatment in this setting.

quotes

Reply

Howard S. Hochster, MD (Posted: April 02, 2020)

quotes

Interesting news on the KEYNOTE-177 first line MSI-H colon cancer trial. This is a 1:1 randomization of single agent pembro vs chemo (FOLFOX or FOLFIRI [plus bev] physician choice). It is good to discover that PFS is longer for the pembro arm, as announced here, but we still need to see the data. We need to see the actual Kaplan-Meier curves to see if this shows a cross-over, as in multiple gastric cancer trials reported to date. For example, in KN-062 chemo was better for the first 9 months then the pembro arm was better; also pembro plus chemo was not better. Encouraging news! But not yet definitive. Please consider the NCTN COMMIT trial comparing chemo +/- atezo for first line metastatic MSI-H CRC - still accruing!

quotes

Reply

Fred J. Pane (Posted: April 02, 2020)

quotes

These are the types of questions and answers being made in Europe in many socialized medicine countries. I read an article that one country is looking at patients 65 and over, who don't have a life expectancy beyond 3 months, who test positive for COVID-19, to not be placed on a ventilator. I am not sure if people have advanced directives, living wills, DNR, etc. in these cases. My dad was diagnosed with Esophageal Cancer late last year, is 86, and just finished radiation and chemo. As a clinician and son, what would you do?

quotes

Reply

Dean Gesme, MD (Posted: April 01, 2020)

quotes

The reported low false positive rate in this large validation data set and high diagnostic acumen for the cancer primary sites rpresents an extremely promising first step. The vital next step is to determine the false negative rates and whether this technology can allow early enough detection of malignancies to afford significant outcomes benefits in real world data sets.

quotes

Reply

William McGivney, PhD (Posted: March 30, 2020)

quotes

Kudos to CIGNA and to Humana and all those who helped drive the decisions of these two large health insurers to waive copays for the treatment (e.g., hospitalizations) of patients related to the coronavirus. While I am not a fan of payers/MCOs, the leadership of these companies exemplifies that we need to all fight together in this war against the coronavirus. The last thing that any sick person needs to worry about are negative financial implications of seeking medical help when they are in substantial need. Mitigation activities and aggressive treatment of patients serves all of us in ultimately reducing our own risks and facilitating the elimination of this virus as a risk to our country and to our planet. Finally, God Bless all the front-line clinical professionals! God Bless us all!

quotes

Reply

H. Jack West, MD (Posted: March 30, 2020)

quotes

This provides another option that is pretty much a lateral move compared to atezolizumab with chemo in the IMpower133 trial. Both efficacy and tolerability data appear very similar. One modest difference is that the CASPIAN trial gave durvalumab with a chemo regimen of either cisplatin or carboplatin along with etoposide, while the IMpower133 chemo backbone was carbo/etoposide only. Accordingly, for those who routinely favor a cisplatin-containing regimen in extensive SCLC, the FDA approval of the CASPIAN regimen may resonate more for them.

quotes

Reply

Howard S. Hochster, MD (Posted: March 26, 2020)

quotes

There is no question that SARS-CoV-2 will prove to be a major challenge to all health care providers in the coming weeks. At the Rutgers Cancer Institute of NJ we have moved aggressively to reduce staff and patient exposure by seeing as many follow up visits by Telemedicine video chats. We are calling to pre-screen every patient coming in for possible symptoms or exposure, and screening again at the front door. However, we continue to treat all patients on active therapy at this time as "essential services". We are continuing cancer surgery at this time in the same way. At the moment we are prioritizing patients with cancer diagnosis for treatment as usual, and will continue to do so as long as we have the resources.

quotes

Reply

Ronald Yanagihara (Posted: March 24, 2020)

quotes

Should it not be relatively easy to document how many patients who died of covid19 respiratory failure also happened to have been on chronic hydroxychloroquine for SLE, etc?

quotes

Reply

H. Jack West, MD (Posted: March 24, 2020)

quotes

An excellent piece that highlights what the history of cancer research should be teaching the world about the concept that trying things with the thought that "they can't hurt", based on a "don't just stand there -- do something!" mentality are actually harmful and counterproductive, not only to broader society, but also to the people short-circuiting deliberate, appropriate research. And President Trump is unfortunately not helping by undermining thoughtful medical care and the cautious advice of the profoundly knowledgeable people like Dr. Fauci.

quotes

Reply

Veronika Bachanova (Posted: March 20, 2020)

quotes

We ask that you request all private health insurance companies serving the Medicare Advantage, Managed Medicaid, and the commercial insurance markets to immediately waive all “prior authorization” requirements for cancer treatments during this COVID-19 crisis. Dear Mr. President: We are writing this urgent letter on behalf of the Board of Directors of the Community Oncology Alliance (COA), an organization representing community oncology practices that treat the majority (more than half) of all Americans with cancer. Unfortunately, cancer does not stop for any crisis, and patient treatment must continue during this national emergency.

quotes

Reply

H. Jack West, MD (Posted: March 17, 2020)

quotes

The CASPIAN trial was positive for a survival benefit with durvalumab added to platinum/etoposide for first line treatment of extensive stage small cell lung cancer, which is now added to atezolizumab + carbo/etoposide as another option (a lateral move), at least once the FDA provides expected approval.
The story shouldn't be around positive results for durvalumab alone. That's old news, and it was never that interesting to clinical oncologists who already have an FDA-approved chemo/immunotherapy combination in first line SCLC, with chemo/durva offering no benefit over that.

The failure of the arm with durvalumab/tremelimumab added to chemotherapy, however, is another hit to this immunotherapy doublet that has demonstrated repeated failures in many settings. My opinion is that AZ needs to cut its losses and stop pursuing this combination. In the event that a rare trial comes up as positive with it, it will still suffer from being in the context of now a growing array of negative trials with durva/treme, and also with being compared to a nivolumab/ipilimumab combination that is very similar, except that nivo/ipi has demonstrated far more success.

As far as durva/treme is concerned, this dog won't hunt.

quotes

Reply

William McGivney, PhD (Posted: March 15, 2020)

quotes

I know that I quoted that health care policy sage, Yogi Berra, a few commentaries ago, but his wisdom applies yet again to this communication of “Principles” on drug pricing reform to Congress. What is a more apt description than that “It seems like déjà vu all over again”. These principles must have been written by some eager young staffer who consulted a first-year undergraduate health policy textbook. In my long career, I am used to seeing policy pronouncements restate what was “hot” a few years back but calling it with a different name such as “Rapid-learning health system” replaces “evidence-based medicine”. I even remember the CEO of a large national organization providing me with the Rapid Learning 101 lecture at one time; thinking that he was introducing some novel concept.
Anyway, it appears that we are going back to the starting line on Congressional drug pricing reform discussions. How informative will “Give insurance companies an incentive to negotiate better prices for costly drugs”, be to the process of shaping legislative pieces that already have been under considerable consideration. Rather, this brief set of principles sounds like a communication to be used in campaign messaging.
Given that the current coronavirus situation appropriately commands most of the health care system’s attention, energy, and efforts, it is likely that this eye-opening listing of “Principles” will receive the perfunctory consideration that it deserves.

quotes

Reply

William McGivney, PhD (Posted: March 07, 2020)

quotes

As more and more national (USA) meetings across a host of major industries are cancelled, expectations for major cancer meetings that are soon to be held are of major consequence. The AACR released a statement on March 5 indicating that “we are still planning to hold the Annual Meeting in San Diego, April 24-29”. The next day on March 6, the NCCN announced the postponement of its 2020 Conference and associated events to be held on March 19 through March 22. As Dr. Carlson, the NCCN CEO, said; “ This was an incredibly difficult and disappointing decision to have to make”. But cancellation was necessary to safeguard all from potential exposure to COVID-19.
Having been the CEO of NCCN a few years ago, I truly recognize the difficulty and myriad of complex issues to be considered in making such a postponement decision. But as physicians seek “first to do no harm”, Dr Carlson and his colleagues clearly made the correct decision for all involved. I would expect no less from Dr. Carlson who in 2008 was presented with the prestigious National Physician of the Year award.
The logistics to be considered (e.g., hotel and vendor contractual obligations, lost revenue) and addressed are substantial, but the health and well-being of attendees, employees, vendor personnel, etc. clearly far outweigh all other considerations. Larger cancer organizations will be soon be making their own decisions. Clearly, senior staff at those organizations will be facing an increase in the number of patients diagnosed as positive for coronavirus. Some of these meetings tend to attract a much larger share of international attendees than the NCCN. Given the greater size, logistical complexity and potential impact on the health of those present at their meetings, I would expect to see definitive decisions in the very near future.

quotes

Reply

H. Jack West, MD (Posted: March 05, 2020)

quotes

This is clearly a question on everyone's mind right now, more pressing every day, as many institutions are announcing new policies discouraging if not strongly restricting non-essential travel, including to conferences. Moreover, it's inevitable that there will be dozens to hundreds of COVID-19 carriers at ASCO, given so many asymptomatic or ambiguously symptomatic people and cases no longer tethered to global travel. This means that these conferences will bring thousands to tens of thousands of oncologists and others from around the globe in close contact with COVID-19. It would be hard to envision a more perfect path to a pandemic, as these people will then bring COVID-19 home to expose their patients, colleagues, and families.

Though these large annual meetings are important for galvanizing the cancer community, for sharing information, and for providing great financial support for these professional societies, this is clearly a year in which there will be a great need for live streaming and/or other robust virtual meeting options, if it is feasible and not socially irresponsible to proceed with these live meetings at all, at least on their current time lines.

quotes

Reply

Dean Gesme, MD (Posted: March 03, 2020)

quotes

The repurposing of FDA approved drugs could offer a partial solution to the astronomically escalating costs of de novo drug development, I hope that all physicians involved in clinical trials will devote a part of their efforts to identifying efficacious existing agents that could also address the issue of financial toxicity produced as a result of de novo drug development.

quotes

Reply

H. Jack West, MD (Posted: February 24, 2020)

quotes

Unfortunately, the most recent results from the ALTA-1 trial of brigatinib vs. crizotinib as first line therapy in ALK-positive NSCLC look numerically inferior to those seen with alectinib in the ALEX trial of essentially the exact same design. With alectinib as a clear first line standard of care for ALK-positive NSCLC, I don't see a clear path to why one would favor brigatinib over alectinib. Yes, once daily dosing and far fewer pills, but the ALTA-1 results were relatively disappointing and cemented alectinib into my first line treatment plans for patients with ALK-positive NSCLC.

quotes

Reply

William McGivney, PhD (Posted: February 23, 2020)

quotes

Clearly, our fight against CancerS is a series of enormous battles against hundreds, and maybe many more, of diseases driven by various gene aberrations, RNA sequencing alterations, protein disruptions, etc. One thing is for sure, science and clinical medicine are advancing to control, attenuate, and, even eliminate patient tumors in diseases for specified patient subpopulations. It is understood that the rate of benefit for patients even in diseases where therapies demonstrate efficacy usually involves a minority, albeit a significant one, in most cancers. The list of targets for therapeutic drug/biologic development continually expands even as the interactions between these recognized targets and subtle “unrecognized targets” manifest themselves. We are making important progress.
I went back and read the article by Mr. Horgan about his “talk”. The second sentence alludes to “the enormous gap between the grim reality of cancer medicine and the upbeat claims by the cancer industry and its media enablers”. Sounds like a somewhat cynical opening to me. Two paragraphs down, “the spawning of a “huge industrial complex” of many factions is proffered. As such, the illustration of a sprawling, unfeeling conglomerate of business-driven entities is to be pictured. The article highlights in boldface “Little Net Progress After 90 Years, Besides Anti-Smoking Efforts”. Then comes the out-of-context statement "Immune therapies trigger severe side-effects, and they are extremely expensive…..”. From me, the immune-mediated adverse events associated, for example with checkpoint inhibitors, can be severe but they are low frequency-occurrences that clinicians have learned to identify early and manage. This latter context is nowhere to be found in Mr. Horgan’s discussion.
To be fair, there is a smattering of comments recognizing positive aspects of what has been accomplished. There also is recognition on agreed-upon findings that some diagnostic tests (e.g., PSA) have led to misdiagnoses and some areas of overtreatment. Clearly, though, we all, as components of that “sprawling Industrial complex”, have a considerable way to go in our fights against these hundreds of diseases. But the progress made in the past twenty years fuels our energies and our hopes to win the battles, cancer subpopulation by cancer subpopulation. For it is when people are diagnosed with cancer and then want to see themselves in the top decile of responders, that what Science and Medicine have wrought in treatment advances truly offers, not hype, but hope to patients in need.

quotes

Reply

H. Jack West, MD (Posted: February 19, 2020)

quotes

The results with atezolizumab in this highly enriched subset echo the findings with pembrolizumab in patients with tumor PD-L1 expression of 50% or higher in KEYNOTE-024, and again in KEYNOTE-042. Pembrolizumab is well established and FDA approved in this setting, and the 22c3 antibody for PD-L1 is the highly dominant standard molecular diagnostics test for PD-L1.

The IMpower110 study shows very comparable benefit with atezolizumab in an even more selected subset of patients, using an antibody and testing method that is decidedly non-standard. I assume the FDA will approve single agent atezolizumab here, but there is no way in which atezolizumab monotherapy appears superior to the far more established standard of pembrolizumab in a broader but extremely similar population being tested with a far more widely used assay.

quotes

Reply

Howard S. Hochster, MD (Posted: February 18, 2020)

quotes

Another "swing and a miss" in pancreatic cancer. Despite numerous trial of chemotherapy plus targeted drugs, and now plus IO drugs, we have not seen a benefit. Cabiralizumab had more than the typical preclinical data (and hype) as it is an antibody to CSF1 on infiltrating lymphocytes and especially TAMs (Tumor Associated Macrophages) which are believed to be immunosuppressive. The antibody would block this kind of immunosuppression and allow anti-PD1 to work (like in melanoma!). Unfortunately this simple solution was not to be. So far finding effective IO approaches to pancreatic cancer still remains the "holy grail".

quotes

Reply

William McGivney, PhD (Posted: February 17, 2020)

quotes

Every once in a while, in my columns, I mention that Rick Pazdur, MD of the FDA NEEDS to be recognized for how he has positively impacted the lives of thousands of patients with Cancer and their Caregivers. Dr. Pazdur has had remarkable success in speeding up FDA approvals for many, many drugs and biologics while at the same time maintaining a process that continues to assure assiduous evaluation of the safety and efficacy of these products. Dr. Pazdur deserves to be awarded the Presidential Medal of Freedom for what he has done in his own quiet way for the people of this country.
While Yogi Berra and Chita Rivera were recognized for their contributions with the Presidential Medal, to me, saving and extending the lives of thousands of patients with cancer transcends what may recipients achieved or contributed. Dr. Anthony Fauci is a deserved winner for his tireless efforts to combat the AIDS epidemic and AIDS, the disease. I strongly believe that Dr. Pazdur has worked in the same sphere of achieving good as Dr. Fauci. I have had only had 2 very brief and casual conversations with Dr. Pazdur, so I am not looking to “get something for a close friend”, just for a highly deserving humanitarian.
At the opening of the Yogi Berra Museum and Learning Center, Mr Berra said eloquently: “I’m lucky. Usually you’re dead to get your own museum, but I’m still alive to see mine”. It is past time for Dr. Pazdur to receive the recognition and Thanks that he so richly deserves. I have spoken with national cancer provider organizations that agree with my proposal. Let’s work to get this done!

quotes

Reply

Debu Tripathy, MD (Posted: February 12, 2020)

quotes

This is a notable finding as the first potentially practice-changing results for the use of immunotherapy in early stage breast cancer. It has already been shown that pembrolizumab can improve pathological complete response (pCR) rates when added to standard chemotherapy for triple negative breast cancer from this same trial (and in the previously reported I-SPY2 trial for hormone receptor-positive breast cancer as well). We also know that pCR is a reasonably good surrogate for disease-free survival. While the FDA has evaluated pCR rate as a possible approvable endpoint, additional data is still needed for the relatively new field of immunotherapy (at least “new” for breast cancer). This is the data that is needed for ultimate approval and entry into clinical use. We eagerly await the details of the trial results – it will be a welcome addition to our treatment protocols designed to prevent metastatic recurrences if the short and long-term toxicities are acceptable.

quotes

Reply

William McGivney, PhD (Posted: February 11, 2020)

quotes

The Pennsylvania legislation described here in the brief article hopefully will serve to do away with an abhorrent practice of payers who put patients and caregivers through an emotional and financial wringer as such payers presume that they can best prescribe for a patient with cancer. That payer-intrusive recommendation often represents a tactical delay that seeks to impose a “fail first” temporal sentence on patients in need who have little extra time to have their treatment directed by that payer.
Indeed, this Pennsylvania legislation (and in other states) is a positive but the glass is half-full. As I have often opined:
1. The next version of legislation should cover all recognized off-label uses (e.g., NCCN);
2. Precertification for patients with Cancer should be made illegal.
3. When a payer makes a medical necessity determination, that payer is involved in the practice of Medicine and should be so liable.

quotes

Reply

William McGivney, PhD (Posted: February 06, 2020)

quotes

Almost all of us will be patients with a serious illness at some point in our lives. As such, how we feel, how we can function, how we view our survival and mortality, etc. are among the critical components of a quality life. My last sentence demonstrates the overlap of concepts (e.g., QOL and PROs) and sometimes the confusion behind what is being measured on top of the collection of safety and efficacy data. Clearly, the move by EORTC to attempt to “standardize the analysis of PROs in RCTs” will help. Quite frankly, I am not sure what the statement in quotes means exactly, but I do not prioritize the issue highly enough to pull more time away from my other efforts.
Notwithstanding that, I do know that in the United States the application of the results of formal PRO assessments, long- and much- talked about, achieve only minor attention in policy-setting and in clinical decision-making. I remember about 5 years ago, being on a public Panel and being asked the first question. With significant timidity, I gave the answer per the above sentence. I thought that the patient advocates, one biopharma rep, and the one government policy person on the Panel would shower me with disdain. Interestingly, I had broken the ice and spoken the truth. My colleagues on the Panel actually responded in general agreement with me. I had made it okay to come out from behind the curtain of political correctness that we see so often on such Panels.
PROs are important. But where do they fall in the cascade of issues and wants of the patient? To my mind, patients always see themselves in the upper decile for survival. Patients certainly want to understand the probabilities and degree of pain and discomfort certain Adverse Effects of selected drugs/biologics and other treatments can bestow. As above, the identification of and definition of such outcomes and others (QOL and its component parts) are all relevant. But to date, regulators, payers/MCOs and clinicians in the US generally focus on traditional explanations of risk/benefit in terms of safety and efficacy in their policy setting and decision-making. A 2019 study (Toumi et al, Recent Results Cancer Research) supports this statement.
The allotment of valuable and limited resources such as time and money requires the hierarchical prioritization of which outcomes to evaluate in a rigorous, scientific manner.
The effort in Europe to achieve more directive, clarifying standardization for PROs is important. It will be interesting to review again in 5-10 years to see where we are with the assessments and application of PROs in decision-making in the US.

quotes

Reply

William McGivney, PhD (Posted: February 04, 2020)

quotes

The work of COA has been critically important in the support of patients, practicing oncologists, and the enhancement of innovation.
One opportunity that lays wide open out there is the recognition in the OCM model that the NCCN recommendations lead the way in providing innovative off-label uses for drugs and biologics. As a matter of fact, of the first 88 indications for the checkpoint inhibitors, 58% of such indications were based upon NCCN recommendations for off-label uses. The NCCN Guidelines/Drugs-Biologics Compendium clearly represent the standard of care in Oncology in the US. NCCN recommendations are primary drivers of coverage policies of payers/MCOs. As such, under the OCM, new NCCN recommendations for the use of drugs/biologics should qualify for "novel therapies payments" within the OCM program. Limiting such "novel therapies payments" to only FDA approved indications clearly shows either a lack of understanding of the impact of NCCN on coverage policy and prescribing or a resistance to truly accelerate innovation through a payment system that seeks to best satisfy the needs of patients with Cancer.

quotes

Reply

Howard S. Hochster, MD (Posted: February 04, 2020)

quotes

The results o f IMbrave 150 for Child-Pugh A HCC should set a new standard for treatment of advanced HCC and the sBLA should be rapidly improved. This global study randomized (2:1) Atezolizumab and Bevacizumab (both iv q3w) vs sorafenib 400 mg bid. The OS showed 42% improvement with HR of 0.58 (p=0.0006). PFS and RR were both statistically improved with the IO arm. This was the single positive study presented at GI ASCO with prior results at ESMO-Asia and PRO data showing similar improvement in HR for deterioration in QOL, Physical Function, Role Function (with HR 0.53-0.63), favoring the experimental arm. This represents a substantial treatment advance over sorafenib for HCC.

quotes

Reply

Helmy Guirgis, MD (Posted: February 03, 2020)

quotes

Wise decision. Pembro monotherapy and Pembro-chemo are a high mountain to climb

quotes

Reply

H. Jack West, MD (Posted: February 03, 2020)

quotes

Sad how difficult it is to beat topotecan monotherapy as 2nd line treatment in small cell lung cancer. A reviled standard of care that many thoracic oncologists think so little of it that their preferred alternative is "anything but topotecan". And yet it survives, trial after trial, like a cockroach after after a nuclear war.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: January 30, 2020)

quotes

The magnitude of the OS benefit will be of significant interest. Three agents have been approved in this setting based on metastases-free survival results with overall survival not mature. This is the first report that overall survival is improved. This would be expected given that this class of agents improved OS in metastatic disease, but it is reassuring that such results are being confirmed in the non-metastatic population. However, the available press release provides little details and the actual results are eagerly awaited.

quotes

Reply

H. Jack West, MD (Posted: January 30, 2020)

quotes

The difference in favor of chest CT screening is truly remarkable. The only controversy around this observation is, in the wake of prior work that also demonstrates a significant survival benefit, why is chest CT screening so woefully under-performed in the US and most of the rest of the world?!

quotes

Reply

H. Jack West, MD (Posted: January 29, 2020)

quotes

Selpercatinib is a spectacularly active drug against RET fusion-positive NSCLC, among a few other entities. An approval will be a great benefit for the small molecularly defined subgroups in whom it has been well studied. Once that happens, selpercatinib will merit strong consideration as a first line treatment, or as early as feasible after that.

quotes

Reply

William McGivney, PhD (Posted: January 27, 2020)

quotes

The article (with totally ex-US authors) referred to was published in the British Medical Journal in 2020. It comes to two main conclusions:
1. Industry funding of patient groups seems to be common, with prevalence estimates ranging from 20% to 83%. Few patient groups have policies that govern corporate sponsorship.
2. Industry funded groups tended to have positions favourable to the sponsor. Patient groups have an important role in advocacy, education, and research, therefore strategies are needed to prevent biases that could favour the interests of the sponsor over those of the public.
For patient advocacy groups and for provider organizations, educational efforts and programs in need of funding can look to two sources for funding, biopharma companies and payers/MCOs. Clearly both of these industries achieve substantial revenue each year. The biopharma industry is quite interested in and generous in funding such programs that are tightly bound by rules about industry involvement (basically none) that biopharma companies can have in determining content, speakers, etc. The other source of funding is the managed care/health insurance industry. This latter industry is characterized by stinginess and a miserly nature.
When I was CEO of an influential provider organization, I listened to the ongoing mantra about the same issue. So, one year, I decided that every time that my organization would ask for money from biopharma, we would submit the same educational or informational funding request to insurance companies. That year, we had a perfect record in that all 35 of our requests to insurance companies were turned down, or in some cases, were not responded to at all! C’est Ca for issue #1! Or C’est la guerre!
In terms of issue number two, it occurs to me that patients, providers, and biopharma companies are aligned in seeking to achieve the availability of and access to novel drugs and biologics that address the many unmet needs of the many cancers for the many, many patients in need. As such, would anyone be surprised to see that patient groups, funded and unfunded, actually generally have the same policy positions as biopharma companies do.
These are important issues to raise but it would be good if a small dose of reality, and yes, common sense, could permeate the grey matter of those involved in study design and analysis, as it is likely that this issue will be raised continuously over the course of our careers!

quotes

Reply

Howard S. Hochster, MD (Posted: January 24, 2020)

quotes

Interesting but not overwhelming response rates, especially when compared with pretreated patients who then received atezolizumab and bevacizumab. The new question in GI cancers - do TKIs turn anti-PD1 drugs into active agents for the otherwise not very responsive tumors? Time (and hopefully phase 3 trials) will tell.

quotes

Reply

H. Jack West, MD (Posted: January 23, 2020)

quotes

The main limitation I see here is that we're increasingly looking for a wider range of potentially clinically relevant mutations than just EGFR. Whether as part of an initial workup or in the setting of acquired resistance to a targeted therapy, we're looking for more than one target at a time now.

quotes

Reply

William McGivney, PhD (Posted: January 17, 2020)

quotes

The header for this subject states that while drug/biologic approvals have arrived faster at the FDA over the past four decades, “the evidence it relies on in making those decisions is getting weaker”. Further in clicking the link to the article one finds the quote “As a result, patients and physicians should not expect that new drugs will be dramatically better than older ones."
Only a few headlines up in the list of news in Today’s OBR Daily is the headline “Cancer Research Booms, Cancer Mortality Falls”. So, we have the sound bites:
1. Drug approvals by FDA are faster
2. Cancer Research Booms
3. Cancer Mortality Falls
4. The evidence is getting weaker
5. Should not expect new drugs to be better than old ones.
Thus, we have the construct (Merriam definition: “as a contrast between lived reality and the construct held in the mind”) that the evidence for such decisions is getting weaker. Okay, I will accept so-called “weaker” evidence if I can get quicker access to drugs/biologics that, from 1991 thru 2017, helped to drop the cancer death rate by 29%. For those about to pounce and say “Yah-But, how much of that is attributable to new drugs/biologics?”, please look no further than to 2016-2017 wherein there was a 2.2% drop in the death rate, the largest annual death-rate drop ever recorded. For my meager money, I’ll take that last statistic no matter the strength of the evidence. As per the Chief Medical Officer of the American Cancer Society: "The accelerated drops in lung cancer mortality as well as in melanoma that we're seeing are likely due at least in part to advances in cancer treatment over the past decade, such as immunotherapy,"
I will extend my analytic diatribe by asking: who would look 40 years in the rear-view mirror to look at the strength of evidence used in approvals by the FDA now vs then. Are we not today in a totally different world, a world of genomes, exosomes, proteomes, etc., with significant advances coming almost monthly, at a rapid pace? Are not the populations of patients in need becoming smaller and smaller as they are exquisitely defined by molecular biomarker disease classifications? As such, how large an “n” of subjects can be generated in a reasonable amount of time to evaluate outcomes for patients in need?
Do we need Double-Blinded RCTs for every evaluation? The FDA rightly is saying “no” and its track record, since the arrival of Dr. Pazdur, is exemplary.
One final comment: “you know what they say ‘Publish or Perish’”. Wow, 40 years ago; even I was still in the Lab at Harvard (not in the Law School), no less!

quotes

Reply

Dean Gesme, MD (Posted: January 13, 2020)

quotes

C-C Chemokine Receptors (CCR5 or CD195) are ubiquitous on immune cells and play a significant role in inflammatory disorders and cancer. Antibodies targeting CCR5 are a welcome addition to our antineoplastic armamentarium.

quotes

Reply

Howard Sandler, MD, MS, FASTRO (Posted: January 13, 2020)

quotes

Radiotherapy as primary treatment (along with TUR and chemotherapy) is having a bit of a renaissance. The BC2001 study, using 5FU and mitomycin along with radiation, demonstrated a non-cisplatin regimen can be effective. Recently published RTOG 0712 (Coen JJ JCO 2019) showed that single agent gemcitabine can be used. Finally, SWOG/NRG have a large open bladder preserving trial testing whether bladder intact survival can be enhanced with immune checkpoint inhibition. Promising times for bladder preservation!

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: January 13, 2020)

quotes

Hot flashes are a common consequence of hormonal therapy for prostate cancer and strategies to treat them are important for quality of survivorship. It is not surprising that an estrogenic drug would be effective. It will be important to learn more about any side effects that might emerge with additional studies.

quotes

Reply

William McGivney, PhD (Posted: January 13, 2020)

quotes

In Oncology, drug/biologic development is clearly in a world of orphan diseases. The FDA defines an orphan disease as one that involves less than 200,000 patients diagnosed or afflicted with the disease in the United States. As such. In general terms, all but the major tumor types can be considered to be orphans. As we progress deeper and deeper into targeted therapies, almost all tumor types and specific indications will be considered to be orphan diseases. The advancement in our knowledge about targets and biomarkers that predict responsiveness of a patient’s cancer will be major determinants of specific diagnoses. As patient populations become smaller and smaller, the pricing pressures on the cost of agents that will be approved for such indications will be great. We will have important increases in the number of targeted therapies in the coming months and years. As such indications will become more "orphan-orphan".

quotes

Reply

H. Jack West, MD (Posted: January 07, 2020)

quotes

Perhaps a bit surprising for pembro, which has had the luck or efficacy to usually be just a shade better than others in its class, but this wasn't going to be a high stakes win even if the trial had been positive for OS. To be clear, KEYNOTE-604 being positive for PFS but negative for OS is definitely not a victory when atezolizumab and durvalumab have already demonstrated positive results for OS in the same setting. At best, a third and very redundant entrant into the same market, unless it had looked significantly better than the others.

The fact that this trial was negative for OS shouldn't leave us agonizing about how pembro is meaningfully different or inferior. In fact, with a HR of 0.80 that barely missed statistical significance, these results are very similar to IMpower133 and CASPIAN (with atezo and durva, respectively), but those came out just a tiny shade better for OS, with results falling on the statistically significant side in those cases, leaving some debating whether the improvement is enough to be truly impressed by those results. As it is, the pembro results in ES-SCLC are very concordant but don't support the concept that pembro is invariably a bit better than other competing anti-PD1 immune checkpoint inhibitors.

quotes

Reply

West (Posted: January 02, 2020)

quotes

These results are quite disappointing. With a 17% response rate for an agent that has very challenging toxicity and a median duration of response of just 7 months, these results are not nearly enough to generate any enthusiasm that poziotinib should be included among the targeted therapies for which we have great enthusiasm and that merit being used early in treatment. We hope to see response rates north of 50% and a median duration of response exceeding 9-10 months alongside a side effect profile mild enough to be compatible with longitudinal therapy.

Poziotinib certainly has some utility, but it appears to be for a much more limited population than we had hoped and would be relegated to a late line of treatment, both because of its modest activity and toxicity issues.

quotes

Reply

Debu Tripathy, MD (Posted: December 23, 2019)

quotes

Trastuzumab deruxtecan (Enhertu), a HER2-targeting antibody drug conjugate, will represent an important new option that is highly active in refractory metastatic HER2+ breast cancer. An impressive response rate of 61% and median duration of response of nearly 15 months was seen in patients who had received a median of 6 cycles of prior therapy. While serious, even fatal, interstitial lung disease has was observed infrequently, this accelerated approval recognizes this area of unmet need.

Another important advance is a recently published and presented registrational Phase III trial testing the HER2-specific kinase inhibitor tucatinib, that will almost certainly lead to a new approval also for 3rd line treatment for metastatic HER2+ breast cancer. When added to trastuzumab and capecitabine, tucatinib improved disease progression by 50% and mortality by 30%, with benefits also seen in patients with treated and untreated brain metastases.

quotes

Reply

H. Jack West, MD (Posted: December 12, 2019)

quotes

I would say that the headline for this is misleading. The key finding is that patients with advanced NSCLC without a KRAS mutation appear to derive little or no benefit from pembrolizumab over chemo alone in KEYNOTE-042. This needs further study, but it is not an endorsement that would lead oncologists to favor pembrolizumab in this setting -- definitely not for those with low tumor PD-L1 expression, and now with a question of whether KRAS wild type (no mutation) should dissuade us from using it in patients even with high tumor PD-L1 expression (50% or higher), in whom we would generally consider pembrolizumab a strong option up to now.

quotes

Reply

Dean Gesme, MD (Posted: December 12, 2019)

quotes

Extremely impressive efficacy in heavily pretreated metastatic HER-2 + breast cancer but the presence of treatment related interstitial lung disease (ILD) is concerning given ILD deaths in over 2% of treated patients and 13.6% all grade ILD. Trials underway in NSCLC and colorectal cancers Will bear close scrutiny for ILD in those populations.

quotes

Reply

H. Jack West, MD (Posted: December 11, 2019)

quotes

Given the remarkable efficacy of selpercatinib, this is a trial that thoracic oncology experts debated the need for. It is arguable that it is worth doing a trial to test whether selpercatinib should be administered first line or is appropriate to defer until later, but selpercatinib has such impressive activity that thoracic oncologists would likely favor the pattern we have adopted for EGFR, ALK, ROS1, and other driver mutations for which the response rate exceeds 50% -- feeling that the "best drug first" approach, especially with a well tolerated agent/regimen, justifies pursuing the targeted therapy first line.

Regardless, the trial will provide some information on a larger scale about the activity of selpercatinib, and the fact that the trial will allow crossover makes it ethically feasible. This will make it harder to interpret overall survival, but that is not the primary endpoint of the study. It will be helpful to see the difference in progression-free survival, likely quite profound, and also what proportion of patients cross over vs. lose that opportunity due to more significant progression.

quotes

Reply

H. Jack West, MD (Posted: December 04, 2019)

quotes

Though I am the first author of the Lancet Oncology publication supporting this approval (IMpower130), I must admit that this indication should be anticipated to have limited utility. It is the same setting for which the combination of carbo/pemetrexed/pembrolizumab is approved and widely used since the April, 2018 presentation and NEJM publication of the KEYNOTE-189 trial (Gandhi et al, 2018). Of note, the IMpower150 trial of carbo/paclitaxel/bevacizumab as the control arm, with carbo/paclitaxel/bev/atezolizumab superior for OS also demonstrated a significant efficacy benefit even in patients with an EGFR mutation or ALK rearrangement (after progression on initial targeted therapy), though this wasn't seen in the EGFR/ALK+ subset on IMpower130 that did not include bevacizumab, suggesting that the inclusion of bevacizumab may be a key differentiator of benefit in this group -- though with the caveat that the subsets are not large enough to draw definitive conclusions.

Overall, the carbo/nab-paclitaxel/atezolizumab regimen, pursued with the concept of obviating the need for steroid premedication that could abrogate the benefit of immunotherapy, is an option that is an appropriate consideration in first line treatment for advanced NSCLC but one that is unlikely to be favored over the far more readily adopted carbo/pemetrexed/pembrolizumab regimen.

quotes

Reply

Howard Sandler, MD, MS, FASTRO (Posted: December 03, 2019)

quotes

Steve Hahn is very well regarded in the ASTRO community. He's a radiation oncologist who is also board-certified in medical oncology. He's been chair of rad onc at UPenn and a leader at MD Anderson. The radiation oncology community is excited for Steve as his nomination proceeds thru the regulatory process and we hope that he's confirmed as the next FDA Commissioner.

quotes

Reply

H. Jack West, MD (Posted: December 02, 2019)

quotes

This will provide a second option in the same setting for which we already have atezolizumab, first line extensive stage small cell lung cancer, and which produces the same results. This will not move the field forward.

quotes

Reply

Thomas Marsland, MD (Posted: November 26, 2019)

quotes

So a tale of two cities.....it is interesting to compare the oncology alternative payment model to the recent one CMMI put forward for the radiation bundle program. The ASCO program clearly comes from the provider community and includes all stakeholders in its design. One hopes that CMS would consider implementing this idea. The Radiation bundle, although well intended, doesn't come from the provider community, is not voluntary, and clearly has not thought out all of the unintended consequences...It carries the potential to radically disrupt access to care. Going forward I hope that CMS proposes more of the programs similar to the ASCO concept and avoids programs like the Radiation bundle.

quotes

Reply

jimmie Harvey (Posted: November 26, 2019)

quotes

Anecdote only

quotes

Reply

H. Jack West, MD (Posted: November 25, 2019)

quotes

Brigatinib is superior in efficacy compared to crizotinib, but the real comparison is currently alectinib, which is the standard of care today, after it demonstrated tremendous superiority compared to crizotinib in the ALEX trial.

Despite the encouraging PFS results of brigatinib in 2nd line trials after patients with ALK-positive NSCLC had progression demonstrated on critozinib, the ALTA-1 trial results looked no better with brigatinib than first line results with alectinib in a very similar population. Numerically, the PFS numbers were slightly worse -- not enough to say that it was a meaningfully worse choice than alectinib, but nothing at all to favor brigatinib over alectinib in this space.

Yes, fewer pills daily with brigatinib vs. alectinib, but if that's your leading feature, you're in trouble.

quotes

Reply

Dean Gesme MD FASCO (Posted: November 22, 2019)

quotes

A new standard of care for advanced HCC with OS Major survival advantage compared with standard oral sorafenib (HR 0.58)! Practice changing immediately with very good patient tolerability as well.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: November 19, 2019)

quotes

An oral option for primary hormonal therapy will be attractive for some patients, particularly those that are interested in intermittent therapy, more rapid testosterone recovery after stopping therapy, and rapid onset of action. Pricing, co-pays, and other practical considerations as well patient and physician preferences and habits will be important in defining the role of this new drug, if approved.

quotes

Reply

Thomas Marsland, MD (Posted: November 14, 2019)

quotes

More is not always better, and cheaper is not always the best value. We know that in the US drugs cost more than in many other countries. However using international pricing can be a very muddied water. There are several resolutions coming up at the upcoming interim AMA meeting in San Diego. One of the clear difficulties is in how one calculates the international pricing? Does it include all countries including those that have price fixing? Should it only include countries where prices are negotiated? What is the formula and how is it to be applied? As always we need to be VERY careful about unintended consequences. Our cancer patients are a very vulnerable population and even small changes in the system may have dire effects on their access to care. We all support reasonable cost effect pricing and care but we do have to be careful in making changes.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: November 11, 2019)

quotes

The VA serves substantial numbers of veterans living with prostate cancer, and offers unique opportunities for research advances through its large scale initiatives and integrated health care delivery model. The PCF's investment will complement the VAs commitment and make substantial contributions to veterans and to prostate cancer research.

quotes

Reply

John P Hanson Jr MD (Posted: November 01, 2019)

quotes

good idea

quotes

Reply

Thomas Marsland, MD (Posted: October 31, 2019)

quotes

Thank you ASCO.....This policy is critical in helping us in advocating for our patients who are being subjected to Copay Accumulator policies. This clearly is a way that those nasty non-transparent PBM's are shifting costs to the patients. If these policies gain widespread usage they will dramatically limit patient access to higher cost effective therapies. This policy now gives us something to take to our state and federal legislators to help limit these abuses. We now also have something to bring to our other professional organizations to request their assistance in limiting these types of programs.

quotes

Reply

H. Jack West, MD (Posted: October 29, 2019)

quotes

This development is very likely to prove to be too little, too late for altering first line treatment patterns in advanced NSCLC. The combination of nivolumab/ipilimumab in CheckMate-227 has just been reported to improve not only PFS but OS (Hellman, NEJM), so another anti-PD-L1/CTLA-4 combination that has had a checkered past, with many failures, and thus far has only demonstrated a PFS benefit is not compelling in a setting in which we already have more excellent treatments than we can pursue. As I've previously said, "You don't bring a knife to a gun fight, and you don't bring PFS to an OS fight."

This result provides a bit more confidence in tremelimumab, or at least keeps it from eroding further, but I would place good money on this combination having close to no impact on first line treatment patterns in advanced NSCLC.

quotes

Reply

H. Jack West, MD (Posted: October 24, 2019)

quotes

This will surely be an interesting trial to see the data on, but I suspect it will have little direct impact on treatment of patients with advanced NSCLC. Chemo/immunotherapy combinations based on KEYNOTE-189 (carbo/-pemetrexed/pembro) for non-squamous NSCLC or KEYNOTE-407 (carbo/taxane/pembro) for squamous NSCLC are already a strong standard of care, and either pembro monotherapy for selected patients (most appropriate for those with high tumor PD-L1 expression, based on KEYNOTE-024 trial) or now possibly nivo/ipi for others based on CheckMate-227 are available for those in whom a chemo-free option is preferred.

This 4 drug regimen beat an older standard of care that has already been improved upon with all of the regimens listed above, and we should expect it to have a more unfavorable side effect profile than any of these alternatives. Unless the data suggest it is strikingly superior to these other options, I think it will prove to have nothing to recommend it over an option that we already have (or are likely to have once nivo/ipi is approved based on the benefit observed in CM-227).

quotes

Reply

Debu Tripathy, MD (Posted: October 21, 2019)

quotes

This is a long-awaited landmark and registrational trial testing the HER2-specific kinase inhibitor tucatinib in the population of patients who have progressed on standard HER2-targeting therapies (pertuzumab/trastuzumab and T-DM1). It demonstrating an impressive 46% reduction in progression events and 34% reduction in death events. Currently used HER2 kinase inhibitors are not been as selective, also inhibiting HER1 (epidermal growth factor receptor [EGFR]), and therefore causing significant diarrhea as well as other side effects. Tucatinib-containing regimens are likely to become the standard 3rd-line therapy for the HER2 subtype of breast cancer that is associated with increasingly better survival, with many patients living more than 5-10+ years with advanced disease and being candidates for many sequential lines of therapy. Look for the integration of tucatinib in earlier lines of therapy and ultimately in early stage breast cancer.

quotes

Reply

Howard S. Hochster, MD (Posted: October 11, 2019)

quotes

Kudos to Dr Peter Bach on responding to PhRMA talking points on drug pricing. I am all for R&D and incentivizing the pharmaceutical industry. But that is the purpose of IP law and patent protection. This should not mean that the American taxpayer and insurance premium payers should subsidize the world by having unfettered pricing, at the same time that drugs are priced substantially lower in the rest of the world (through price negotiation at the time of drug approval). Congress enacted Medicare Part D with the caveat that no price negotiations be allowed. Now Congress must fix this problem, which is having major effects on health care costs and causing frequent personal financial toxicity.

quotes

Reply

Dean Gesme MD FACP FASCO (Posted: October 11, 2019)

quotes

Protein degradation has shown considerable efficacy in the form of proteasome inhibitors. Additional approaches to intracellular protein degradation holds considerable promise in the treatment of cancer and many other disease processes.

quotes

Reply

Thomas Marsland, MD (Posted: October 09, 2019)

quotes

Hmmmm....just read very interesting "Perspective" in NEJM (my light bathroom reading...) on Medicare drug negotiations. I must admit that that report and the associated one on redesigning Medicare D to control price burden did have some very interesting and provocative ideas. One that really turned me off however was the suggestion for an "independent" body to negotiate drug costs and pricing with Pharma with the use of "value" (QALY) as a determinant for the decisions on pricing and coverage. Gee...sounds like a US (not) NICER...if something like this were to become reality clearly access would be limited. We all need to pay close attention.

quotes

Reply

H. Jack West, MD (Posted: October 07, 2019)

quotes

Though the progression-free survival (PFS) for this global trial is very encouraging, we've seen other work out of Japan on erlotinib + VEGF inhibitor (bevacizumab previously) demonstrate a highly significant improvement in PFS that didn't translate into an improvement in overall survival (OS). I would say that based on the Japanese research, plus with the added burden of regular IV infusions added to an otherwise oral regimen, and the lack of CNS activity compared to the competing standard of osimertinib, I don't think this combination regimen will gain much traction in the absence of further follow-up demonstrating a significant OS benefit.

quotes

Reply

H. Jack West, MD (Posted: October 01, 2019)

quotes

The impact of the CheckMate-227 trial remains to be seen. While it was positive for an overall survival benefit, this was observed in the patients with PD-L1 expression 50%, but not in the patients with PD-L1 expression in between. This pattern doesn't give us a lot of confidence. At the same time, the OS benefit was compared to chemo alone, while the current standard of care is now chemo/pembro in most of these patients (certainly those with PD-L1 <1%), in whom there was a significant survival benefit seen in the KEYNOTE-189 and KEYNOTE-407 trials for patients with advanced non-squamous and squamous NSCLC, respectively. I expect that the appeal of a non-chemotherapy regimen will have some appeal to patients and oncologists, but we should recognize that non-chemo doesn't mean non-toxic. I expect that nivo/ipi will be a minor player compared to our current standards, likely used in <10% of patients in front line advanced NSCLC.

quotes

Reply

H. Jack West, MD (Posted: October 01, 2019)

quotes

An important result that should satisfy the holdouts who were waiting on a demonstrated improvement in overall survival while considering the potential utility of a sequential approach. The trial has a few flaws, most notably not requiring a baseline MRI and not requiring treatment of detected brain mets -- both factors that clearly benefit the osimertinib arm -- and the rate of subsequent therapies is conspicuously lower than expected. Nevertheless, the efficacy, tolerability, and CNS activity of osimertinib are all very favorable, and the biggest limitation in its global use is the aggressive pricing, which precludes its availability for many EGFR mutation-positive patients around the world and makes it a financial challenge for many of those who can access it.

quotes

Reply

H. Jack West, MD (Posted: October 01, 2019)

quotes

Overall, the results with immunotherapy for mesothelioma as presented at ESMO 2019 are quite disappointing. No improvement in progression-free survival or overall survival compared to nearly completely ineffective chemotherapy.

quotes

Reply

William McGivney, PhD (Posted: September 30, 2019)

quotes

I am somewhat “dazed and confused” by the article entitled “Why the Cancer Moonshot Has Been So Disappointing”. I guess the article should have been entitled “Why the Orphan Drug Designation Blocks the MoonShot!”. Making sure that I understood the definition of a cancer “death rate”: “the number of cancer deaths (the number of people who die from cancer) out of 100,000 people in one 1 year”, I can see that as one succeeds in prolonging survival one may not affect the death rate substantially in an aging population. Hence the statement in the article that “the cancer death rate has fallen only 5 percent since 1950” seems to be obscuring the significant gains from our scientific advances (improvements in survival). There is no question that public health measures such as no smoking have substantial effects. Next, the statement that the federal government has not exactly “invested large sums or directed research to focus on cancer” belies the fact that the federal government provides the 27 Institutes and Centers of the NIH with annual funding of $31.3 Billion of which $5.74 Billion (18.3 %) is allocated to the NCI. I guess the other Institutes might argue against the lack of investment in Cancer point. As I make my way through this article and meander through this commentary, things are becoming foggier and more obfuscated. I think it better (than meandering further) for the reader for me to close with two points. Firstly, in regard to Cancer drug/biologic development, the Orphan Drug Act might be viewed as “Prophetic” as the discovery of genomic aberrations and other biomarkers define target patient populations as being smaller and smaller. Secondly, the one clear statement in the article is that “curing cancer is an enormously difficult technical and medical problem”. It was good to find my way out of this article with one beacon of simple truth.

quotes

Reply

H. Jack West, MD (Posted: September 27, 2019)

quotes

With results largely echoing the findings of KEYNOTE-024 and KEYNOTE-042 trials in the PD-L1 high and broader PD-L1 positive populations, respectively, the IMpoower 110 trial represents a lateral move, at best, compared to pembrolizumab monotherapy. Notably, the favorable results with atezolizumab in the high PD-L1 group are partially from the benefit of no crossover, whereas the KEYNOTE-024 trial was highly positive for an OS benefit even with crossover built into the trial.

I would say that there is no reason to favor atezolizumab over pembrolizumab as monotherapy. The PD-L1 IHC test used in IMpower 110 is not widely used, and the clinical results provide no reason to deviate from the much more widely used standard of 22C3 testing and pembrolizumab monotherapy for high PD-L1 patients, while IO monotherapy remains a marginal if not clearly suboptimal choice relative to chemo/immunotherapy for patients with low tumor PD-L1 expression.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: September 27, 2019)

quotes

Real progress agains over-treatment in prostate cancer. And PSA, which has a bad name in the eyes of some, who have focused on its shortcomings in prostate cancer screening, comes to the rescue. PSA offers a sensitive early detection of recurrence which in turn enables early salvage radiation that appears to yield similar results to adjuvant therapy sparing many patients unnecessary therapy.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: September 27, 2019)

quotes

The trend that suggests the overall survival may be improved with therapy for nmCRPC is demonstrated again with more follow up. But, this is still not a statistically significant difference. Not a new finding.

quotes

Reply

Howard S. Hochster, MD (Posted: September 19, 2019)

quotes

Great data from SWOG on the influence of NCTN trials, both positive and negative. This confirms that large multi-center trials performed throughout a broad number of US oncology practices has the largest effect on how we practice oncology and state-of-the-art treatment. What is left unsaid is the contribution of the many practicing physicians who volunteer their very valuable time and even help support these underfunded studies to make them happen. Hats off to the cooperative group leadership, but an even BIGGER “hats off” to all those who participate. Please keep up the enthusiastic support !!

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: September 18, 2019)

quotes

Newly diagnosed metastatic prostate cancer requires combination therapy with LHRH agonist + a second agent. We now have four options. In addition to abiraterone and docetaxel, level I evidence supports apalutamide and enzalutamide. Choosing between these options is a practical challenge for oncologists.

quotes

Reply

William McGivney, PhD (Posted: September 17, 2019)

quotes

Any opportunity to limit the adverse effects associated with payer-driven, resource-wasting, patient-harming preauthorization requirements and review is important to take advantage of. The proposed federal legislation, Improving Seniors’ Timely Access to Care Act, represents one such opportunity. A key provision is the requirement for plans to report the “results” of their precertification processes. Plans will be required to report on the percentage of precert reviews that result in approvals. Also, importantly, plans must report on the percentage of precert denials that are reversed, overturned and approved. In the end, these statistics will show an egregious waste of time. More importantly, these statistics will show that such a waste of time, often delays treatment for patients whose cancers are progressing. Plans will be required to report on the length of time it takes to reach a final decision once a precert request is filed. One can be sure that an insurance company C-Suite executive would not stand for such delay or denial for themselves or a loved one. I know that from experience during my days at a major payer. Also, I have recounted the story here of a payer cardiology nurse (by training) lecturing a world-renown oncologist on what the NCCN Guidelines recommend. Being patient, the oncologist finally interpreted the NCCN Guideline recommendation for the cardiology nurse and closed by saying that she/he (the oncologist) was the Chairperson for that NCCN Guideline Panel. The key is for the 300 plus organizations supporting the bill to not relent until it passes and then to drive precertification processes further into the ground. For those working on this, I am happy to testify given my experience as VP for Coverage Policy at Aetna and service on the Medicare Coverage Advisory Committee.

quotes

Reply

H. Jack West, MD (Posted: September 17, 2019)

quotes

This is a very small trial that is subject to sensationalist treatment because it promotes an idea that is marketable, but the results are no more than provocative. They are clinically meaningless.

quotes

Reply

donsharpe (Posted: September 16, 2019)

quotes

Thank you for catching that Dr. Xu. We consulted with Dr. West and he agrees he made a mistake on that one. We have made the correction now. Thanks!

quotes

Reply

Bing Xu (Posted: September 13, 2019)

quotes

Dr. West, I guess you meant carbo/taxane with pembrolizumab (not pemetrexed) in your comment on IMpower131.

quotes

Reply

H. Jack West, MD (Posted: September 13, 2019)

quotes

Interesting retrospective work that finds profoundly worse outcomes in patients with any of several cancers (lung cancer most commonly) who received broad spectrum antibiotics in the month preceding start of immunotherapy. This work isn't sufficient to change management but supports a line of work that strongly suggests a meaningful association that needs to be studied further and may help us consider how to time the start of immunotherapy relative to antibiotic therapy that often precedes or is concurrent with initial workup of what ultimately proves to be advanced cancer.

quotes

Reply

Thomas Marsland, MD (Posted: September 11, 2019)

quotes

I have been doing this a long time, and one of the biggest frustrations I face today is the delay it takes to get patients the appropriate care they need. It didn't use to be that way. Prior auths are a big part of these delaying tactics foisted on us by the payer community. Hopefully this dysfunctional Congress can literally get this act together..... (comment from a long standing R). I would hope that in this bill that they also assure that those nasty PBM's also have to play by the new rules.

quotes

Reply

H. Jack West, MD (Posted: September 11, 2019)

quotes

Definitively answering a completely obviated clinical question.

quotes

Reply

H. Jack West, MD (Posted: September 11, 2019)

quotes

These results are not as impressive as those of KEYNOTE-407, so I would say that this trial will not lead to this regimen emerging as a strong alternative to carbo/taxane with pembrolizumab as the leading chemo/immunotherapy approach in the first line setting for patients with advanced squamous NSCLC. The absence of an OS benefit in this trial falls short of what we'd have hoped and would need to see to have this trial change practice.

quotes

Reply

H. Jack West, MD (Posted: September 11, 2019)

quotes

Impressive results overall, to me most notable for the sustained benefit in most patients who completed 2 years of pembrolizumab but stopped after that, suggesting that a 2 year duration is appropriate, then stopping, rather than continuing it indefinitely. In addition, the fact that most patients who had subsequent progression responded again upon re-challenge was reassuring.

For me, the leading disappointment was that only 65% of those patients assigned to initial chemotherapy crossed over to receive pembrolizumab on progression. It's regrettable that 1/3 of an enriched population of patients who are relatively likely to demonstrate a dramatic and prolonged benefit from immunotherapy missed that opportunity. It underscores the value in having patients receive the best treatment for them early on, given the risk of attrition from one line of therapy to the next.

quotes

Reply

H. Jack West, MD (Posted: September 06, 2019)

quotes

The approval of the IMpower133 regimen (carbo/etoposide/atezolizumab) should represent a new standard of care for first line extensive stage SCLC in Europe, though the results of the CASPIAN trial (cisplatin or carboplatin with etoposide, +/- durvalumab) that are being presented at the World Conference on Lung Cancer in Barcelona in a few days will likely be an alternative if approved.

The IMpower130 regimen of carbo/nab-paclitaxel/atezolizumab for non-squamous NSCLC won't displace the KEYNOTE-189 regimen (cis or carbo + pemetrexed + pembrolizumab), but it's an alternative that will be of some use for patients who aren't candidates for pemetrexed due to poor renal function, severe rash with pemetrexed, or some other uncommon situations.

quotes

Reply

H. Jack West, MD (Posted: September 06, 2019)

quotes

This is a very active, well tolerated agent that will be a welcome option once FDA approved for MET exon 14 mutation-positive NSCLC.

quotes

Reply

Dean Gesme, MD (Posted: September 03, 2019)

quotes

KRAS is a ubiquitous and mouth-watering target for drug developers. Amgen’s AMG 510 Phase 1 response data looks highly encouraging although we have been down this road too often to overcome prudent skepticism until far more mature information from additional larger trials becomes available.

quotes

Reply

H. Jack West, MD (Posted: August 21, 2019)

quotes

Disappointing but not surprising. Despite the recent press release about CheckMate 227 results showing nivo/ipi beating chemo alone in first line NSCLC, the combination doesn't come close to deserving to displace the chemo/pembro combinations or pembro monotherapy that have handily beaten chemo already and are the current standards of care. And nivo/ipi has at least had some positive traction, while durva/treme has failed in every lung cancer setting in which it has been studied.

The durva/treme regimen deserves to be relegated to "asked and answered" status in lung cancer research. It has failed every way it can. In the process, it has only dampened enthusiasm for the concept of IO combinations and the potential benefit of TMB in clinical decision making, concepts that are on the cusp of being integrated at least into the margins of practice but are more questionable with the release of these findings.

quotes

Reply

Thomas Marsland, MD (Posted: August 20, 2019)

quotes

It is rare that I comment on a "clinical" report as opposed to one more tied into regulatory or business aspects of practice. But partially to prove that I really do read the clinical report I thought I would comment on this one. What intrigued me about this is the fact that it is real world data. While clearly on "practice changing" this report does show how real world data has the potential to impact clinical practice. One might like to know how the data has been screened since it is collected from multiple sites on a given emr (?? which one). For these types of reports to be valid it is important to understand how the data is collected and scrubbed. Obviously the randomized trial is the gold standard but as this report demonstrates not every clinical situation can be reproduced in a randomized study.

quotes

Reply

H. Jack West, MD (Posted: August 20, 2019)

quotes

If FDA approved, lurbinectedin will emerge as a compelling alternative to topotecan, which remains one of the least favored standards of care in oncology. Many will still be holding out for randomized data with lurbinectedin, which should be provided in the ATLANTIS trial, which is looking at lurbinectedin with doxorubicin. If that trial is positive, I suspect that most people will actually favor using lurbinectedin as a single agent, given the additive myelotoxicity of these agents.

quotes

Reply

H. Jack West, MD (Posted: August 19, 2019)

quotes

Sad that we live in a world in which a drug priced at $17K a month is being portrayed as a bargain.

quotes

Reply

H. Jack West, MD (Posted: August 16, 2019)

quotes

Another remarkably active drug for these small subsets of patients.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: August 14, 2019)

quotes

Cardiovascular complications are increased in patients treated with modern hormonal agents when compared to similar patients treated with placebo. Here, the authors confirm that cardiovascular mortality is higher in patients with pre-existing cardiovascular conditions. These impacts are relative small and overwhelmed by the survival advantage that these drugs offer through their effects on cancer, but in individual patients, the risk/benefit calculation regarding treatment needs to be informed by an understanding of these risks.

quotes

Reply

Howard S. Hochster, MD (Posted: August 14, 2019)

quotes

Congratulations to Dr von Mehren and her colleagues on a highly positive study of Ripretinib in refractory GIST. With a HR of 0.15 compared to placebo the drug is truly beneficial. But how long will we continue to see studies of new drugs vs placebo in late line settings? This strategy is getting FDA approvals, but perhaps not advancing treatment. I look forward to seeing this agent compared to imatinib in the first line setting. This might lead to real progress.

quotes

Reply

H. Jack West, MD (Posted: August 09, 2019)

quotes

An important and unsurprising result after seeing the immature but encouraging survival curves presented at ESMO 2017, this OS benefit crystallizes osimertinib as first line standard of care with superior efficacy, better tolerability, and the best CNS activity/control among EGFR TKIs. However, it will be worth paying attention to what proportion of patients received subsequent therapies, because if the majority of patients on this global trial never received treatment beyond their first line treatment assignment, FLAURA will confound variables of first line osimertinib and overall optimal treatment of EGFR mutation-positive patients over time. In the US and many other health care systems, EGFR mutation-positive patients get several lines of therapy over many years, as they tend to have modest progression at a time of acquired resistance and should still be candidates for subsequent systemic therapies. If that isn't happening for the majority of patients, it should call into question the health care system that is delivering such a low quality of care.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: August 07, 2019)

quotes

If approved, olaparib will be the first drug specifically for prostate cancer that would be prescribed based on the presence of specific mutations, bringing precision oncology to patients with this common malignancy. We will await the actual results, of course, to fully understand olaparib's potential.

quotes

Reply

H. Jack West, MD (Posted: August 07, 2019)

quotes

This analysis showed that these hospitals affiliated with top cancer centers actually had better outcomes even before the affiliation. This suggests that the better community hospitals became affiliated with a top-ranked cancer center because they provided better care, rather than that the affiliation led to better outcomes at the community-based hospitals.

quotes

Reply

Howard S. Hochster, MD (Posted: August 07, 2019)

quotes

It is reassuring to know that the Guardant 360 blood test can predict patients whose tumors have microsatellite instability with very high accuracy. This may eliminate the need to re-biopsy some patients were tissue is not available or if one is unable to retrieve the blocks for easily performed IHC testing. However the real value of the Guardant 360 is detecting low levels of mutated tumor DNA in the adjuvant treatment setting when we will be able to tell our patients they are in molecular remission. This page, taken from the myeloma playbook, will be a real option with a few more years of data accumulation. The NCTN investigators are currently planning human trials in colon cancer adjuvant therapy in both stages 2 and 3, guided by circulating tumor DNA results. Coming soon for your participation.

quotes

Reply

Dean Gesme, MD (Posted: August 06, 2019)

quotes

Including patient assistance funding provided by manufacturers directly to patients in ASP pricing would produce many possible "unintended consequences" at a time when cancer patients deserve greater transparency rather than more obstacles and perverse incentives.

quotes

Reply

Debu Tripathy, MD (Posted: August 03, 2019)

quotes

Liquid biopsies have been shown to be as good as tumor biopsies in analyzing gene mutations that can be targeted with appropriate biological drugs in advanced cancers. Now, this technology is being expanded to detect minute amounts of tumor DNA in early stage patients who may be destined to relapse. Larger studies are now confirming that these tests are accurate, but certainly not perfect. The critical question is whether this lead time can translate into timely therapies that can prevent or significant delay recurrences to the point that more cures or longer/better lives can result - such studies are now being planned.

quotes

Reply

H. Jack West, MD (Posted: August 02, 2019)

quotes

It’s important to note that this is significant cherry picking, and the numbers shouldn’t be compared to other state in EGFR mutation-positive patients. This is looking at results for an enriched population of patients who were selected for the best opportunity for doing extremely well.

These results are of some value as a proof of principle but don’t have a true, inclusive denominator of all of the patients who started on afatinib, including the many who didn’t receive subsequent osimertinib, as other data with first or second generation EGFR TKIs are conventionally presented.

quotes

Reply

(Posted: August 02, 2019)

quotes

This is a very "political" and misleading article that is a slap-in-the-face to physicians who offer intravenous iron (for far less money). There are many patient who have symptomatic iron deficiency anemia who improve reliable and fully by getting intravenous iron, in a setting where oral iron is not reliable and causes severe, daily side effects.

quotes

Reply

Desn Gesme (Posted: August 01, 2019)

quotes

Incredible new targeted therapies in CLL and lymphoma are fantastic— but the Holy Grail will be identifying time limited therapeutics which balance safety and efficacy with total cost over time!

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: August 01, 2019)

quotes

Darolutamide is the third agent approved in non-metastatic CRPC in a short time. This disease state had no approved therapies until quite recently. Clinicians will now have to choose one of these three similar agents for their patient with enzalutamide being most familiar and darolutamide claiming a potential advantage with regard to adverse effects.

quotes

Reply

Debu Tripathy, MD (Posted: July 31, 2019)

quotes

In a short period of time, three randomized trials have reported emerging survival benefits with the addition of cyclin-dependent kinase (CDK) 4/6 inhibitors to endocrine therapy. Given the large benefits in progression-free survival, roughly a doubling seen with these agents, it was puzzling that early on, improvements in survival were not seen. But with longer follow-up, thankfully, these drugs appear to have achieved what many consider the gold standard for a treatment outcome that is truly clinically meaningful. Of course, with improvements in quality of life already demonstrated and with reasonable safety profiles, these drugs have become a common component of first and second line therapy in this population of patients – specifically those with advanced hormone receptor-positive and HER2-negative breast cancer. Of the three approved CDK inhibitors so far, ribociclib and abemaciclib have shown prolongations in survival, and palbociclib also has shown this trend, with survival analyses on these trials still pending. These findings will clear the way for approval in other countries and will also likely increase the percentage of patients treated these agents. We hope to learn more about how to build on these successes, such as using rational drug combinations that augment these benefits.

quotes

Reply

Debu Tripathy, MD (Posted: July 30, 2019)

quotes

This is now the second trial with a CDK 4/6 inhibitor to show a survival benefit in patients with advanced hormone receptor-positive and HER2-negative breast cancer. MONARCH-2, a trial testing abemaciclib (Verzenio) in the second line setting in combination with fulvestrant now joins MONALEESA-7 - a first line trial testing ribociclib (Kysqali) with endocrine therapy in pre-menopausal women in showing a survival difference. The actual magnitude of the difference was not stated in the press release, but this finding bodes well for the overall strategy of using this class of agents. CDK inhibitors are now being tested in other subtypes of breast cancer as well as other malignancies and are also being evaluated as adjuvant therapy for early stage breast cancer. Still, resistance to these drugs needs to be better understood to keep the trend going for longer lifespans with metastatic breast cancer.

quotes

Reply

Debu Tripathy, MD (Posted: July 29, 2019)

quotes

This is clearly an important advance in the field of immunology for breast cancer, where improvements in outcome have been slow in coming. Following early positive results from the I-SPY 2 trial, where pembrolizumab improved the pCR rate when added to standard chemotherapy, the KEYNOTE-522 trial now definitively shows an improvement in this endpoint in triple negative breast cancer. In this subtype, an improved pCR translates into a good chance that there will be a favorable impact in recurrence and survival. Much of this depends on the final data in terms of the magnitude of the difference in pCR rate attributable to pembrolizumab. This trial was also powered to assess event-free survival as a co-primary endpoint, with over 1000 participants randomized, so these results are eagerly awaited, although at least a couple of years away.

quotes

Reply

(Posted: July 16, 2019)

quotes

Antibody drug conjugates (ADCs) may be the next "Big Thing" while breakthroughs in cellular therapies and combination I/Os move slowly and incrementally forward for solid tumors.

quotes

Reply

H. Jack West, MD (Posted: July 15, 2019)

quotes

I would think Orphan Drug Designation would be more applicable in a situation in which we don't already have a chemo/immunotherapy combination approved in the last year based on a significant survival benefit in the exact same indication -- but who can figure out the FDA?

Did I miss an announcement that they're working with the pharma industry to offer an employee incentive program based on number of new approvals, regardless of actual need?

quotes

Reply

Thomas Marsland, MD (Posted: July 12, 2019)

quotes

COA absolutely has it right on this proposal. Mandatory participation in these proposed payment models is a non-starter for the medical community. We all support innovative programs to improve quality and cost but mandating unproven programs that potentially have dramatic effects on clinical practice and possibly effecting access to care is not acceptable. These programs should be small pilot to confirm "proof of principle" and voluntary. This is also a potential problem for the possible CAP program again being looked at for medical oncology. COA got it right !!!

quotes

Reply

(Posted: July 12, 2019)

quotes

Good insight, communication up front is the best way to assist patients with their financial responsibility and options available to help them.

quotes

Reply

(Posted: July 10, 2019)

quotes

yippee

quotes

Reply

Thomas Marsland, MD (Posted: July 09, 2019)

quotes

As we all know the gold standard will always be the clinical trial, however it is exciting to see the growth of real world data/evidence into the practice of oncology. There are two key factors that will help with the growing use of RWD. First, there are clinical trials that will never be done ie looking into differences in efficacy and toxicity in the same class of drugs will be helpful in determining if a specific drug may have therapeutic benefits in a given class (and if not perhaps cost advantages may drive decision making). Also, in real world practice we see many patients that would never make it into a clinical trial due to age, co-morbid conditions or other factors. Having a base of knowledge on how these patients respond to a given therapy would be priceless in helping to decide what treatment would be beneficial in these clinical situations. Clearly the vendors need to be well vetted in how the data are accumulated and scrubbed to assure that it is accurate and valid. Kudos to FDA for starting to evaluate the role of RWD and its application to clinical practice.

quotes

Reply

Thomas Marsland, MD (Posted: July 03, 2019)

quotes

Having lived in both the private practice, buy and bill system, and now as an employed physician in a 340B hospital system, drug profits are always in the discussion regardless of the system. Clearly we choose the most effective, least toxic drug as appropriate for the patient. As to generics, we tend to use them where they are available. Similarly until recently there really has been very limited use of biosimilars. As more become available the use will increase. In our system we are definitely moving in that direction (revenues are part of the driving force in that movement). So drug profits will always be on the table, the question is who makes the profit. Systems are now also making economic decisions on what products to use regardless of how the oncologist gets paid.

quotes

Reply

H. Jack West, MD (Posted: July 02, 2019)

quotes

These results are impressive and echo the results we have already seen from NLST, and more recently from NELSON (though the latter remains unpublished). The data should be overwhelmingly convincing in leading to broad chest CT screening for eligible patients in the age range and with a sufficient smoking history. It is a terrible disservice to patients that lung cancer screening is pursued in only a small minority of the appropriate screening population. We are missing an opportunity to save thousands of lives.

quotes

Reply

H. Jack West, MD (Posted: June 27, 2019)

quotes

An important trial result that is very similar in trial design to the IMpower133 trial of carbo/etoposide with either atezolizumab or placebo, CASPIAN also shows a significant survival benefit of platinum-based chemo (presumably cisplatin or carbo at physician discretion) with durvalumab. Because this is essentially the same finding as in IMpower133, the key issue will be whether the efficacy with durvalumab appears more impressive. There is clear room for improvement on the IMpower133 result, which showed a 2 month improvement in median overall survival (and hazard ratio of 0.7) that was sufficient to change the standard of care from chemo alone but didn't blow away the lung cancer community. We await the presented/published results of the CASPIAN trial.

Also notable was the lack of mention of outcomes with durvalumab/tremelimumab combination with chemo, which presumably means it will again prove disappointing in a new lung cancer setting.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: June 26, 2019)

quotes

It would be best if enthusiastic titles like this one appeared after and not before a medical advance is made, verified, and implemented. This test may indeed represent a significant advance. But we have way too many promising headlines and way too few effective tests.

quotes

Reply

(Posted: June 25, 2019)

quotes

We have to understand the snps and mutations with their pathways and proteins before we can comprehensively recommend epigenetic rescues. Or work like crazy to gene splice and repair the defects. More organized research needed!

quotes

Reply

Howard S. Hochster, MD (Posted: June 24, 2019)

quotes

It is clear that anti-PD(L)1 drugs have benefit for some patients with HCC. But the perspective that these data are from relatively small trials of heavily pre-selected patients, who have managed to survive beyond first-line sorafenib, has been lost in the enthusiasm of bringing immuno-therapy to all patients. The stakes are high and this first randomized trial of nivolumab vs sorafenib again demonstrates the complexity of patient selection (or lack thereof). In more than 1000 first-line patients randomized, nivolumab was not statistically superior to sorafenib, though it came quite close. Again better selection of appropriate patients would have made this a positive trial, and we may yet see this in the future. In the meantime, multiple other trials of anti-PD1 and TKIs vs sorafenib (ImBRAVE, COSMIC, etc) are well underway. These results can only temper our expectations.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: June 20, 2019)

quotes

The is a small study, so additional experiments are needed, but it is a very interesting finding because in general we think about environmental carcinogens as inducing damage to the DNA and causing cancer directly rather than through effects on the immune system. If confirmed, these findings may have broader implications about how our environment can contribute to cancer development.

quotes

Reply

H. Jack West, MD (Posted: June 18, 2019)

quotes

This approval should be obviated by integration of atezolizumab with chemotherapy as first line treatment for extensive stage small cell lung cancer based on the survival benefit of the IMpower133 trial. The data supporting this approval are relatively unimpressive. This is an approval the lung cancer community doesn't really need, and it's based on a clearly lower standard for approving this, nivo in the SCLC space, etc.

It will be a shame to have oncologists giving pembro (or nivo) after patients have progressed on chemo/atezo first line for extensive stage SCLC, but I fear that will happen far too often, with no data, a very weak rationale, and at a remarkably high cost for such a wasteful and unjustified (mis)use.

quotes

Reply

Howard S. Hochster, MD (Posted: June 18, 2019)

quotes

For patients with germline BRCA mutations, the risk of many cancers and including breast, ovarian and pancreatic cancer are quite elevated. These tumors are sensitive to platinum based chemotherapy, and the option to use PARP inhibitors, such as olaparib, as maintenance maintenance provides a relatively non-toxic treatment option for these patients. This was also shown in the POLO study for BRCA-related pancreatic cancer with a more than doubling in PFS on maintenance. Some patients responded further by scan and these had median benefit of more than 2 years. The challenge is to extend this finding to other platinum sensitive tumors with DNA Damage Repair defects and to extend the use of these agents to more patients.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: June 10, 2019)

quotes

Body fat distribution is increasingly recognized as a distinct factor in health. Studies are needed to establish approaches to moderate the risks that we are now discovering.

quotes

Reply

Dean Gesme, MD (Posted: June 06, 2019)

quotes

We wait with bated breath each spring to see what new drug updates will be announced at ASCO with often outrageous pricing decisions. All the while, we have existing simple tools at our fingertips to greatly alleviate suffering and improve quality of life for our patients - e.g. end of life planning. Payers, patients and providers should be implementing these simple low cost strategies as a very high priority while also integrating high tech, high cost approaches for those who may qualify.

quotes

Reply

H. Jack West, MD (Posted: June 05, 2019)

quotes

While in keeping with what we see informally in our clinics, these documented results from primarily previously treated patients a trial setting highlight the amazing advance that PD1/PD-L1 directed immunotherapy represents in NSCLC. We are seeing a significant minority of our patients alive 5 years out from starting a salvage therapy, and even 25% of patients with high tumor PD-L1 (50% or higher); many are without evidence of active disease. It is truly remarkable, though the fact that there are clear differences based on PD-L1 expression highlight that there are still some patients who are much more or less likely to be major beneficiaries.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: June 01, 2019)

quotes

The TITAN study adds apalutamide to a growing number of agents that improve outcomes in metastatic prostate cancer. It is now crystal clear that the first treatment for metastatic prostate cancer must include more than standard hormonal agents like leuprolide. Which agent to add, be it apalutamide, enzalutamide, abiraterone, or docetaxel, is a decision each patient and their oncologist will make. But conventional ADT alone is clearly inferior.

quotes

Reply

Debu Tripathy, MD (Posted: May 30, 2019)

quotes

The PI3 kinase pathway is difficult to target as it is the superhighway to essential functions including cell growth, metabolic activity and even immunity. These pathways converge, diverge and exhibit “short circuits” that can be adapted to bypass pharmacological blockade. Yet there is now doubt that this pathway is dysregulated in cancer with numerous activating mutations as well as a loss of function alterations in the dampening components of this pathway. Many of these adaptive changes are not even occurring at the genomic level and are being uncovered though more sophisticated assays that reveal epigenetic or post-translational mechanisms.

This is evident in the recent approval of the first mutation-directed therapy for breast cancer. The study did meet its pre-specified endpoint of improving progression-free survival by over 5 months (HR 0.65). Both the efficacy and reciprocal side effects demonstrate challenges in targeting this pathway. The inability to fully isolate the oncogenic from the normal function signals result in incomplete effects as well as “off target” and “on target” toxicities, which are clearly of greater extent in general compared to CDK 4/6 inhibition. The alpha isoform-selective PI3K inhibitor alpelisib is relevant to hormone receptor-positive and HER2-negative breast cancer, where activating mutations in the alpha catalytic subunit (PIK3CA) are common. Using an selective drugs in patients with demonstrated mechanisms of activation of PI3K pathway is an important step forward, and had been clearly demonstrated in the SOLAR-1 trial. Combinations with other endocrine therapies is underway, and methods to mitigate toxicities, particularly hyperglycemia and gastrointestinal symptoms are being evaluated. This field will clearly grow, as innovations refine the approach and improve the therapeutic index.

quotes

Reply

Howard S. Hochster, MD (Posted: May 22, 2019)

quotes

In a long expected result, the 2nd-3rd line BEACON trial of encorafenib and binimetinib (with or without cetuximab) compared with the standard Irinotecan and cetuximab, in a 3-arm randomized trial (N=663) showed the benefit of these improved BRAF and MEK inhibitors for BRAF-mutated mCRC. These newer generation signal transduction inhibitors were expected to show improved outcomes compared with earlier inhibitors, based on prior results. The triplet showed improved RR (26 vs . 19%) compared with the standard arm and OS (9.0 vs 5.4 months), both reaching statistical significance. The triplet was better than the doublet but this did not reach statistical significance. Both of these kinase inhibitors are already approved for melanoma, and fall within the NCCN guidelines. This regimen should be considered a standard for the 8% of mCRC with BRAF mutation, following FOLFOX first line therapy. Another option is irinotecan, cetuximab and vemurafenib as shown in the S1406 trial, also chaired by Scott Kopetz. While a small subset of mCRC, this is the first "all biologic" combination therapy in CRC and a great step forward for patient therapy.

quotes

Reply

(Posted: May 17, 2019)

quotes

Trastuzumab deruxtecan makes Margetixumab clinically irrelevant

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: May 14, 2019)

quotes

While it is undoubtedly exciting to find that more than half of the men with advanced prostate cancer have a genomic alteration which we may be able to match to a drug, this is a very long way indeed from demonstrating a patient benefit. There are countless examples of targeted drugs that yielded little or no benefit in prostate cancer and many other malignancies. This is an important first step, but what is needed next are careful studies that demonstrate what drugs can help which patients based on genomic findings. The routine use of such approaches outside of a clinical trial is not yet warranted with some very specific and not common exceptions. This is not yet an argument for molecularly directed therapy for more than half of our patients.

quotes

Reply

Debu Tripathy, MD (Posted: May 08, 2019)

quotes

The development of testing of new antibody-drug conjugates (ADCs, also known as immunoconjugates) is rapidly growing as these agents allow for more cancer cell-specific drug delivery and the use of more potent cytotoxic drugs than can be given by conventional administration. Every such drug has its own "operating characteristics" depending on the antibody/antigen system used, the nature of the linker attaching the antibody to the active drug and the cytotoxic "payload". In the case of trastuzumab deruxtecan, impressive response rates were shown in pretreated patients with HER2+ breast cancer the Phase I setting. Responses nearing 50% were even shown in a separate cohort of patients who had lower HER2 expression in the negative range by conventional definitions. While the results of the Phase II trial have not yet been made public, there is significant enthusiasm as the Phase III registration trials for both HER2+ and HER2-low get off the ground.

quotes

Reply

Dean Gesme, MD (Posted: May 08, 2019)

quotes

The expansion of antibody drug conjugates may have more "real world" benefit for our patients than CART cells. We are also in need of expanding our anti-Her2 breast cancer armamentarium and this agent may prove active in IHC 1+ breast cancers as well!

quotes

Reply

Debu Tripathy, MD (Posted: May 07, 2019)

quotes

The approval of T-DM1 (ado trastuzumab emtansine) in the adjuvant setting for patients who have residual disease after standard neoadjuvant (pre-operative) therapy for HER2+ breast cancer is a breakthrough for two very important reasons. First, it has a large effect - cutting recurrence risk by 50% in a high-risk group of patients. That alone is a notable achievement. However, in a larger sense, it establishes that pre-operative therapy is not only a treatment that might help shrink breast cancers in order to allow for less aggressive surgery (eg. breast-conserving surgery), but that it is actually a "bioassay" that helps determine which treatment after surgery is most effective. While we have long been using pre-operative therapy as a way to potentially personalize treatment, this is the first actual demonstration that we can put this theory into practice. We are going to see further advances in "precision" medicine by real-time monitoring during treatment to determine what the best next step is for each unique case, and to accelerate the testing of new therapies using this platform. So while the practical result for now is the approval of an established drug in the advanced setting for a new indication in early stage setting - it has much broader implications going forward.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: May 06, 2019)

quotes

Studies of large populations have inherent limitations in their ability to account for confounders, so it is hard to be sure if hormone therapy really increases risk of dementia. And the story of hormones and dementia in general is complex. Research that directly addresses this question is needed. It is less clear that this information is sufficiently robust to use in treatment discussions and decisions.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: May 02, 2019)

quotes

The additional of hormonal therapy to radiation in the salvage (rising PSA post prostatectomy setting is the new and impactful change to these practice guidelines. Clinicians should be aware of the potential benefits of adding hormonal therapy in this setting, and of the toxicities.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: April 29, 2019)

quotes

Darolutamide would be the third androgen receptor inhibitor for non-metastatic castration resistant prostate cancer if it gains approval. The improvement in metastases-free survival with these agents is substantial, although it is too early to know how that effect translates into overall survival results. It is interesting to observe that Priority Review was granted even when two existing agents are already approved in this disease state.

quotes

Reply

Tomasz M. Beer (Posted: April 18, 2019)

quotes

Exciting to see the ARCHES clinical trial selected for the plenary session. We learned in February that the trial was positive and showed improvements in progression-free survival from enzalutamide added to hormonal therapy in newly diagnosed metastatic prostate cancer. More information will be helpful in putting these results in context of the previously known benefits of abiraterone and docetaxel in the same setting.

quotes

Reply

H. Jack West, MD (Posted: April 12, 2019)

quotes

This new approval is more likely to lead to worse care rather than net benefit. The approval of pembrolizumab for patients with a lower threshold tumor PD-L1 of 1% is based on the KEYNOTE-042 trial being positive against chemo doublet alone in this broader population. However, pembrolizumab was already approved for patients with high PD-L1 of 50% of greater, and that group was the one that drove the positive results of the trial overall, essentially "carrying" the group with tumor PD-L1 1-49%, who did no better with pembro monotherapy than with doublet chemotherapy. The trial was positive despite having favorable results with pembro from the high PD-L1 group diluted by the extremely weak results with pembro monotherapy for the low PD-L1 group.

Some will say that the fact that the first line pembrolizumab arm did just as well in overall survival as doublet chemo means that this now makes pembrolizumab a viable alternative. That might be the case except that the chemo alone arm was not permitted to cross over to immunotherapy upon progression, which has been a well established standard of care for years in patients with advanced NSCLC and who progressed after first line chemotherapy. The first line pembro arm only did as well as a hobbled, substandard of care arm that started with chemo and couldn't get subsequent immunotherapy. On the other hand, every patient who started on pembro could easily transition to chemo later.

Finally, the inclusion of patients with stage III NSCLC who are not able to get chemo/radiation is another concern, since the current standard of care in this setting, chemoradiation followed by durvalumab, is a potentially curative therapy. These were not patients who were the planned subjects of KEYNOTE-042. For patients with stage III NSCLC to receive single agent pembrolizumab rather than chemoradiation would be an egregious affront to our best data-driven standards.

quotes

Reply

Ted Okon (Posted: April 11, 2019)

quotes

PBMs are getting more brazen in how they delay and deny cancer patients their oral drugs. Anyone in practice knows that. The Senate Finance hearing was a necessary first step but a lot more needs to be done — especially focusing on how PBMs are adversely impacting patient care.

quotes

Reply

Parity of Medicare Reimbursement is needed (Posted: April 11, 2019)

quotes

When the Medicare fee schedule pays the same for clinic-based as well as hospital-based services, that will be a good first step in improving rural access to care. Free-standing satellite oncology clinics cannot remain open when they are forced by CMS to bill as clinic-based operation. It doesn't pay for the drugs. 340(b) doesn't apply to satellite operations, when the "mother ship" institution is not in a 340(b) zip code.

quotes

Reply

H. Jack West, MD (Posted: April 11, 2019)

quotes

A disappointing failure, but one that at least leaves the new standard of first line carbo/etoposide/atezolizumab, which showed a survival benefit over chemo alone in the IMpower133 trial, as an uncontested leading approach today. Surprising to see such weak results even for the nivolumab/ipilumumab doublet, but the fact that there's a suggested benefit on the far right end of the curve highlights that there is a subgroup who do well with immunotherapy -- we just need to figure out how to identify them prospectively.

quotes

Reply

Howard Sandler, MD, MS, FASTRO (Posted: April 08, 2019)

quotes

Some of the leaders in the US from UCLA and UCSF report on their Ga68 PSMA PET scan results in prostate cancer patients after surgery, after RT or after both. While PSMA PET has not been formally compared with fluciclovine PET, many expect PSMA PET to be superior imaging modality. Hopefully, we'll see some high quality comparison data and hopefully we'll have access to an FDA-cleared PSMA imaging modality soon.

quotes

Reply

Howard S. Hochster, MD (Posted: April 08, 2019)

quotes

Thanks to the FDA for this initiative. Underscoring once again that there is nothing "medical" about "medical marijuana," those seeking financial benefit have turned CBD into 21st century snake oil. Claims of its benefit far exceed the small amount of medical evidence for seizures and are based on anecdotal evidence. We need appropriately conducted controlled clinical trials to determine the medical benefits of both marijuana and CBD. Government support and lowering of barriers to conducting this research are necessary.

quotes

Reply

Debu Tripathy, MD (Posted: April 06, 2019)

quotes

This label approval of palbociclib for male breast cancer is an example of creativity to address subsets of patients rarely represented in clinical trials, yet for whom it is plausible that the results may not reflect the main study findings. This subsets typically include males (in the field of breast cancer) as well as older patients, pediatric patients or those with varying degrees of organ dysfunction. Small trials used to be required to extend the label to these subsets (although often physicians would just their own judgment, but then may get challenged by insurance companies. This approval is interesting in that it is based on part on new sources of "real-world" data, large data aggregators like Flatiron Health, where outcomes are analyzed based on "big data", including electronic medical records in some cases. We may see more of this - in fact, it is possible that clinical research for some of the less complex diseases will migrate to being primarily conducted in this environment.

quotes

Reply

H. Jack West, MD (Posted: April 03, 2019)

quotes

Nice to see further long-term survival data, really in keeping with what we've seen up to now. There are a significant minority of patients who continue to demonstrate prolonged survival far beyond what we'd seen before the era of immune checkpoint inhibitor therapy in advanced NSCLC. That said, the world has shifted to using immunotherapy agents primarily first line in advanced NSCLC. These data don't suggest any change in management or our thinking.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: April 02, 2019)

quotes

A badly misleading title. This study could not determine if survival is prolonged by the combination. The only thing that this trial can demonstrate is that the combination tested is tolerable and feasible. It will be interesting to see it move beyond phase I. But for now, we know it is feasible.

quotes

Reply

Thomas Marsland, MD (Posted: April 01, 2019)

quotes

This particular article hit close to home on two fronts. I can share the author's frustration about primary care since I have recently had to go through the experience of "changing my primary." I received multiple letters from several different entities claiming to be my insurer, completely unclear who the actual insurer is. These letters offer several different panels and availability. Clear as mud as they say. Now also from the side of doctor providing care, I am extremely frustrated by ongoing delays experienced by my patients when I try to refer to another provider for additional insights, and learn that often they are given the "next available " appointment many times months away. Clearly that does not result in good quality care. Usually I can short circuit this with a personal phone call (begging) my colleague to see if they could possibly get my patient is a little sooner (and again to my frustration it usually isn't just one phone call but multiple episodes of phone tag).... texting is somewhat quicker but again often don't have the doc's personal cell and even then am limited by privacy concerns about what I can actually say in a text...)

quotes

Reply

Thomas Marsland, MD (Posted: April 01, 2019)

quotes

Although certainly onerous non-competes have been around for a long time. Also over the years I have labored in numerous different programs and systems and they all expect you to "support the team." The critical issues are whether personal compensation becomes a factor in driving referrals. When it does that could ultimately result in reduced access to care for some patients.

quotes

Reply

thomas marsland (Posted: April 01, 2019)

quotes

Oral parity has been an issue for a long time. Clearly this needs to be done correctly. We don't want to have the higher patient costs seen on the pharmacy benefit side transitioned to the medical benefit side where most chemotherapy drugs presently reside. Making this more complicated is the move by the administration to consider moving more Part B benefit drugs to the Part D coverage program. How would those moves effect the "parity" issue when Part D becomes the primary coverage for more cancer drugs?

quotes

Reply

H. Jack West, MD (Posted: April 01, 2019)

quotes

These data are really obviated by the new standard of carbo/etoposide with atezolizumab as first line treatment for extensive stage SCLC. It is difficult to impossible to see how these data would be relevant with patients with extensive stage SCLC routinely receiving first line atezolizumab. There is no reason to think that subsequent pembrolizumab would have any activity in this setting.

quotes

Reply

H. Jack West, MD (Posted: March 25, 2019)

quotes

This was expected based on prior, preliminary presentation of data from this study, though every bit of positive results in small cell lung cancer (SCLC), particularly relapsed SCLC, is very welcome. Lurbinectedin has demonstrated good evidence of activity as a single agent or combined with doxorubicin, though single agent appears to have the better therapeutic index. Still, we await the results of phase III data with lurbinectedin before we can really establish a place for this agent in the management of patients with relapsed SCLC.

quotes

Reply

H. Jack West, MD (Posted: March 19, 2019)

quotes

This is an important and appropriate FDA approval. Though the improvement in median overall survival in IMpower133 was a relatively underwhelming 2 months (at least underwhelming by recent standards set with immunotherapy and targeted therapies), the hazard ratio is 0.7, and the beneficiaries have generally achieved prolonged benefit. This approach is a statistically and clinically significant benefit for a broad population with extensive stage SCLC and represents what should be considered the new standard of care, at least until we get a better sense of how to clarify prospectively which patients with extensive stage SCLC are more or less likely to benefit from addition of atezolizumab or another immunotherapy.

quotes

Reply

Howard S. Hochster, MD (Posted: March 19, 2019)

quotes

This amazing article should be required reading for all physicians and healthcare administrators. The article explains why all the EHRs are essentially modified billing systems that do not serve the physicians or patients. Every physician spends many uncompensated hours doing notes at home in the evenings and weekends. This is an abuse and is a major factor in burnout. #takebackourtime

quotes

Reply

Howard Sandler, MD, MS, FASTRO (Posted: March 19, 2019)

quotes

Prophylactic cranial irradiation (PCI) is generally offered to patients with limited small cell lung cancer but hasn't been offered to non-small cell lung cancers. This prospective randomized study shows that PCI can alter the pattern of failure and has a large impact on the incidence of brain mets (HR = 0.43) but doesn't improve overall survival. Some toxicity has been reported as well. At this point, there would be little rationale for routine use of PCI in non-small cell lung cancer.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: March 18, 2019)

quotes

This is an interesting and complex finding. First it demonstrates that the relationship between testosterone and prostate cancer is complex - something that is not surprising. Second, it does not question the value of hormonal therapy as the article suggests. Hormonal therapy efficacy is well established - in the right setting. Hormonal therapy is not indicated in low risk localized prostate cancer. Finally, the finding has to be viewed as preliminary. This was not a randomized study. So it is not possible to say that testosterone replacement reduced the risk of relapse. There was not a proper comparison with a randomly selected identical control group. It is possible to say that the relapse rate was low and this is very encouraging. More work is needed in this area.

quotes

Reply

William McGivney, PhD (Posted: March 14, 2019)

quotes

Payer Prior Authorization: Intrusion, Disruption and Patient Harm
Is it any surprise that the frequency of payer prior authorizations continues to rise? The arrogance and greed of the payer/MCO industry dominates good sense and dismisses or, more to the point, disses patient well-being. Oftentimes, prior authorization programs are developed and marketed alone or in combination with other intrusive activities to the employer customers. The sale of such programs generates revenue that hits the bottom line of these payers/MCOs. Did you ever wonder why the Claims Cost totals are generally about 85-88% of the reported Medical Costs of a payer. As the oft-quoted Yogi Berra would say: “You could look it up”; although annual Claims costs are not always easily found.
A significant percentage of the Medical Costs minus Claims paid costs proceed to hit the revenue and profit bottom lines of payers/MCOs. In the drug/biologic world of Oncology, about 1% of prescriptions are ultimately denied. The disruption, delay and harm caused by intrusive prior authorization seems of little consequence to payors/MCOs as they forage and, more accurately, ravage the managed care landscape. I could go on and on but my soon-to-be-released book, On the Road to KICK-ASS HealthCare™ will tell the behind-the-scenes story.
One vignette sums up the absurdity of what we tolerate. An endowed professor at a prestigious Medical Center and longtime NCCN Panel Chair tells the story of what we will generously call a “Peer to Peer” discussion on a prior auth disagreement. The internationally respected medical oncologist found out that she/he was speaking with a cardiology nurse from the payer who proceeded to lecture her/him on what the relevant NCCN Guideline recommended. After exhibiting patience, reserve, and restraint, the good doctor informed the payer cardiology nurse that she/he, indeed, was the chairperson of the relevant panel and had been for many years. She/he then educated the cardiology nurse on what the particular NCCN Guideline really said.
This story might be amusing, if not for the fact that behind the enormous waste of time and money was a patient who thought that he/she had traveled the 300 miles to have this world’s leading oncologist determine what was best for her/him; not some script-bound cardiology nurse in some cubicle otherwise removed from the cancer care delivery system.

quotes

Reply

Debu Tripathy, MD (Posted: March 12, 2019)

quotes

We will be seeing many more biosimilars approved in the coming years. This term is applied to biological agents since they are not precise chemical structures and therefore cannot be called "identical". By the same token, they may not possess completely equivalent clinical activity and safety. Regulatory agencies do not require the same rigor of testing as a new indication for a biologic agent, but they do have to show "similar" composition, activity and safety. Typically, the clinical endpoint may not have to be as robust (for example statistically non-inferior response as opposed to progression-free survival in the advanced setting, and complete pathological response pre-operatively as opposed to disease-free survival in the early stage setting). Nevertheless, it is general accepted (by some but not all), that these are similar enough to be substituted for the brand name. It is estimated that in the US, this may result in 30-40% drops in prices - maybe not the dramatic effect we would like to see in cancer drug prices, but outside of the US, they might make the difference between large numbers of patients receiving biological drugs vs. not.

quotes

Reply

H. Jack West, MD (Posted: March 12, 2019)

quotes

This is an interesting and important finding, but the lack of an overall survival (OS) benefit will mean it should not have any significant clinical impact, since we already have data from Japan that have shown a reproducible improvement in progression-free survival (PFS) that has been quite profound but has thus far failed to translate into an improvement in overall survival. While a substantial improvement in PFS without an improvement in OS sometimes dictates a change in practice, the Japanese data have not led to any appreciable shift in practice since these data became available, generally due to the added cost, the introduction of an IV therapy that requires patients to come to clinic more than they would for oral therapy alone, and some toxicity risk. Because ramucirumab on the RELAY trial essentially just replicates the findings already seen with the erlotinib/bevacizumab combination, it's very difficult to imagine it leading to a different approach based on a very similar trial and agent. We would need to see a significant improvement in OS. Even then, osimertinib has become the first line standard of care, so the leading trial needs to be an anti-angiogenic agent with osimertinib in this setting. An alternative first line approach with considerable interest is that of chemo combined with osimertinib first line, based on the results of the NEJ-009 trial presented at ASCO 2018, which demonstrated not only a significant improvement in PFS and even OS with the combination of carbo/pemetrexed/gefitinib over gefitinib followed by chemo.

quotes

Reply

Debu Tripathy, MD (Posted: March 11, 2019)

quotes

This is a notable step forward in breast cancer therapeutics. Making advances, especially in survival, using immunotherapy has been a holy grail despite the long-held belief that the immune system is important in breast cancer when in fact, early immunotherapy trials using checkpoint inhibitors have been disappointing. However, the IMpassion130 trial is clearly positive - testing the addition of the anti PD-L1 antibody atezolizumab to nab-paclitaxel as first line therapy for PD-L1+ (in immune cells) triple negative breast cancer (TNBC). The indication does not specify line of therapy, but does specify the chemotherapy partner and need for PD-L1 testing. There will be a quick succession of results from additional trials - importantly, the KEYNOTE-355 trial testing the addition of pembrolizumab to one of three chemotherapy regimens also in the first line for TNBC is expected to report results later this year. Numerous randomized trials are ongoing (some preliminary already reported) in the neoadjuvant and adjuvant settings for all subsets of breast cancer. So expect an avalanche of data, but most importantly, more options for our patients that will hopefully make differences in survival and with some very long term responses.

quotes

Reply

Debu Tripathy, MD (Posted: March 09, 2019)

quotes

Criteria for clinical trials sometimes occupy several pages of a protocol, underscoring how selective they can be by excluding certain age groups, or those with decreased organ function. While some of these may be important for safety reasons, many times they are overly burdensome, especially for when they are intended for patients with refractory cancers who might be expected to have some limitations or physiologic abnormalities. When a new drug is approved, we are finding that the studies upon which the approval was based are so stringent in their eligibility, that "real-world" cohorts or registries must be studied, adding cost and delays in our understanding to true benefit and risk balance of a drug. Efforts to make trials more streamlined and reflective of the target population are welcome.

quotes

Reply

Howard Sandler, MD, MS, FASTRO (Posted: March 05, 2019)

quotes

This COG study (of about 350 pediatric ependymoma patients) identified a benefit to RT even in the very young, <3 year old, patients with ependymoma. While RT is clearly risky when given to the very young, tumor recurrence in the posterior fossa is also associated with adverse effects. One could probably argue that carefully delivered posterior fossa RT is less toxic approach if local control can be substantially improved as was apparent in this large COG study. Congratulations to the pediatric brain tumor community.

quotes

Reply

H. Jack West, MD (Posted: March 01, 2019)

quotes

We obviously need to see the actual data at the AACR presentation, but this is an important milestone, I expect. Blood-based testing had already gotten a big boost by the paper from Charu Aggarwal and colleagues in JAMA Oncology in ~Oct, 2018, and this presentation will likely bolster confidence among oncologists that blood-based NGS testing is now sufficiently sensitive and established to be used far more broadly.

Significantly, I think this will do a lot to lead to more patients getting NGS testing and greater detection of many targets. The oncologists committed to molecular testing were likely to get it even if it required an additional tissue biopsy -- it was those who were more skeptical or those who didn't want their patients or themselves to deal with the hassle of a tissue biopsy who will now take the path of far less resistance and order a blood-based test they can obtain right in the clinic lab and get their molecular testing that way. And the fact that it comes back a week or more before the tissue NGS test results is a further benefit that has been a significant barrier to broad adoption of NGS testing, at least tissue-based NGS testing, up to this point.

I eagerly await the data, but the abstract strongly suggests that this will be a big year for blood-based NGS testing.

quotes

Reply

Dean Gesme, MD (Posted: February 27, 2019)

quotes

BITE technology is extremely exciting! It will be important to see if the first product launches can avoid the extreme complexity and exorbitant total expense that has become a huge impediment to the implementation of CART therapies.

quotes

Reply

Howard Sandler, MD, MS, FASTRO (Posted: February 27, 2019)

quotes

Louis Potters and colleagues report out a phase I study of dose escalation for low/intermediate risk prostate cancer using 5 fraction SBRT of 40, 45, and 50 Gy. They didn't detect any increased toxicity with the higher doses although other centers have seen higher doses with 50 Gy in 5 treatments. So far so good, but a small study doesn't have the power to detect a small but meaningful risk of serious late toxicities. I don't expect to see a bunch of relatively rare events with 40 or even 45 Gy but before offering men a more convenient (but so far not more efficacious) treatment, one should be pretty confident about safety.

quotes

Reply

Howard S. Hochster, MD (Posted: February 27, 2019)

quotes

Great news for patients with BRCA mutation-related pancreatic cancer. Olaparib maintenance after induction with platinum-based chemotherapy extends time to disease progression (and hopefully, survival). This important study denostrates two key points:
1. Platinum based chemo sensitivity is a marker for PARP inhibitor activity and
2. Patients with BRCA mutation-related pancreatic cancer also can benefit from this class of drugs (previously shown active in breast and ovarian cancers). We now appreciate that BRCA biology is more similar across diseases than different.

quotes

Reply

Howard Sandler, MD, MS, FASTRO (Posted: February 22, 2019)

quotes

The PACE (Prostate Advances in Comparative Evidence) trial with two subcomponents: PACE-A and PACE-B is important in prostate cancer radiation and surgical oncology. PACE-B, recently reported some data comparing 'standard, 4-9 week' RT to 'SBRT, 5-fraction' RT, and is showing no difference in acute toxicity. If the tumor control is ultimately shown to be equivalent, then the shorter 5-fraction approach will be widely adopted (adoption is appropriately selective at this point). Results from the highly interesting PACE-A component, comparing surgery to SBRT, (not reported at ASCO GU Cancer Symposium) is eagerly awaited.

quotes

Reply

William McGivney, PhD (Posted: February 20, 2019)

quotes

CED for CAR-T: A Better Way to Assure Access to a Very Promising and Very Expensive Treatment
CMS has determined that Medicare will cover CAR-T therapy when such therapy is provided in the context of a clinical study or trial that CMS has approved. For CMS, this is a rare National Coverage Determination (NCD) in cancer care. The policy balances the opportunity and need to make available to patients a very promising new treatment and, at the same time, satisfy the need to collect, analyze and report out on data and evidence that relates to what surely will be an expanding list of tumor type indications and an expanding list of provider-setting types.
Many have likened the introduction of CAR-T therapy to the era of the introduction of high dose chemotherapy with bone marrow or stem cell transplantation. A difference in the CAR-T case is that the FDA has approved CAR-T products based upon some data submission. Further the price tags for CAR-T and HDCT-ABMT/SCT are both very expensive and the eventual total costs of CAR-T will only increase as such costs will include management of very serious side effects in some patients.
Years ago in the early 1990s, I faced the HDCT/ABMT/SCT issue at Aetna. In an invited editorial in the Journal of the National Cancer Institute (McGivney, May, 1992), I proposed the initial thinking around the importance and need for ongoing data collection (Coverage with Evidence Development) to define the therapeutic indices for the various tumor types that HDCT ABMT/SCT would be used for. In return at introduction of a treatment, coverage would be provided at 60-70 centers nationwide to assure widespread access. Without going into great detail, the application of CED to CAR-T will help us avoid the concerns, consternation and conflicts that enveloped the HDCT/ABMT/SCT technology. CED should be applied sparingly but every great once in a while, a very promising, very expensive technology or treatment becomes available that needs to be made available to patients in need but that also needs to have an evidence-based definition of its therapeutic index to evaluate the benefit to be derived by future patients, including those patients with expanded indications. As such, the present Medicare NCD provides access through Medicare coverage as financial support and supports use and access in a very judicious manner for this critically important therapeutic approach.

quotes

Reply

Howard S. Hochster, MD (Posted: February 20, 2019)

quotes

Another example of Immunotherapy in GI cancer not living up to the expectations (and hype). Despite some great results in prior single arm trials, the randomized 2nd line study of pembro vs BSC did not reach a HR of 0.78 for OS or PFS - though a positive effect was seen. Not unlike gastric cancer, these drugs have small effects in unselected GI patients and we need better markers for who will benefit (PD-1 expression, IFN signature etc) and better combinations of IO drugs. Sorry state of affairs but we must go back to the drawing board!

quotes

Reply

Howard Sandler, MD, MS, FASTRO (Posted: February 19, 2019)

quotes

New guidelines from ASTRO-ASCO recommend moderately hypofractionated radiotherapy for many men with prostate cancer based on multiple high quality randomized trials including an NRG trial: RTOG 0415. Patient reported outcomes from RTOG 0415 further support the safety of the shorter, hypofractionated regimen. The 3 largest, multicenter randomized trials (CHHiP, PROFIT, and 0415) have been practice changing and are providing men with a shorter, more convenient radiotherapy option.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: February 13, 2019)

quotes

As contemporary hormonal agents are increasingly used earlier in prostate cancer, the need for novel agents in castration resistant disease is increasingly acute. The promising results with LuPSMA could not come at a better time. We will eagerly await the results of the ongoing phase III trials

quotes

Reply

William McGivney, PhD (Posted: February 11, 2019)

quotes

Breast Implants; Déjà Vu All Over Again
Last week’s FDA warning regarding the association of breast implants with the occurrence (infrequent) of anaplastic large cell lymphoma (BIA-ALCL) focuses attention yet again on the implications of implanting a foreign object within the human body and the potential for immune system reaction to that object. This latest FDA warning reminds one of the issues raised during the early- to mid-1990s regarding an association of breast implants with the occurrence of autoimmune disease. The latest FDA warning raises a compelling issue for payers: “will payers cover the explanting of breast implants based upon a beneficiary’s concern about possible occurrence of ALCL?”.
For payers, the issue revolves around conservative coverage policy regarding preventative services. Generally, private payers reimburse only for preventative services (e.g., mammography, colonoscopy) that are recommended in recognized national guidelines. If a payer views the explantation of breast implants as a preventative service it will likely deny the surgical intervention to remove the breast implant. If there is an actual medical condition (e.g., inflammation due to saline or silicone leakage), a payer may then view the surgical intervention as treatment and provide coverage.
The other issue that arises above straight liability issues is: should manufacturers of breast implants be required to pay for the explantation of their breast implants. Twenty-five years ago, when the autoimmune issue arose, there were extensive business/financial conflicts within the major payers (e.g., Aetna, CIGNA) between the interests of the property casualty business within such companies and the health insurance side of the major insurance company. The property casualty components insured many of the breast implant manufacturers and thus were loath to the idea that their health insurer component might force manufacturers to pay. In essence, it would have been property and casualty side paying on behalf of the insured, the manufacturer.
It is likely that this FDA warning will not receive the prolonged, highly visible attention given the breast implant-autoimmune disease association but many of the same coverage issues will resurface within the health insurers.

quotes

Reply

H. Jack West, MD (Posted: February 08, 2019)

quotes

"Paleo pathology" is cool. Cancer goes back to the Triassic period.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: February 05, 2019)

quotes

Daralutamide would be the third agent with demonstrated efficacy in non-metastatic castration resistant prostate cancer if the ARAMIS trial yields positive results. Both efficacy and safety data will be of interest and clinicians evaluate a growing stable of options in this disease state where enzalutamide and apalutamide have been approved.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: January 31, 2019)

quotes

This study confirms one of the major trends in the field: that of intensifying upfront hormonal therapy in newly diagnosed metastatic prostate cancer. We have solid evidence that abiraterone or docetaxel improve outcomes when added to standard hormonal therapy early and now, apparently, similar results are being seen with apalutamide, an androgen receptor blocker. That is good news. We will eagerly await the full results as the magnitude of impact and the post-progression therapy experience of these patients will be an important determinant of how these results are interpreted in context.

quotes

Reply

Howard S. Hochster, MD (Posted: January 31, 2019)

quotes

Good argument for tort reform. No surgeon wants to be in court for doing the wrong surgical procedure if an incidental breast cancer is found. Juries and plaintiffs don’t tend to accept guidelines in the face of actual damages to a person.

quotes

Reply

H. Jack West, MD (Posted: January 24, 2019)

quotes

We are not privy to the data that the FDA have, but based on the TMB data that are publicly available, I think this is a very appropriate guidance by the FDA. We need more and stronger data to support TMB use for clinical decision-making. First, we need to see a survival benefit by using it; second, we need to see that the survival benefit is predicated on using the TMB test.

I think it is more likely than not that TMB will be a useful biomarker, but not the only one, in a few years. However, the data we've seen from CheckMate-227 are not sufficient to warrant using it.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: January 23, 2019)

quotes

This is an excellent reminder that genomic testing is fundamentally no different from any other diagnostic intervention. The context of use matters and the authors should be applauded for their work confirming that in low risk patients, this assays should not be used. The speed with which knowledge is growing in this area will challenge us to frequently reassess the value of emerging diagnostics. New development may alter the value balance. But along the way, clinicians should embrace novel diagnostics when they make a valuable contribution and avoid them when they don't.

quotes

Reply

Thomas Marsland, MD (Posted: January 22, 2019)

quotes

Financial incentives have and always will drive healthcare. There is no free lunch. This report focuses on treatment practices by physicians depending on the financial incentives. First I strongly believe doctors choose what treatments to recommend depending on what is best for our patients. When efficacy and toxicities are equal then the economics definitely come into play. There are systems where using more expensive therapies are chosen as well as systems where less expensive therapies maybe chosen if there is a financial incentive to do so. Many of the newer models are based on these concepts. Also I would like to point out that that comment about financial incentive clearly applies not just to physicians. Payers also have programs that alter treatment choices due to the economics (prior auths, step therapies, fail first, and more). Gee, bet the PBMs never look at the economics of the treatments they mandate. So let us all agree patients come first and that we need to continue to work to assure that financial incentives work to the benefit of all....

quotes

Reply

Howard S. Hochster, MD (Posted: January 22, 2019)

quotes

Another phase 3 trial of Gem-Abraxane with or without your favorite targeted agent. No particular rationale for using BTK inhibitor, ibrutinib, or patient selection for this pathway. And another negative trial without benefit. Let's get smarter.

quotes

Reply

H. Jack West, MD (Posted: January 17, 2019)

quotes

This application is based on the results of the IMpower130 trial of first line carbo/nab-paclitaxel with or without atezolizumab in patients with advanced non-squamous NSCLC (disclosure: I am an author on the abstract presented thus far and future publication). The trial is positive for not just an improvement in progression-free survival but also overall survival, which is an achievement. However, I see the limiting factor being that the true comparator in this setting today isn't chemotherapy alone, as was in the trial, but the KEYNOTE-189 combination of carbo/pemetrexed/pembrolizumab in the same setting. Though there can always be an occasion for which an alternative to the carbo/pemetrexed backbone is needed, this chemo regimen and the KEYNOTE-189 combination in general is one that the vast majority of lung cancer specialists and general oncologists alike are very happy to use as their preferred regimen. This will likely relegate the IMpower130 combination being considered here to very, very limited use. There is simply little to no incremental benefit it offers over KEYNOTE-189 in the same setting.

quotes

Reply

Howard S. Hochster, MD (Posted: January 15, 2019)

quotes

Another TKI for HCC! We now have 3 agents with variable tolerability profiles. Good news for patients as we have more choices. Now we need more studies on how to incorporate these agents with local therapies including resection, radiation, TACE, TARE and also in combination with immunotherapy. Exciting opportunities.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: January 14, 2019)

quotes

It is fascinating to see that greater complexity of cancer, typically associated with more aggressive behavior and greater resistance to conventional therapies, may be helpful in immunotherapy responsiveness.

quotes

Reply

(Posted: January 13, 2019)

quotes

Outrageous.... There is urgent an need to regulate the drug prices and reign in the greed of the big pharma

quotes

Reply

William McGivney, PhD (Posted: January 10, 2019)

quotes

ONLY Invested Over $100 Billion in R and D
A quote in the summary article provided belies the financial investments and contributions of the biopharma industry to the advancement of science and the resultant delivery of new drugs and biologics to the marketplace and, thus, to patients; (even some agents that are clearly game-changers like immuno-therapeutics). The quote is as follows:
“Research and Development is only about 17% of total spending in most large drug companies”.
Dare I say that the use of the adverb “ONLY” might evince a “bias” against the biopharma industry no matter how many billions of dollars that biopharma companies invest in biomedical research (basic and mainly clinical). Being generous let’s look at 2017 for the zenith of federal funding to all 27 of the Institutes, Centers, and Offices of the NIH. Budgeted funding was $33.1 billion. Trying to be scientific and methodologically sound, I looked for the spending by biopharma companies in the same year, 2017, on Research and Development. In an online article by John Carroll in Endpoints on April 24, 2017, the author delineates by company budgeted amounts for R and D in 2017. Being a fan of brevity and “get to the point”, I had to go down the list to ONLY company # 4 to best the NIH’s paltry (synonym for ONLY?) $33 billion by $8 billion with a sum for the 4 companies of $41 Billion invested. If one were to go through the list of the top 15, one would tally ONLY $90 billion invested in R and D. I do believe that there are many more biopharma companies out there to tally but I stopped at ONLY 15.
To what extent would a reduction in drug prices contribute to a proportional (e.g., percent of 17%) reduction in R and D dollar investments? One can ONLY guesstimate!

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: January 10, 2019)

quotes

We must take burnout seriously if we are to retain a robust physician work force. I would offer one observation. The discussion of physician burnout often occurs in a vacuum. We need to recognize that burnout is increasing in many segments of society. It is not a unique ailment limited to the medical profession. And we would be wise to consider the impact of technology, social media, and the resulting 24/7 work cycle on humanity. Many of the changes that we face have emerged rapidly and their full effect is just beginning to be recognized.

quotes

Reply

H. Jack West, MD (Posted: December 21, 2018)

quotes

This is an indication that, if approved, most lung cancer specialists won't be eager to support. Though patients with PD-L1 1-49% were included in the KEYNOTE-042 trial that came out positive, the subsets clearly illustrate that the study was positive DESPITE their inclusion, which just diluted the real benefit with pembro in the PD-L1>50% population already known to benefit from pembro over chemo based on the KEYNOTE-024 trial.

And while you could argue that pembro coming out with the same survival as first line chemo in the PD-L1 1-49% group represents a favorable option since patients can do just as well without the side effects of chemo, this isn't really true. The control arm getting first line chemo wasn't permitted to cross over, and only 20% of these patients ever got access to immunotherapy upon progression, which is a clear standard of care that has a consistently proven survival benefit. In other words, first line pembro merely looks comparable to first line chemo in survival for patients with PD-L1 1-49% who received substandard care on the control arm.

First line pembro is a poor option for patients with PD-L1 1-49% who are candidates for chemo/immunotherapy, or arguably even chemo followed by immunotherapy. KEYNOTE-042 should not be interpreted as making first line pembro a compelling option for these patients.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: December 20, 2018)

quotes

Intensification of therapy for newly diagnosed metastatic prostate cancer has become standard of care as a result of positive results with docetaxel and with abiraterone. It is not unexpected, therefore, that a similar approach with enzalutamide would yield favorable results. We will await eagerly the detailed results to better understand the effect of this combination.

quotes

Reply

Ted Okon (Posted: December 18, 2018)

quotes

As I informed Dr. Bach, at least one of his "fact check" statements are not factual. "...McKesson, which owns Texas Oncology (part of US Oncology)" is not correct because the physicians of Texas Oncology own Texas Oncology. It calls into question what other "fact checks" by Dr. Bach are incorrect.

quotes

Reply

sheila donnelly (Posted: December 18, 2018)

quotes

not good

quotes

Reply

H. Jack West, MD (Posted: December 14, 2018)

quotes

Though the authors and proponents from BMS highlight that the handful of patients who responded to nivo had a longer response rate than was seen with chemo, that's damning with faint praise for a therapy that will cost what nivo does. The vast majority of patients getting nivo for relapsed SCLC don't benefit.

quotes

Reply

H. Jack West, MD (Posted: December 14, 2018)

quotes

These data on MYSTIC stave off the executioner for durva or durva/treme in first line treatment of stage IV NSCLC, but I don't think they are favorable enough to call them highly encouraging. The reality today is that the true comparator is no longer doublet chemo alone but chemo with pembrolizumab, with decidedly better outcomes than chemo alone. In this setting, it's hard to conclude that durvalumab measures up even as a lateral move.

And while the TMB gambit provides a post-hoc escape hatch for a growing number of trials that fail on their original prospective design, these results for high TMB patients need not only to be replicated in a prospectively designed trial but need to prove superior to a general approach of chemo/pembro for the PD-L1 0-49% expression population, or pembro monotherapy perhaps for the high PD-L1 subgroup, to reach a tipping point of clear clinical relevance.

quotes

Reply

Thomas Marsland, MD (Posted: December 14, 2018)

quotes

Sorry to all my Pharma buddies but it is rare when I get excited when a detail rep come to visit. Today was the exception. The Bayer rep visited today (terrible lunch...) and presented the information on their (and Loxo) new NTRK inhibitor. I had seen the preliminary data at several of the national meetings and indeed they are impressive. It is exciting to see a new targeted drug approved on biology rather than tumor type. Hopefully this is something we will be seeing more of. The other exciting information was the drug support. As the article alludes to, it IS expensive but the program put together by Bayer and Loxo is very innovative and perhaps a model for others. They generously support programs but the best "value" proposition is the approach that the company will pay back if the patient doesn't respond. Wonder if DT is watching?

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: December 13, 2018)

quotes

This is a long term outcome report of an older study. It confirms the previous findings of a benefit of surgery for intermediate risk localized prostate cancer. it does not address the modern practice of active surveillance in low risk patients.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: December 12, 2018)

quotes

Performance equal to nomograms is certainly encouraging, but what is needed is performance that is better than nomograms. Nomograms are essentially a no cost tool that uses readily available information to calculate probabilities of cancer outcomes. To be successful, imaging needs to improve on the performance of nomograms.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: December 12, 2018)

quotes

MRI imaging prior to prostate biopsy is emerging as a strategy to reduce unproductive biopsies and increase the diagnosis of clinically significant cancers. NICE approval is an important acknowledgment of the value of this approach.

quotes

Reply

Howard S. Hochster, MD (Posted: December 08, 2018)

quotes

Once again, despite our hopes, and the imagination of the public, that a magic-bullet immunotherapy will work globally, we see the limitations of the IO approach. We justify possible activity on the basis of smoking-induced cancers or viral-induced, yet these cancers (like many solid tumors) are not melanoma. The era of continuing to throw anti-PD(L)1 and anti-CTLA4 agents against the wall and seeing what sticks needs to end. Let’s be smarter and try to select the appropriate patients using predictive markers!

quotes

Reply

H. Jack West, MD (Posted: December 07, 2018)

quotes

While it's nice to have a new approval, this is also a setting in which the IMpower150 regimen offers nothing beyond what we already have with the KEYNOTE-189 trial regimen of platinum/pemetrexed/pembrolizumab, except alopecia and neuropathy risk. The only real setting in which there is an unmet need now is for those patients with an EGFR mutation or ALK rearrangement who have received and progressed on a prior tyrosine kinase inhibitor -- these patients have been excluded from nearly all of the trials for chemotherapy +/- immunotherapy, but the carbo/paclitaxel/bev/atezo arm was associated with a PFS and OS benefit in EGFR mutation-positive patients at least as strong with addition of atezo to carbo/pac/bev as was seen in the broader population (not as clear that this can be said for ALK-positive patients). Unfortunately, the FDA approval specifically excludes patients with an EGFR mutation or ALK rearrangement, so I anticipate that this approval will (and should) have minimal impact on practice patterns, and we are left with no clear direction on how to approach patients with acquired resistance and EGFR mutation-positive NSCLC.

quotes

Reply

Debu Tripathy, MD (Posted: December 05, 2018)

quotes

Very interesting

quotes

Reply

H. Jack West, MD (Posted: December 05, 2018)

quotes

This will be an important development for thoracic oncology. The results of the IMpower133 trial, which demonstrated a significant survival benefit with the addition of atezolizumab to standard carbo/etoposide chemo as first line treatment for extensive stage small cell lung cancer (SCLC), were not astonishingly better than chemo, but they are enough that they should change the standard of care. Significant improvements in overall survival, even if not overwhelming, are infrequent enough in oncology in general and SCLC specifically, that we should be eager to adopt them when available. Having this regimen approved will make it far easier to pursue this combination broadly as a new standard of care.

quotes

Reply

H. Jack West, MD (Posted: November 27, 2018)

quotes

This is a big miss. Though even a positive result would need to be weighed for significance relative to the positive results for chemo/atezolizumab in the first line IMpower133 trial, the fact that this trial failed to improve survival compared to placebo in the maintenance setting is a great disappointment, especially on top of the recently reported (though only as a press release thus far) negative result on the CheckMate-331 trial of nivolumab alone vs. 2nd line chemo for relapsed SCLC. This result leads me to be far less inclined to consider either nivo or nivo/ipi as a very compelling option in relapsed SCLC, despite the FDA approval of nivo in this setting (actually 3rd line) earlier this year, or based on the Checkmate-032 phase II trial, which seems in retrospect to be yet another reminder of the power of selection bias. Should the emerging results also cloud our view on the utility of nivolumab +/- ipilimumab in NSCLC? Not enough to counter strong data, but we don't have particularly strong data in first line NSCLC at this time.

These negative results on CheckMate-451 also do not challenge the current concept of integrating immunotherapy into first line treatment for SCLC rather than deferring it as maintenance or 2nd line treatment. Though some are disappointed by the only relatively modestly positive results of IMpower133 with carbo/etoposide +/- atezolizumab, the significant improvement in OS should be sufficient to consider this approach the current standard of care for eligible patients. And the recent results with nivo +/- ipi in SCLC only underscore that significant gains in survival for patients with SCLC are quite hard to come by.

quotes

Reply

Howard Sandler, MD, MS, FASTRO (Posted: November 19, 2018)

quotes

It's very challenging to run clinical trials when patients are randomized to very different treatment, such as radiation vs. surgery. LDR brachytherapy has strong data supporting its use but there are limited randomized comparisons. It has been shown to be a relatively low cost monotherapy for prostate cancer but has limited use in the US due to a learning curve and limited practitioner base with expertise. The ASCENDE RT trial suggested a benefit to LDR brachytherapy as a boost when compared to EBRT alone but this finding is somewhat controversial since the study has so far only showed a PSA benefit but not a MFS or OS benefit.

quotes

Reply

T Cao (Posted: November 16, 2018)

quotes

It seems too early to approve this drug.

quotes

Reply

H. Jack West, MD (Posted: November 16, 2018)

quotes

I think there are a few key findings.

First, obviously nothing here changes our standard of care in advanced NSCLC.

Second, the durvalumab arm was statistically negative but had a hazard ratio for OS of 0.76, negative just due to prior alpha spending. These results don't supplant pembro in first line NSCLC, but don't represent a true failure of durvalumab that should lead us to question using it in a setting like stage III NSCLC, where consolidation durvalumab was highly positive for a PFS & OS benefit on the PACIFIC trial.

Third, the durva/treme arm looked worse. This may be due to toxicity limiting ability to treat. Regardless, I think we should have very little enthusiasm for this combination. We will need to see whether nivolumab/ipilimumab suffers the same date and whether selection by tumor mutational burden in IO combinations pans out.

quotes

Reply

H. Jack West, MD (Posted: November 16, 2018)

quotes

I think there are a few key findings.

First, obviously nothing here changes our standard of care in advanced NSCLC.

Second, the durvalumab arm was statistically negative but had a hazard ratio for OS of 0.76, negative just due to prior alpha spending. These results don't supplant pembro in first line NSCLC, but don't represent a true failure of durvalumab that should lead us to question using it in a setting like stage III NSCLC, where consolidation durvalumab was highly positive for a PFS & OS benefit on the PACIFIC trial.

Third, the durva/treme arm looked worse. This may be due to toxicity limiting ability to treat. Regardless, I think we should have very little enthusiasm for this combination. We will need to see whether nivolumab/ipilimumab suffers the same date and whether selection by tumor mutational burden in IO combinations pans out.

quotes

Reply

H. Jack West, MD (Posted: November 16, 2018)

quotes

I think there are a few key findings.

First, obviously nothing here changes our standard of care in advanced NSCLC.

Second, the durvalumab arm was statistically negative but had a hazard ratio for OS of 0.76, negative just due to prior alpha spending. These results don't supplant pembro in first line NSCLC, but don't represent a true failure of durvalumab that should lead us to question using it in a setting like stage III NSCLC, where consolidation durvalumab was highly positive for a PFS & OS benefit on the PACIFIC trial.

Third, the durva/treme arm looked worse. This may be due to toxicity limiting ability to treat. Regardless, I think we should have very little enthusiasm for this combination. We will need to see whether nivolumab/ipilimumab suffers the same date and whether selection by tumor mutational burden in IO combinations pans out.

quotes

Reply

Thomas Marsland, MD (Posted: November 13, 2018)

quotes

OK so I went into this with an negative attitude but actually to give the devil his due they actually did a good job with this report and program. (I might just point out that their CMO is Roy Beveridge a Med onc... and had I known that before I might have not been quite as much surprised Roy is one sharp fellow...) The program really emphasizes all the components we expect in a good medical home. There multiple studies that show that patient focus medical home programs (including in oncology) can produce savings and good care. Two comments: One of the individuals quoted in the Forbes article mentioned that it isn't about right place, right treatment, right time. But a lot of the saving resulted from reduced hospital admissions and ER visits so clearly place makes a difference. In oncology care clearly right drug and right time have to be a key component to any program. The other point I wanted to emphasize is that under the full value program the practice was responsible for 100% of part B services. Clearly again something like that would not work in the medical oncology setting. All in all though I was impressed with the organization and outcome from the Humana program

quotes

Reply

Ted Okon (Posted: November 08, 2018)

quotes

This is yet another mandatory experiment on cancer patient care that is terrible medicine and unconstitutional by using the Medicare Innovation Center to bypass the Congress and existing law. The regulators are now running medicine, and that is both scary and dangerous!

quotes

Reply

H. Jack West, MD (Posted: November 06, 2018)

quotes

Lorlatinib has significant activity for ALK+ and ROS+ patients who have even been treated with and progressed on prior TKIs. In fact, lorlatinib is uniquely effective for patients with more refractory ALK+ NSCLC, including good activity in the CNS. It has some toxicity issues ranging from elevated lipids to weight gain to confusion in some patients, but it is an agent we eagerly welcome for the patients who need it.

quotes

Reply

H. Jack West, MD (Posted: November 06, 2018)

quotes

Big loss for ACS. Dr. Brawley has been a very respected voice, and his discomfort with ACS decision on fund-raising partnerships will convey a strong message. The stature of the ACS drops with this development.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: November 05, 2018)

quotes

This study provides an important aggregate assessment of how men weigh survival and adverse effects when diagnosed with prostate cancer. But there is considerable variation between individuals in this regard. We must consider individual values and perspectives in weighing best treatment options.

quotes

Reply

H. Jack West, MD (Posted: October 31, 2018)

quotes

A very strong approval that was clearly needed. This regimen became the de facto standard of care after the presentation of the data at ASCO 2018 and represent a clinically as well as statistically significant benefit for patients with advanced squamous NSCLC regardless of tumor PD-L1 expression. This regimen is the consensus recommendation as the optimal regimen today for patients with advanced squamous NSCLC and negative or low PD-L1, and either this or pembrolizumab monotherapy are the strongest choices for the subgroup of patients with squamous NSCLC and high tumor PD-L1 expression.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: October 26, 2018)

quotes

Cancer hospital ads deserve at least the same scrutiny as other advertising, where deceptive marketing is not OK. Cancer patients are at vulnerable population and need accurate information that can serve as a basis for sound decision making. Anecdotes of exceptional outcomes - particularly when they are exceedingly rare - are not the way to inform patients about where they should get their care.

quotes

Reply

Stephen Lillard (Posted: October 25, 2018)

quotes

It’s becoming overwhelming the ad on with the immunotherapy is in biologicals. Need to go forward rapidly and reduced cost.

quotes

Reply

H. Jack West, MD (Posted: October 22, 2018)

quotes

Results of IMpower130 are certainly favorable and positive for the carbo/nab-paclitaxel/atezolizumab combination, but I think they are not going to displace carbo/pemetrexed/pembrolizumab as a regimen of choice in this setting based on the KEYNOTE-189 trial. Carbo/pemetrexed is a more commonly used and favored chemotherapy backbone for this population, and the results with IMpower130 cannot be considered superior to those of KEYNOTE-189.

It is notable that the patients with EGFR mutation or ALK+ NSCLC did not appear to benefit from the chemotherapy/immunotherapy combination, supporting the possibility that the benefit seen in this subset of patients in arm B of the IMpower150 trial (receiving carbo/paclitaxel/bevacizumab/atezolizumab) over the control arm of carbo/pac/bev alone may be a function of the inclusion of bevacizumab. We await further data to clarify this hypothesis.

NOTE: I am an author of the IMpower130 abstract/presentation.

quotes

Reply

Winston Wong, PharmD (Posted: October 15, 2018)

quotes

This piece is a great example of a pathway program in process. Clinical pathways are not meant to be static. Their goal is to decrease variability and improve quality, however through the learning process, must be updated based upon experience and new learning. Hence every good pathway program must be reviewed and update periodically.

quotes

Reply

Winston Wong, PharmD (Posted: October 15, 2018)

quotes

From a payer perspective, I do not think the clinical utility of the liquid biopsy has been show to warrant wide spread coverage. While I am a proponent of the liquid biopsy, I do not think it has gain "prime time" status. It has shown utility in only a few solid tumors, those of which are know to be active cell shedders. It will be interesting to see if payers will pick up coverage of the test.

quotes

Reply

Winston Wong, PharmD (Posted: October 15, 2018)

quotes

I have to wonder who the 2 negative votes are, and why did they oppose the bill. I also wonder how deep this regulation will go. If States have already passed similar bills, and the practice is still prevalent, there must be a loophole. Is that Loop hole in the contracting between the pharmacies and the network administrators, or by pharmacy corporate headquarters due to volume purchase agreements? I think there has to be more here than just passing a regulation to open up the lower price gates.

quotes

Reply

Winston Wong, PharmD (Posted: October 15, 2018)

quotes

I believe the difficulty here is not so much that a lower dose of drug when taken with a low-fat meal can produce a similar clinical effect, but rather, we are encouraging one to take their medications with food. The lower dose almost becomes a second issue. How many times are we telling patients to take their medication on an empty stomach e.g. antibiotics, biphosphonates? With that aside, in the patients who cannot afford their medication, this is an option. Education on a low-fat meal can serve 2 purposes: 1) offers an affordable option for abiraterone, and 2) promotes a more healthy diet.

quotes

Reply

H. Jack West, MD (Posted: October 12, 2018)

quotes

Disappointing result, especially since treatment with either topotecan or amrubicin in relapsed SCLC represents a very low bar for any competing idea. This represents an area where the standard of care is particularly unimpressive, so for nivolumab to have failed to beat chemotherapy here represents a major disappointment. With the positive OS data seen with IMpower133 that added atezolizumab to standard first line chemotherapy in NSCLC, we are likely to see immunotherapy move overwhelmingly into the first line setting, but here nivolumab suffers in comparison by failing to beat even a weak competitor.

quotes

Reply

H. Jack West, MD (Posted: October 11, 2018)

quotes

Notably, these results that are coming from academic centers may stem from them having more expertise, more access to newer agents and clinical trials, or some combination of these issues, but selection bias due to differences in the patient populations is always an issue with retrospective database analyses. The patients treated at academic centers have a better performance status and socioeconomic support, including people, funds, and other resources that also contribute to better outcomes. This isn't to say that selection bias explains the difference, but there are many contributing factors, and there is no question that the patients who receive care at academic centers are not the same population as those who don't, and these differences skew toward better results in these patients.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: October 08, 2018)

quotes

The results of OSPREY 2301 will need to be confirmed, but look quite promising and address one of the important needs in the field of prostate cancer. Improved imaging is essential to improve treatment decisions in early stage prostate cancer, and this approach may finally move us forward in this difficult area where little has changed in decades.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: September 28, 2018)

quotes

Optimal local therapy for high risk prostate cancer is not known. While this study suggest that surgery + radiation may yield improved outcomes over radiation (+hormonal therapy), population based analyses cannot provide high quality practice defining evidence. Treatment decisions were not made at random and likely incorporated a myriad of patient and tumor factors that patients and physicians consider when choosing therapy. The apparent difference is just as likely to reflect systematic patient selection bias as it is differences in the efficacy between two treatment approaches.

quotes

Reply

H. Jack West, MD (Posted: September 28, 2018)

quotes

Dacomitinib clearly has activity for EGFR mutation-positive NSCLC, but I suspect this approval will have very little impact in the already crowded first line landscape. Dacomitinib is clearly superior to gefitinib in both PFS and even OS based on the ARCHER-1050 trial. Osimertinib, however, is now the emerging first line standard of care and is likely to remain so for several reasons:
1) Dacomitinib toxicity is quite challenging, with 66.5% of patients assigned to daco on ARCHER-1050 requiring dose reduction and very high rates of misery-inducing side effects. Osimertinib is generally very well tolerated.
2) ARCHER-1050 excluded patients with known brain metastases, while osimertinib has consistently impressive CNS activity, with a CNS RR of 91% in the FLAURA trial among patients who started with baseline measurable brain mets. CNS control for existing or potential future brain mets is an increasingly significant factor when one option is clearly superior in this regard.
3) Though Pfizer may argue that starting with daco preserves the potential for osimertinib later, only a very small minority of the patients on ARCHER-1050 actually got osimertinib, so we should not presume this will be trivially easy to accomplish for the majority of patients. PFS for first line osi vs. daco is more than 3 months longer with osi.
4) At least among lung cancer experts, but I believe among oncologists in general, Pfizer has had very little presence, while AZ has been heavily marketing and running educational programs. This is a minor factor next to the data, but it is just one more obstacle for Pfizer to overcome. It has shown no interest in developing relationships with oncologists or in cultivating a sense of corporate citizenship by sponsoring educational activities or supporting other valuable programs in the oncology community over many years.

quotes

Reply

Thomas Marsland, MD (Posted: September 26, 2018)

quotes

Thanks Lucio - good job. It is hard to believe that there is not a concerted effort to destroy community practice. The sequester cuts represents just another nail in the coffin. If the new proposals in the PFS go forward as presented, community oncology will again face significant revenue reductions, forcing more closings and transitions to hospital based programs ( which is probably the intent). This will ultimately result in less access to care and a higher cost.

quotes

Reply

Thomas Marsland, MD (Posted: September 25, 2018)

quotes

How drugs are priced remains a huge black box. There is no question that costs are rising and making it more and more difficult for patients to obtain needed treatments. Although not a big fan of Dr E I do agree that "what the market will bear" plays a large part in that. Clearly research costs are a major component. It is unbelievable how expensive it is to bring a new drug to market. Certainly we need to develop less expensive research designs in the drug approval process. One point not made is the the US pricing is responsible for a large part of drug development costs, with pricing in other markets outside the US covering significantly less of those costs. How much of the cost of a drug comes from marketing is also a complete unknown? How much does direct to consumer marketing really cost and what does it really add for our patients? There are solutions out there. ASCO and others have developed position papers worth reading with some good suggestions on how to help control costs. Hopefully someone is listening.

quotes

Reply

Dean Gesme, MD (Posted: September 25, 2018)

quotes

In contrast, chemotherapy initiation in the outpatient setting is being continually delayed due to prior authorization of testing and treatment along with formulary restrictions and now step therapy requirements.

quotes

Reply

William McGivney, PhD (Posted: September 25, 2018)

quotes

C-VICER: CVS Embraces ICER
We have reached a very sad time when a major corporation (CVS Health) embraces and is willing to integrate the skewed and obtuse work products of the pedantic ICER into treatment coverage decisions about patients diagnosed with cancer. It is always interesting to see companies willing to limit access while wanting at the same time to have a third party to point the finger at.
Instead of proceeding, I will quote an important article from OBR Green published on October 19, 2016. After reviewing the ICER analysis on Non-Small Cell Lung Cancer, five eminent lung cancer docs stated:
“ICER appears to represent a perspective that is less oriented towards patient benefit than towards motivations that would limit patient access to therapeutic options. ICER’s clinico-economic methods include approaches and metrics that, due to their singular focus on population health, would likely fail patients on an individual clinical needs basis. ICER’s philosophy appears to be similar to that of NICE in the UK, whose limitations placed on drug access have been correlated with lower cancer survival rates in the UK compared to the rest of Western Europe.”
“For us as practicing oncologists and lung cancer researchers, this report has raised serious concerns regarding ICER’s ability to interpret clinical evidence and reach conclusions on drug value that are scientific, comprehensive and unbiased.”
Enough said!

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: September 18, 2018)

quotes

While there is room for a range of views, this is a situation where there must be room for clinical skill and judgment. Skilled clinical assessment and monitoring of cancer status, carried out by an expert oncologist would very likely capture the benefits of abiraterone even if dosed in an alternative fashion. Oncologists do not practice strictly "on label" in any disease. They integrate best available evidence and apply it to each individual patient's unique circumstance. There is no question that the evidence is strongest for conventional food-free dosing, but there is now sufficient evidence to have a through discussion with individual patients about the option of alternative dosing when the economic consequences of not doing so may deny the patient access to the drug altogether.

quotes

Reply

Thomas Marsland, MD (Posted: September 18, 2018)

quotes

Delays in accessing the appropriate therapy for patients is a growing problem. Step therapy is just one of another barrier that the payer community is implementing to reduce access to needed drugs. This is especially true when one looks at the entire PBM companies that are rapidly expanding. These programs limit access and delay care. PBMs are a huge black box where transparency is nowhere to be found. Payers use these companies which more and more are part of the payer community itself. How these entities determine which drugs are preferred as part of fail first and step therapies is completely unclear. These organizations are compensated by payers and negotiate discounts and rebates with industry reaping large profits that can drive drug preferences and determine how step therapies are determined. There often is no savings for patients and care is delayed. Adding Part B drugs to this failed system will lead to further care access problems for patients.

quotes

Reply

Winston Wong, PharmD (Posted: September 18, 2018)

quotes

Spread pricing has been a revenue generating tool for many years. Even I am surprised by the extent of the spread noted in the piece. I am not sure how spread pricing adds to the pricing stability for a payer, but it definitely contributed to the higher costs.

quotes

Reply

William McGivney, PhD (Posted: September 17, 2018)

quotes

“Your First Chance is Your Best Chance”
The title used to be the tagline for some of the advertisements of Memorial Sloan Kettering. CMS has either not heard or dismisses such considerations given the recent announcement to allow Medicare Advantage Plans to enact Step Therapy programs for Part B agents. As quoted in the Forbes article, “Step therapy is controversial. It is the most onerous condition of reimbursement in that it defers certain treatments until a later point in time”. It all just seems to get worse and worse for physician autonomy and patient well-being.
Does CMS not see the distinct possibility in this program of actually increasing the variability of Medicare beneficiaries’ access to therapies given that it is quite likely that MA Plans will have Step Therapy Programs that will differ, one from the other? Will MA Plans deftly handle Part B to Part D stepping processes with a lack of understanding of patient likelihood of non-adherence under Part D. What will implementation of such a Program do to personalized medicine with biomarker-directed care? How long will such step therapy policies delay drugs/biologics for patients in need?
The list of concerns goes on and on!
An NCCN Panel Chair recently told me the story of that person’s latest “peer to peer” discussion with a payer. When the Payer’s cardiology nurse finished misquoting the relevant NCCN Guideline, the Panel Chair told her that she/he was actually the Chair for that Panel and cited the page and line that justified the use of the drug in question.
How will a patient’s first chance be guided with this “most onerous condition of reimbursement” being applied by well-meaning cardiology nurses?

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: September 13, 2018)

quotes

Low sensitivity seen in this trial is a bit of a disappointment. We will need to learn more about this result as the data are fully analyzed, presented, and published. Low sensitivity means that a negative result is not as reassuring for patients as one would have hoped.

quotes

Reply

H. Jack West, MD (Posted: September 12, 2018)

quotes

The results of KEYNOTE-042 were positive for an OS benefit of pembro over platinum doublet chemo as first line treatment for patients with tumor PD-L1 expression 1% or higher (about 2/3 of patients), a broadening compared to the established place for pembro as first line treatment for patients with tumor PD-L1 expression 50% or higher (about 30% of patients). However, reviewing how different subgroups did actually demonstrates that the patients in whom pembro was superior was limited to the 50% and higher group that we already treat with first line pembro. The entire trial, including patients with a lower PD-L1 threshold of 20% or 1%, was positive only because the good results were driven by the high PD-L1 group and were favorable enough to still be positive for the trial even after being DILUTED by the lack of benefit for pembro in the lower PD-L1 patient subgroup.

One could argue that the results with pembro in the 1-49% group are comparable for OS as that seen for patients who started with chemo, and pembro is better tolerated, so why not favor it? The answer is because the trial prohibited crossover to pembro upon progression, and only 20% of the patients assigned to first line chemo ever got an immune checkpoint inhibitor off protocol subsequently. This represents an unfair comparison in which pembro only looks comparable to a chemo arm that was severely handicapped by being denied a treatment that is extremely well established as a standard of care as second line treatment with a consistently proven strong survival benefit. In the US, three checkpoint inhibitors are approved and widely used as second line treatment after initial chemotherapy, so the first line pembro arm only comes out looking as good as a first line chemo arm that received what we can only consider overall sub-standard care on the control arm. This isn't just a revisionist view based on current standards, but represents what was a standard of care in the US while this trial was being conducted.

I review the trial results and discuss these issues further in my video here:
http://bit.ly/BMIC38

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: September 10, 2018)

quotes

Intermediate endpoints can speed the delivery of impactful drugs to patients and in prostate cancer, where we now have multiple lines of therapy, it is important that we consider intermediate endpoints because overall survival can be impacted by subsequent therapies and take a long time to measure. But the progression-free survival advantage has to be clear and compelling in quality and magnitude to serve as a robust measure of patient benefit.

quotes

Reply

Winston Wong, PharmD (Posted: September 08, 2018)

quotes

While reality demonstrates that these practices do create issues with regards to access and financial toxicity, it is a bit one-sided in that if the PBM is doing their job, there are patient support benefits. The key issue here is that some pharmacies are more efficient and better at providing these services than others. Patient follow-up, compliance and adherence monitoring are among the benefits. No question that there are major disconnects, and fixes are needed. Unfortunately, they are a result of our disjointed health care system.

quotes

Reply

Winston Wong, PharmD (Posted: September 08, 2018)

quotes

While there may be some truth that there is a lack of confidence with biosimilar products, I believe that the confidence level is increasing, thus not the reason for the slow uptake in utilization. I believe that the true reason for the slow uptake is due to contracting and rebate levels increasing with the reference product so that there is little motivation for any stakeholder to switch to the biosimilar product. The power of the rebate is so woven into the selection process that unless the biosimilars start to represent more significant deeper discounts than they do today, uptake will continue to be slow.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: September 07, 2018)

quotes

A thoughtful and careful approach to interpreting results of novel imaging scans is essential. But beyond that, how physicians use the new information also merits careful considerations. Metastases that are only detectable via a high sensitivity scan may not have the same prognostic implications as the presumably higher volume metastases that are detected with conventional imaging. Novel imaging strategies offer opportunity to improve care, but only if deployed with care, thought, and a fair amount of humility.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: September 06, 2018)

quotes

The most prominent guidelines recommend shared decision making after a thorough discussion about the potential benefits and risks of PSA screening. These recommendations reaffirm this position. Routine screening would imply no particular dialogue and use of screening in all healthy adults, and there is near universal agreement that the available data do not support this. However, the available studies have significant limitations, among the control arms including some screening and importantly the absence of more modern approaches to management of prostate cancer which decouple diagnosis from treatment and include observation. Prostate cancer screening remains a vexing challenge and better tests are needed. For men who chose to be screened, thoughtful and careful consideration of what to do if a cancer is diagnosed is essential.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: September 05, 2018)

quotes

"Hormone Therapy Can Make Prostate Cancer Worse" is a scary and attention grabbing title. Too bad. The research reported is yielding important understanding about mechanisms of resistance to hormonal therapy. But there is no need to scare people about hormonal therapy. This type of treatment remains the mainstay of managing prostate cancer and the treatment improves survival and outcomes even if ultimately resistance develops. Patients should not be scared away from treatment by this misleading headline.

quotes

Reply

Ted Okon (Posted: August 29, 2018)

quotes

Very important analysis conducted by Dr. Lucio Gordan and fellow researchers. Shows the adverse impact that the sequester cut has had on community oncology practices. It's staggering to realize how much these practices have lost. The sequester cut applied to Medicare Part B drugs is illegal, which is why COA is suing the federal government.

quotes

Reply

Ted Okon (Posted: August 29, 2018)

quotes

Very good article in the New York Times that explains how the 340B drug discount program has mutated from its intended purpose. The program has become a financial windfall for many hospitals. I simply can't understand why hospitals using the program correctly to help those in need let other hospitals drag down this critical safety net program.

quotes

Reply

Dean Gesme, MD (Posted: August 27, 2018)

quotes

We always hear about outrageous costs of health care. Why are we not also outraged at our legal system's outrageous excesses?

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: August 23, 2018)

quotes

Presumably, the amendments to these trials reflect the sponsors's expectation of a larger effect size than originally planned enabling an earlier analysis. One would also note that the landscape for androgen receptor targeting in prostate cancer is increasingly competitive with multiple products on the market and in clinical trials.

quotes

Reply

H. Jack West, MD (Posted: August 21, 2018)

quotes

This was an appropriate and not surprising full approval in the wake of the highly positive KEYNOTE-189 trial. Doesn't change much, as we've already had carbo/pem/pembro approved since May, 2017 based on the much smaller & less conclusive KEYNOTE-021g trial, and we've known impressive results of KEYNOTE-189 since mid-April's presentation of the data at AACR and simultaneous publication in NEJM. This has led to broad adoption of this regimen as a clear standard for non-squamous NSCLC.

The inclusion of any platinum, opening up cisplatin as well as the previously specified carboplatin, with pemetrexed and pembrolizumab isn't a major added feature, since the vast majority of US oncologists favor carboplatin in this setting, particularly with KEYNOTE-189 showing a higher incidence of renal toxicity with the chemo/pembro combination than we'd expected.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: August 16, 2018)

quotes

These Challenge awards are an exceptional selection of projects in prostate cancer research. They share two key attributes: they tackle really important problems in prostate cancer, and they do so with a high degree of innovation.

quotes

Reply

Winston Wong, PharmD (Posted: August 13, 2018)

quotes

Specific to cancer care, it will be interesting to see how the discussion plays out with the allowance of so-called "Step-Therapy" and the requirement to cover anything listed in the NCCN guidelines. Will the two be allowed together?

quotes

Reply

Winston Wong, PharmD (Posted: August 13, 2018)

quotes

Unfortunately, stories and reports like these are all too common. I have to wonder as I read this. Was the misfortune due to the mis-interpretation of Neulasta Onpro vs. Neupogen? The majority of Neulata is under the medical benefit. I can see the Neupogen being forced through specialty and self-administered. Nevertheless, the timing for responses was poor.

quotes

Reply

Winston Wong, PharmD (Posted: August 13, 2018)

quotes

Interesting article. Cites insurers and employers as the revenue hounds. Not entirely true. Yes, these are the true payers, but I would contend that employers don't see a large portion of the rebates. The article states PBM's and Insurers are largely opposed to the elimination of rebate. Why would you be opposed if it did not matter to you. The article implies the PBM's only keep a small percentage and pass on the rest. HUH? This is why we need a more transparent system in place. We can still have the rebates to promote competition, but we also need clear and clean tracking of the dollar flow.

quotes

Reply

H. Jack West, MD (Posted: August 08, 2018)

quotes

This doesn't mean that NGS testing is useless, but we must be careful not to oversell it as a miracle. It actually helps relatively few patients beyond standard, limited testing right now, with no improvement in survival in population-based evaluation, at least corrected for other variables.

However, it is a more tissue-efficient way to test for 4-5 or more markers, as we should now be doing for non-squamous NSCLC, and the value of NGS is likely to be a moving target only rising over time. My conclusion is that we should stop over-promising what precision oncology will deliver, but we also shouldn't throw out the baby with the bathwater.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: August 06, 2018)

quotes

This important discovery is beginning to uncover the mystery of one of the most common translocations in human cancer. The TMPRSS-ERG translocation and related similar translocations are found in about half of all prostate cancer, strongly suggesting that they are important to prostate cancer. But what they do and how to target them has been elusive. The observation that this translocation activates a set of other genes that in turn likely drive prostate cancer may explain not only what it does but suggests that once these carcinogenic effects are established, targeting TMPRSS-ERG itself may not be effective. The downstream effects of the gene are where the action is likely to be in cancer treatment. At the same time, perhaps TMPRSS-ERG itself can be targeted for prevention.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: July 31, 2018)

quotes

MAO-A was previously shown to be elevated in higher grade prostate cancer and our group previously reported that chemotherapy treatment resulted in elevated MAO-A levels and that MAO-A in turn modulated chemotherapy resistance (PLoS One 2014). The exciting feature is that there are drugs that are available off the shelf that can inhibit MAO-A. The concept needs to be tested.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: July 27, 2018)

quotes

While this restriction is a result of an unexpected deleterious outcome of a clinical trial of Xofigo in combination with abiraterone, it is worth considering the broader context. In the ALSYMPCA trial, which established Xofigo's role in prostate cancer care, Xofigo was studied in patients with heavily pre-treated, poor prognosis disease. The median survival in the control group was less than 12 months. Since approval, some have advocated for earlier use of the agent, but to date, no level I evidence in support of that has emerged. The EMA action has the effect of focusing European prescribers on patients that more closely resemble those who participated in the registration trial.

quotes

Reply

Jeff Patton, M.D. (Posted: July 27, 2018)

quotes

I found this article both fascinating and enlightening. I had not thought of "burnout" in terms of moral injury but it makes total sense. Regulators, bureaucracy and technology have gotten between patients and providers and it is literally sucking the life out of providers. We have to address these issues and a grand scale. Having practiced for 25 years I can say with confidence the experience of providers has deteriorated significantly.

quotes

Reply

H. Jack West, MD (Posted: July 25, 2018)

quotes

Nice to see, though not surprising. Brigatinib is a very good second generation ALK inhibitor, at least comparable to if not more efficacious than alectinib, which crushed crizotinib in the ALEX trial that was a head to head comparison of the two. The real question is whether brigatinib will look like a lateral move or possibly meaningfully better than alectinib when we're left to do our cross-trial comparison of ALTA-1 results to those from ALEX.

We'll look forward to seeing the actual results in one of the fall meetings -- not sure if that will be WCLC in Toronto or at ESMO in Munich.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: July 24, 2018)

quotes

Decoupling treatment from diagnosis is a critical priority in prostate cancer. Low and very low risk patients are appropriate candidates for active surveillance. It is encouraging to see molecular tests emerge that may help identify patients who are at low risk from their disease.

quotes

Reply

H. Jack West, MD (Posted: July 20, 2018)

quotes

Very unfortunate and very believable. Some proponents of complementary medicine note that "complementary" is intended to mean that these treatments are given alongside conventional therapies, rather than instead of them, as "alternative" medicines will be. Nevertheless, this work strongly indicts treatment philosophies that are not grounded in clinical evidence and shows that they clearly subtract more than they add for patients with treatable cancers, who are all too often presume that the "medicine" in complementary medicine is actually effective. That is the greater misnomer here, and it leads to net harm to the people gullible enough to pursue it.

quotes

Reply

H. Jack West, MD (Posted: July 19, 2018)

quotes

On balance, these data for advanced non-squamous NSCLC compare unfavorably to those of the very similarly designed KEYNOTE-189, another platinum/pemetrexed +/- immunotherapy trial (with placebo on control arm), with IMpower132 showing a significant PFS benefit but failing to demonstrate an OS benefit. This pattern strongly echoes what we saw with IMpower131 vs. KEYNOTE-407 in the setting of advanced squamous NSCLC.

Taken together, pembrolizumab and Merck clearly have the upper hand here, and we would interpret that pembrolizumab is a more efficacious agent. However, I hope to delve more into the practical issue of the actual crossover rates of these two trials to clarify whether a higher crossover on the IMpower trials may contribute to the absence of a significant OS difference. In KEYNOTE-407 and KEYNOTE-189, for instance, crossover was permitted but was still only in the range of 43-50% of eligible patients. If only half of the patients on the chemo only arms of these KEYNOTE trials ever received effective immunotherapy at any point, but a clear majority of the patients on the chemo arms of the IMpower trials received immunotherapy on crossover, it could explain how pembro appears to be conferring a survival benefit not seen with atezolizumab. If no real difference in the crossover rates, then the nod simply needs to go to pembrolizumab for greater efficacy. Regardless, I fear that even if it turns out that crossover rates explain the OS difference more than true drug efficacy, the world may end up failing to care about such details, and rather just punishing Roche for running trials in a way that is better for the participating patients but that undermines their ability to report an OS benefit.

quotes

Reply

Winston Wong, PharmD (Posted: July 17, 2018)

quotes

One has to wonder if the move to reimburse new drugs at WAC+3% will be an indicator of the all drugs being reimbursed at ASP +3%. What is unclear is what then is the resultant reimbursement, if there is a change, due to the sequestration removal?

quotes

Reply

Winston Wong, PharmD (Posted: July 17, 2018)

quotes

I really have to wonder just how effective transparency laws are, given that there have been transparency laws pass years ago governing the PBM industry, and nothing seemed to change. The easy example is the Pharmacy GAG requirements.

quotes

Reply

Dean Gesme, MD (Posted: July 13, 2018)

quotes

CMS action on clinical documentation requirements to reduce redundant and superfluous charting is greatly welcomed by those of us who may now have more time to care for patients as opposed to “buffing the chart” to meet coding requirements.

quotes

Reply

Thomas Marsland, MD (Posted: July 11, 2018)

quotes

I absolutely agree with the COA comments. The intent of the 340B program is laudable. We clearly need to make every attempt to improve access to high quality care for those who need economic assistance. Unfortunately there have been multiple abuses of the system that have effected those goals. These abuses have resulted in many providers enriching themselves but using the program to provide drugs for patients with adequate resources. These activities have resulted in the migration of physicians out of private practices to hospital centered programs. This migrations has definitely altered patterns of care which clearly needs to be studied. As you know your ASCO delegation recently was successful in getting a resolution passed at the annual AMA meeting getting AMA support for greater oversight of the 340B program.

quotes

Reply

Winston Wong, PharmD (Posted: July 11, 2018)

quotes

The disagreement on how to define "value" goes far beyond that of the Oncologist. I think the most significant statement made was at the very end where the author stated that no one can agreement on what the definition of value is. hence we are all just chasing a concept that is yet to be defined.

quotes

Reply

Winston Wong, PharmD (Posted: July 09, 2018)

quotes

The math is simple. Under the proposed agreement, we pay for all doses of the CAR-T, and get refunded the cost when the patient does not fully respond. At worse case, you pay for everyone's dose. On the other side, we pay for everyone's dose. If it does not work, no refund, and we continue treatment with another agent. Who's the winner here? I'm not even sure.

quotes

Reply

Winston Wong, PharmD (Posted: July 09, 2018)

quotes

I would challenge anyone to attempt to tell me at the end of the day just what the exact cost of the medication is. Its really becoming a racket with rising prices, only to be countered by rebates and copay cards, and bumped back up by accumulator programs. At the end, the patient gets stuck. Why not just try the more effective drug first?

quotes

Reply

Richard Reililng (Posted: July 07, 2018)

quotes

Can't imagine that anyone would find this a surprise. Patients needing pain relief will suffer because of the weak personalities that take narcotics unnecessarily and for less than appropriate reasons. We have tried to fight this in many arenas including the AMA, but the 'bleeding hearts' win the field all the time. Let's hope that our cancer patients get what they need, when they need it, and in the quantity that makes their lives more tolerable in view of their disease processes.

quotes

Reply

Tomasz M. Beer, MD (Posted: June 25, 2018)

quotes

Several interesting things about this study. Combination checkpoint inhibition has proven useful in other cancers, but is new to prostate cancer. Patient enrollment using the AR-V7 assays to select highest risk patients is novel and represents the first such study. Finally, the links between DNA repair defects and response extends prior findings and provides new evidence that this relationship may extend beyond microsatellite instability. This regimen is not ready for clinical use, but is of interest for further study.

quotes

Reply

Thomas Marsland, MD (Posted: June 22, 2018)

quotes

Gee, I recognize a few of those names.....As you probably can guess from my responses, I tend to binge read my OBR reports....(binge my House of Card series too....). Anyway, some comments on the AMA meeting. AMA as always is a lot of fun. The house of delegates is so diverse with old white dudes like myself mixed with energetic ladies (go Barb...rock star), individuals of all political sides, young docs starting their journey, folks of all racial backgrounds, and people of all sexual identities. We get together and argue the profound and esoteric. The debates are always respectful and we all leave as friends. This year, gun control, opioid issues, physician assistance in dying were hotly debated on the floor. In addition there was the usual alphabet soup of resolutions on MOC, MACRA, and payment resolutions. Our ASCO delegation (EB, RP, SL, KN, MF, ES and yours truly) proposed 5 resolutions. Two were reaffirmed (cancer survivorship care plan, alcohol and cancer). The three in the article were accepted with some amendments. All in all, we were happy with the results. As you know 340B needs a lot of work, and PBMs need some over site too. The electronic transfer of prescribed opioids will make life better for patients and docs. With all this busy agenda we even had time to hit Buddy Guy's House of Blues....(thanks Ray...). So if anyone ever asks what AMA does, the answer is everything. They are a strong voice advocating for our patients and us.....

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: June 21, 2018)

quotes

Increasing availability of molecular tests to risk stratify patients is encouraging. With over-treatment of low risk disease a core challenge in prostate cancer, the use of such tests to increase the proportion of men opting for observation would mean progress. For this to happen, urologists, oncologists, and patients will need to be comfortable trusting the results and acting on them. The tests should only be used when the clinician is willing to act on the result.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: June 20, 2018)

quotes

With about half of the patients who initially choose active surveillance progressing to definitive therapy, there is an opportunity for low toxicity interventions to reduce the need for more aggressive therapies. While sipuleucel-T was successfully developed for prostate cancer, a number of other vaccine based immunotherapy strategies have not succeeded. This is the first one being deployed in the active surveillance setting.

quotes

Reply

Tomasz M. Beer, MD, FACP (Posted: June 20, 2018)

quotes

The choice of Gawande suggest that this venture will set ambitious goals and evaluate health care holistically. Gawande will not be afraid to challenge the status quo and will bring creative and constructive approaches to the challenge of health care cost and quality.

quotes

Reply

H. Jack West, MD (Posted: June 07, 2018)

quotes

This work is certainly provocative, but there are several issues that should lead us to be cautious about concluding that this should change practice. Not only was this not a large trial, but the patients in the control arm who received erlotinib alone demonstrated a response rate that was remarkably low for EGFR mutation-positive cancer, about half of what is more commonly seen. There have also been other trials that have been far less impressive but not publicized. Overall, it merits further study but needs validation before being considered a combination approach to pursue outside of an investigational strategy.

quotes

Reply

Thomas Marsland, MD (Posted: June 06, 2018)

quotes

So back to the grind stone... in clinic today after and exciting ASCO AM. But as this article suggest there is no free lunch. All of these great exciting life prolonging therapies come at a great cost. The theme of the meeting was personalized care and certainly this offers opportunities to help control the costs but even there with the new (FDA approved) next generation testing we still are often left with many expensive choices for a given patient with really no knowledge of success rates. But there is I think hope on the horizon. I had the chance to meet with a group that is developing highly sophisticated computer programs that can actually predict which of the many mutations noted by the ngs testing will really result in a therapy with a high success rate. (and the flip side avoid those that don't.) The data bases are quite sophisticated and developed from true clinical trial materials. When these types of programs become universally available we really will have the idea of "personalized" therapy come to fruition. Then hopefully these costly treatments will be given to those who truly will benefit.

quotes

Reply

Ted Okon (Posted: May 31, 2018)

quotes

It is very disappointing that this Administration would not undo the unconstitutional mistake of the previous Administration applying the sequester cut to Medicare Part B drug reimbursement. This legal action was the last resort of the COA Board.

quotes

Reply

H. Jack West, MD (Posted: May 29, 2018)

quotes

Important trial result, positive for both PFS & OS benefit, that confirms benefit of first line chemo-immunotherapy, here with atezolizumab added to carbo/nab-paclitaxel in patients with advanced non-squamous NSCLC, is not specific to a particular chemo backbone or immune checkpoint inhibitor. Instead, it's looking more and more like relatively comparable results will be seen in multiple trials, and we'll have a choice of chemo doublets paired with checkpoint inhibitors.

In that setting, people will gravitate to the chemo regimens they prefer in this setting, and in the US, I think carbo/pemetrexed will be favored for most patients with advanced non-squamous NSCLC. I think with KEYNOTE-021g regimen of carbo/pemetrexed/pembro already FDA approved and KEYNOTE-189 looking so impressive, this will be the default regimen. This means that any new chemo/immunotherapy combination will be reviewed in the context of whether it provides a meaningful incremental benefit over carbo/pem/pembro. I don't think carbo/nab-paclitaxel/atezolizumab can be said to be anything more than a lateral move at best.

The only real caveat I'd offer is the possibility that the story of steroid treatment with chemo/immunotherapy or immunotherapy alone may detract from the benefit of immunotherapy, which some retrospective work has indicated, though the 3 days of premedication with pemetrexed likely wouldn't register as enough to undermine the benefit of immunotherapy, and certainly the highly positive results of the KEYNOTE-189 trial argue against that.

quotes

Reply

H. Jack West, MD (Posted: May 25, 2018)

quotes

This finding of a significant OS result was as I would have expected -- with the profound and sustained PFS benefit going out to at least 18 months, as well as a significant benefit with consolidation durvalumab in time to new metastatic disease or death, it was nearly inconceivable that there wouldn't be a significant improvement in OS. What remains to be seen, however, is whether this will be a sustained OS benefit that actually raises the tail of the curve and leads to more patients alive and without disease at 3 and 4 and more years, or whether the year of durvalumab is just delaying the relapse that would otherwise occur in the same proportion of people. In other words, can immunotherapy eradicate the residual disease in people who would otherwise be destined to relapse and die of their cancer, leading to more cures, or is it merely suppressing the disease that will still lead to relapse, just now with enough of a time delay to lead to a transient improvement in survival.

We await not only the data leading to this press release, but also the more longitudinal results of this important trial.

quotes

Reply

H. Jack West, MD (Posted: May 24, 2018)

quotes

KEYNOTE-407 was already #2 on my top 5 abstracts in lung cancer for ASCO 2018, behind only the KEYNOTE-042 Plenary Session presentation, but this latest press release now makes it rival KN-042 in significance.

With the new results of a significant PFS and OS benefit on top of the already reported 23% higher objective response rate noted in the abstract, we should expect that this will lead to a timely approval of this combination of carbo/nab-paclitaxel/pembrolizumab for first line treatment of advanced squamous NSCLC, regardless of tumor PD-L1 expression level. The landscape is likely to mirror that for non-squamous NSCLC, where a chemo/immunotherapy combination (carbo/pemetrexed/pembro) is approved regardless of PD-L1 expression, while the leading alternative is pembro monotherapy for patients with high PD-L1 based on KEYNOTE-024, or soon even for those with PD-L1 1% or higher, based on KEYNOTE-042.

So in both squamous and non-squamous NSCLC, it's very likely the leading alternatives will be pembro monotherapy vs. chemo/pembro for those with tumors positive for PD-L1, and chemo/pembro for those whose tumors are PD-L1 negative. IMpower131 will also feature some positive results with carbo/nab-paclitaxel/ataezolizumab, but thus far we know only about a significant PFS benefit. Not only will it need to show a significant OS benefit to compete at all with KEYNOTE-407 results, it will be up against a pembro juggernaut, with multiple positive trials and an increasingly powerful narrative of benefit in many NSCLC trials.

quotes

Reply

Thomas Marsland, MD (Posted: May 17, 2018)

quotes

Being still relatively new to the west coast I can comment that the topic of medical marijuana has certainly come up more here than in Florida (although it did come up for discussion there also). I second the comment about the lack of control data. There really is a dearth of clinical studies to support widespread use. With that said there are great anecdotal stories to support benefit from its use. One other problem is the quality control from the production and distribution. How much of the active cannabinoid are present and in what proportions? I did have the opportunity to attend a pain conference last year and there was a presentation on medical marijuana. Indeed there are a number of cannabinoid receptors within the CNS and it certainly would be interesting to see good scientific research looking at efficacy correlated with markers and outcomes. Hopefully this will come one day but until then we will just have to continue to rely on the anecdotal information. It clearly works for some patients.

quotes

Reply

H. Jack West, MD (Posted: May 17, 2018)

quotes

It looks like we're going to have data from the IMpower150 trial released in small bits every few months, without any new electrifying developments. Here, the most notable finding is the hazard ratio for OS of 0.54 among patients with an EGFR mutation or ALK rearrangement who received carbo/paclitaxel/bevacizumab + atezolizumab, compared to carbo/pac/bev alone. Patients with liver mets also had the same HR for OS of 0.54 with chemo/bev/atezo.

The reality is that the real comparator for the IMpower150 four-drug regimen is carbo/pemetrexed/pembro (as per KEYNOTE-189), and I think for a broad population, the KEYNOTE-189 regimen is more compelling. However, for patients with an EGFR mutation especially, and to a lesser extent those with an ALK rearrangement, the carbo/pac/bev/atezo regimen deserves to be considered as a compelling option AFTER patients have progressed on initial targeted therapy. Importantly, these patients were to have already received an EGFR or ALK TKI, and the IMpower150 approach should not replace highly effective targeted therapy as first line treatment.

We should expect to see far more work on immunotherapy in patients with a driver mutation. One of the most significant effects of IMpower150 will be that it leads to a re-opening of this question, after the data we had in 2nd line NSCLC led most lung cancer specialists to conclude that checkpoint inhibitors don't have meaningful activity in these patients.

Finally, we need to clarify if the benefit requires bevacizumab, which can be answered by seeing how Arm A of IMpower150 (carbo/pac/atezo, no bev) does. That hasn't been reported yet but can help us understand the contribution of the bev component on Arm B.

quotes

Reply

Dean Gesme, MD (Posted: May 16, 2018)

quotes

How does this work? Higher prices in the non-US market are no assurance of lower prices in the US. Are we relying on the altruism that never has existed in capitalist economies??

quotes

Reply

William McGivney, PhD (Posted: May 11, 2018)

quotes

Coincidently, I was lecturing last week at the Home of Guideline study, Dartmouth (at the Tuck Business School). I talked about how studies in the 1980s by Drs Wennberg, Zubkoff, and others argued for the establishment of national guidelines. Why? The goal was to diminish the substantial variation of physician practice and recommendations for different reasons in regions across the country.
Thirty years later, we now have a (dare I say) bastardization of that principal as described in this article. Payers, health plans, MCOs, etc. require their own selected and favorite pathways that may differ across each patient frequently in terms of recommended treatments, including preferred treatments. Oncology practices must juggle multiple, disparate recommendations depending on the insurance that a patient may carry or that MCO picked by a payer to manage that patient.
The circumstance of the multiple guideline/pathways recommendations that oncology practices have to juggle belies the concept of a National Guideline that unifies and directs best patient care. Anybody ever hear of the letters NC?

quotes

Reply

William McGivney, PhD (Posted: May 11, 2018)

quotes

Payer cost-sharing requirements for patients are an anathema, abomination and disgrace all rolled into one. The current story reiterates, yet again, the issue of seriously ill patients delaying or forgoing needed treatment because of cost-sharing terms in their insurance plan. Cost-sharing is such a nice, euphemistic way to describe what is the abhorrence of this insurer patient-gouging strategy. Indeed, as I am wont to ask, is there still really health insurance that protects seriously ill patients from catastrophic events? If there is, it is “slip, slip sliding away” as commercial payer revenue keeps rising.
The solution is legislation that would eliminate on the private payer side and public payer side cost-sharing arrangements such as deductibles, co-insurance, and co-pays for those diagnosed with and battling serious life-threatening illnesses. A list of such illnesses should be delineated that deserve such protection to assure patient access to necessary therapies.
I developed the Terminal Illness program that Aetna instituted in 1992. To establish a solid patient-oriented and humane piece of legislation is a relatively easy “to do”. Then, we can see who truly stands in support of patients! We should move forward as we seek to serve and treat seriously ill patients in need!

quotes

Reply

H. Jack West, MD (Posted: May 07, 2018)

quotes

Though reportedly leading to a statistically significant improvement in overall survival in the IMpower150 trial (per a press release, data yet to be revealed), the carbo/paclitaxel/bevacizumab/atezolizumab combination adds little other than neuropathy and hair loss to the regimen of carbo/pemetrexed/pembrolizumab already approved by the FDA in advanced non-squamous NSCLC. The one finding that was novel and striking about the IMpower150 trial data thus far is that the 14% of patients enrolled who had an EGFR mutation or ALK rearrangement and had progressed on prior targeted therapy demonstrated a relative improvement in PFS with addition of atezolizumab that was every bit as good as that seen in the broader population. In fact, patients with an activating EGFR mutation had a HR for PFS with carbo/pac/bev/atezo of 0.41 relative to carbo/pac/bev alone. This should lead to far greater enthusiasm for using immunotherapy combinations for patients with a driver mutation after they have developed acquired resistance. However, it remains to be seen whether people will favor this particular regimen or possibly extrapolate that this benefit will also be conferred by pembrolizumab added to carbo/pemetrexed.

I think the most important thing the IMpower150 trial will end up doing is changing our perspective on the role of immunotherapy in patients with a driver mutation. We have much more to learn about this question.

quotes

Reply

H. Jack West, MD (Posted: May 03, 2018)

quotes

An important result, one more piece of evidence that is at least somewhat supportive of the idea of giving concurrent immune checkpoint inhibitor therapy with first line chemo. This trial is very similar to the IMpower131 trial of carbo/nab-paclitaxel or paclitaxel with atezolizumab or placebo, which has been reported in a press release to be positive for a significant PFS benefit.

We will see more info at ASCO 2018 on these studies. Importantly, however, in a setting in which we're giving up a line of treatment by moving a previously second line approach into first line, seeing more transient, less important endpoints like PFS or especially response rate improve is not nearly as impressive as seeing these potential changes in practice translate to a significant improvement in overall survival. I personally won't favor adding intensity of treatment, cost, and toxicity to the burden of a line of therapy unless it produces an improvement in OS or a dramatic improvement in PFS, such as 6 months or more, ideally without much of an added toxicity burden.

quotes

Reply

Thomas Marsland, MD (Posted: May 02, 2018)

quotes

So some thoughts to share upon reading this review.....there is one comment on Flatiron and Bristol using real world data to form a "virtual" control on a small study of Opdivo in esophageal cancer. This is at least somewhat troubling, for several reasons. First, the gold standard still needs to be the randomized prospective trial. Secondly, it is bothersome that the folks who control the data are determining what and how the control arm is being selected. I am also worried about industry collecting and controlling the data and how it is used. Rules for transparency and conflict of interests need to be more clearly defined. Finally, where do the patients and physician fit into all of this? Data are collected via flatiron's EMR which is being used in practices; what control over the data accumulated do the doctors and patients have??? In today's world of mergers, as pharma controls data, insurers, drug distributors, and information companies all start to come together. Where is the transparency and who is looking out for the patients interests?

quotes

Reply

Thomas Marsland, MD (Posted: April 24, 2018)

quotes

Clearly the risk for a drug payment bundle could be prohibitive. The variation from practice to practice, or even doc to doc can be significant. Not all cancers were created equal. Even just in breast cancer the differences between someone who treats hormone positive cancer can be dramatically different from someone who treats Her-2 positive or triple neg patients. As one of the authors pointed out the current ICD10 system makes if very difficult to differentiate these sub categories. Historical utilization and risk stratification could be helpful. If someone treats a higher risk population then their "profile" would reflect that and appropriate adjustments could be made. The usage of disease pathways might also make it easier to predict drug cost and bundling. Finally there should be exceptions for outliers. When the DRG system was first introduced to the hospitals, there was a mechanism to deal with outlier populations. Although there really is significant risk there may be a solution if some of these ideas were considered.

quotes

Reply

Howard Sandler, MD, MS, FASTRO (Posted: April 24, 2018)

quotes

Interesting experience using focal radiation techniques (with injected radiation) to treat HCC. There are many focal ablative treatments in the liver cancer space including chemoembolization, RFA, cryotherapy, external beam stereotactic radiation approaches. Important for us to improve these techniques as the HCC problem continues to grow! It would be nice to see comparative studies between techniques to help define relative advantages and disadvantages.

quotes

Reply

H. Jack West, MD (Posted: April 24, 2018)

quotes

This is a disappointing result, particularly considering how low the bar is to beat third line standard of care in advanced NSCLC, and in the context of so many positive trials of immunotherapy in other lung cancer settings. Moreover, this report should only further lower our expectations for the MYSTIC trial with this combination in first line NSCLC (if that's possible at this point) and I think causes some collateral damage to nivo/ipi as another PD-L1/CTLA-4 inhibitor combination that is "on the bubble" in terms of how to interpret the data thus far.

Perhaps the results would look convincingly more favorable if AZ were to focus on a molecularly defined subset, as BMS morphed the recent CheckMate 227 AACR presentation and publication into a focus on patients with high tumor mutation burden. Regardless, this is unwelcome news for a checkpoint inhibitor strategy several steps behind others in NSCLC.

quotes

Reply

H. Jack West, MD (Posted: April 19, 2018)

quotes

This will be a welcome addition to our very limited armamentarium for small cell lung cancer. This is a setting in which topotecan is approved, but I don't think there's another approved agent in oncology less enthusiastically endorsed in practice. It's activity is very marginal, toxicity is significant, particularly if administered as it was actually approved, at a dose that is extremely prone to prohibitive myelosuppression.

Based on these issues, those who treat relapsed small cell lung cancer have eagerly awaited ANY viable alternative. Though only a minority of patients respond well to nivolumab, the same can be said for topotecan, but nivolumab is typically associated with far more manageable and modest toxicities, and there is a real chance for a more sustained benefit than we could ever anticipate with more conventional chemotherapy. Notably, nivolumab is already listed as a leading consideration in the NCCN guidelines, but it would be very welcome to have a formal FDA approval for nivolumab in this setting. We can also look forward to far more clinical data on nivolumab +/- ipilimumab in SCLC in the coming years.

quotes

Reply

H. Jack West, MD (Posted: April 19, 2018)

quotes

A long overdue approval that most lung cancer specialists should have come shortly after presentation of the FLAURA trial comparing first line osimertinib to "standard of care" first generation EGFR TKI (either gefitinib or erlotinib) in systemic therapy-naive EGFR mutation-positive NSCLC. The PFS benefit was very substantial (median 18.9 vs. 10.2 mo, HR below 0.5), and osimertinib also has much greater CNS activity to control the risk of future brain mets (quite common in EGFR mutation-positive NSCLC) and also has a more favorable toxicity profile.

Though some oncologists and patients will invariably want to hold out on osimertinib and "save" it as a second line therapy to preserve a backup option, that's an erroneous approach, I would content. If it's reserved for later, a maximum of only 50-60% of patients who develop T790M-positive acquired resistance will qualify for it, and only a limited subset of those patients will actually undergo testing to find it. If osimertinib is used as first line therapy, 100% of eligible patients will receive the benefits from it. If it is reserved for second line, likely well under 50% and more like 30-40% of initially eligible patients will ultimately receive it. Overall, the population will likely to far better by starting with osimertinib.

quotes

Reply

H. Jack West, MD (Posted: April 13, 2018)

quotes

This is a very interesting contribution. We know the response rate to first line EGFR TKIs is 70-80%, but not 100%, and we also see wide variability in how long patients go without progression on initial EGFR TKI therapy. Though we have long oversimplified by presuming that patients with an activating EGFR mutation won't have any other relevant mutations, we are beginning to see that additional mutations may contribute to the variability in outcomes we're seeing.

It will be great to see further work from other sources corroborate these observations, but this is very provocative.

quotes

Reply

Dean Gesme, MD (Posted: April 13, 2018)

quotes

There is no quicker way to "burn out" physicians than to put them "at risk" for expenses that they cannot reasonably and fairly control -- such as drug prices!

quotes

Reply

Thomas Marsland, MD (Posted: April 11, 2018)

quotes

This article really hit home with me. As I have transitioned through my career I've had to deal with many changes in the healthcare system. But the one that pisses me off more than any is the delays in diagnosis and treatments in today's health delivery system. I frequently tell my patients that no cancer grows so fast the 1-2 weeks are critical. BUT in today's world that one to two weeks can easily become six to eight weeks from my ordering studies or treatments till the patient actually receives the service. The bureaucratic hurdles that we providers and patients have to jump through to get the appropriate studies or therapies is criminal. I recently read COA is on the hill
maybe something good may come in this era of less (sic) regulation.....

quotes

Reply

H. Jack West, MD (Posted: April 09, 2018)

quotes

**Practice-changing result**!

We obviously need to see the data, but this large phase 3 trial now demonstrates a significant benefit in overall survival for pembrolizumab monotherapy relative to conventional platinum-based doublet chemo as first line therapy for patients with advanced PD-L1 positive (1% or greater PD-L1 expression) squamous or non-squamous NSCLC. Pembro monotherapy has been a preferred standard of care, if not THE irrefutable standard of care, for patients with advanced squamous or non-squamous NSCLC that has 50% or greater PD-L1 expression, which is about 28-30% of patients. These results extend that approach to somewhere in the range of 2/3 of patients with advanced NSCLC.

The leading competition, at least for patients with non-squamous histology, will almost certainly be the concept of chemo/immunotherapy with carbo/pemetrexed/pembrolizumab, as has been shown to be positive for a significant PFS and OS benefit in the phase III KEYNOTE-189 trial being presented at AACR 2018 on 4/16. This was regardless of PD-L1 status so is likely going to be a very compelling option for patients with PD-L1 less than 1%. For those who are PD-L1-positive, pembrolizumab monotherapy would generally be favored based on the tolerability/therapeutic index, but we'll need to see the actual data for both of these trials before drawing firmer conclusions.

Exciting times!

quotes

Reply

Winston Wong, PharmD (Posted: April 09, 2018)

quotes

CMS has set the reimbursement for their near normal outpatient rate, thus CMS is treating the CAR-T therapies as an outlier, since the normal hospital reimbursement would be based upon the DRG. Given the co-pay cap, there seems to be little margin for the institution. Need to watch can see what will happen with the additional service reimbursement request.

quotes

Reply

Thomas Marsland, MD (Posted: April 06, 2018)

quotes

So again the "value" question....I share my dear friend Ted Okon's comments about sample size of this study. 31 oncologists in a nation of over 5000 medical oncologist is hardly representative. With that said, value is always problematic. Value to whom?? The patient, the payer, the employer, the provider??? Plus the cost is a constantly changing target. Drugs that were considered horribly expensive may be considered a deal when viewed in light of $500,000 Car-T cell therapy. Organized medicine such as NCCN, ASCO and COA have all weighed in with some suggestions on value. Clearly clinical outcomes, quality of life, and cost are all important in the decision process. I always at least briefly discuss cost with the patient and I suspect most oncologist do. Anyway I suspect this issue will be with us for a long time as I don't see pricing coming down soon.

quotes

Reply

Ted Okon (Posted: April 05, 2018)

quotes

A total of 31 oncologists and only from academic centers, medical centers, and the VA. No community oncologists. Not representative of anything but 31 random oncologists. Not really research.

quotes

Reply

Winston Wong, PharmD (Posted: April 05, 2018)

quotes

Its still comes down to a simple fact. No matter what the cost of a medication is, someone has to pay. Negotiated discounts and copay coupon programs are simply cost shifters, much like the concept of a patient copay.When a discount is issues, someone else is forced to pick up the difference. Even in light of UHC and Aetna declaring that all rebates will be passed on to the member, there is still a discount present. Why not then just charge a lower price?

quotes

Reply

Ted Okon (Posted: April 05, 2018)

quotes

Terrible research. Biased sample (not one community oncologist) and making judgements about where oncologists stand on "value" is completely meaningless. Surprised it was published anywhere.

quotes

Reply

Winston Wong, PharmD (Posted: April 05, 2018)

quotes

From a payer perspective, the CMS approval for coverage means that reimbursement for medicare and medicaid plans are mandated. This does not mean that coverage for the commercial population is mandated. Coverage for commercial members will be based upon the clinical utility study results. If the tests are specific to a drug, and will predict if a drug will be effective or not, then commercial business will follow suit. This is because the clinical utility of the test is sound. Anything beyond this will be suspect, and will undergo much scrutiny. There still need to be clinical justification for coverage. As I have noted in the past, FDA approved indication based upon genomic profiling results will prove to be a challenge for payers, and so far, that has held true.

quotes

Reply

Thomas Marsland, MD (Posted: March 28, 2018)

quotes

This is a good review. The article sums up all the advantages and disadvantages of patient access to clinical data. Early, easy, transparent access are important. The negatives are clearly pointed out. Confusion about path, lab and imaging reports often in very technical wording can be very anxiety provoking for patients. Access to someone who can knowledgeably discuss the finding is critical. This however is often problematic for many reasons. In addition when results are particularly bad I personally do not like having phone discussions; there are somethings that really do need a face to face encounter. This again causes delays and anxiety. As we move through these newer models hopefully these issues will be addressed

quotes

Reply

Thomas Marsland, MD (Posted: March 27, 2018)

quotes

Who says you can't teach an old dog new tricks..... I am delighted to see this NCD. In my practice I have been using more and more NGS. These technologies have allowed me to use a much more personalized approach to many patients with difficult to treat tumors. New cancer with an aggressive clinical presentation now have the option of more targeted treatments. Also patients who have been on treatments for a time have additional choices to help control their cancers. This move keeps in step with the evolving trend of thinking of cancers biologically as opposed to anatomically. It is very encouraging to see the payer community more and more accepting of target therapies across tumor types. The wider usage of Foundation One testing will allow wider access to more effective treatments SO Woof, Woof from an old dog.....

quotes

Reply

H. Jack West, MD (Posted: March 26, 2018)

quotes

OS data are helpful & important, but today the true comparator is carbo/pemetrexed/pembrolizumab, which is already FDA approved, and for which we will see phase III data in the KEYNOTE-189 trial, reportedly positive for PFS and OS, at AACR on 4/16. Unless the carbo/paclitaxel/bev/atezo data look clearly superior to carbo/pemetrexed/pembro by cross-trial comparison (not statistically valid and not recommended, but inevitable when considering options in real world practice), which I think is very unlikely, clinicians will favor carbo/pemetrexed/pembrolizumab based on familiarity and favorable tolerability. My view is that the carbo/paclitaxel/bevacizumab/atezolizumab combination is a fine option but a lateral move except for adding hair loss and risk of neuropathy. I think other IMpower trials that use atezo with different regimens are going to prove more attractive than ones that saddle it with paclitaxel.

quotes

Reply

H. Jack West, MD (Posted: March 23, 2018)

quotes

Obviously a disappointing result, especially in a selected population. Some of my colleagues note that relapsed SCLC is a difficult setting with historically poor results and remain open to rova-T still having a place. I agree that a minority of patients have good responses, but the response rate even in this molecularly selected group was a mere 16%, with a median OS under 6 months, and even a lousy median duration of response of just a few months in the patients who did respond.

In my view, even if this agent is marginally helpful, it isn't close to worth what a new targeted therapy will cost, which is probably an average of at least $10-15K/mo of response that the few responders will experience. I don't think Abbvie or anyone else will have the perseverance or budget to sift through the wreckage and throw good money after bad to develop this further, at least not in this indication.

quotes

Reply

Thomas Marsland, MD (Posted: March 21, 2018)

quotes

As a still somewhat new practitioner in California, I have seen a much broader use of "medical marijuana" than what I was used to before. The patients seem more open to its use and at least from my personal experience they do seem to benefit. As the article suggests, my patients use it for a wide variety of reasons including: pain control, anxiety, nausea, appetite, fatigue and malaise. Clearly it works for many. I had the opportunity to attend a pain conference recently and was greatly impressed with research being done on neuro receptors and how there are multiple different cannabinoid receptors. We are now at a point where clinical trials are called for to look at the effectiveness of cannabinoids in a truly clinical manner. Which cannabis products are most effective in individual clinical cases? How does route of administration play into their effectiveness? Just for the record (since recreational marijuana is also legal in CA), my person drug of choice is a good Napa cab.....

quotes

Reply

H. Jack West, MD (Posted: March 20, 2018)

quotes

This phase III trial of patients with advanced squamous NSCLC randomizes to first line carbo/paclitaxel/atezolizumab vs. carbo/nab-paclitaxel/atezo vs. carbo/nab-pac alone. The press release notes that carbo/nab-pac/atezo vs. chemo alone shows a significant PFS benefit, OS not significantly superior at this interim analysis.

I'd say this is good but expected based on the trend we've seen that the benefits of chemo/immunotherapy first line are not clearly that regimen-specific. However, while the IMpower150 trial (using carbo/pac/bevacizumab/atezo and shown superior to carbo/pac/bev in advanced non-squamous NSCLC) and this trial show a PFS benefit, we've learned that KEYNOTE-189, of cisplatin or carboplatin with pemetrexed + pembrolizumab or placebo in non-squamous NSCLC, is positive for both PFS and OS (results to be presented at AACR on 4/16). In my opinion, KEYNOTE-189 sets the bar for clear change in practice by achieving an improvement in OS. With greater potential toxicity by giving chemo and immunotherapy together, and with a well-established OS benefit giving sequential immunotherapy in the second line setting, I don't think a PFS benefit alone is sufficient to lead oncologists to embrace a treatment approach that eliminates a line of therapy and is more complex and potentially toxic, especially since squamous NSCLC patients are often older and have significant comorbidities.

quotes

Reply

Dean Gesme, MD (Posted: March 19, 2018)

quotes

This NCD creates a bit of a conundrum for commercial insurers; do they follow CMS or try to analyze and promulgate their own rules in this dynamic and turbulent area of oncology? Watch this play out in many and varied ways over the months ahead.

quotes

Reply

H. Jack West, MD (Posted: March 15, 2018)

quotes

This presentation of data from KEYNOTE-189, CheckMate-227, IMpower150, and some other trials of immunotherapy combinations in first line advanced NSCLC will be in the same blockbuster session on late Monday morning at AACR. This two hour period will likely have a significant impact on lung cancer practice this year. All eyes interested in the field should be watching around that time.

quotes

Reply

Winston Wong, PharmD (Posted: March 15, 2018)

quotes

We are seeing a number of mail-in genetic tests being made available. I doubt that payers will cover the cost of these test, for the reasons noted intros piece. In most cases, the patient will take the results to their doctor, who will mostly rerun the test with a commercially available accepted test. It is this test that the payer will cover simply because the conditions in which the test sample was take is controlled, it is definite that the person being reported on, is the person would actually completed the test, and the results have shown utility and trust. Is 23 and Me just riding the ancestry wave?

quotes

Reply

Winston Wong, PharmD (Posted: March 15, 2018)

quotes

This article clearly points out the one area where "charges" has a major impact from a member liability standpoint. Out of Network non-coverage, or even balance billing is the one motivator to drive patients to stay "in Network". Of course, then the uninsured is the most vulnerable, with no coverage at all. However, when services are provided by an in-network provider, charges are meaningless.

quotes

Reply

Winston Wong, PharmD (Posted: March 15, 2018)

quotes

The industry is definitely undergoing a major shakeup, and what falls out is anyone's guess. One would think that with the health plan and the PBM being joined at the hip, there would be a more integrated approach to managing patients. This is true of the UHC/Optum fully insured business, although clear improvement in outcomes have not been shown to my knowledge, It will be interesting to watch who becomes the controlling party here in terms of driving the formulary decisions and strategy.

quotes

Reply

Thomas Marsland, MD (Posted: March 14, 2018)

quotes

Drug pricing and the costs of medications is clearly an ongoing problem. But as always, this report puts the blame on the oncologist. First and foremost, we the physicians do not control drug prices. That falls on pharma. The margin that oncologist make is really just a very small piece of the overall drug costs. The author picks on two specific drugs in this article, but really fails to look at the total drug revenue to practices. There are many drugs that are actually money losers at the current pricing program. In the end, at least at Medicare reimbursement rates, drugs overall are at best a pass though. The private practice of medical oncology is not a non-profit business, although we compete with non profits who clearly have been shown to make much larger "profits" though the widespread mis-uses of the 340B program (addressed in many other forums). Practices maintain an expensive infrastructure on infusion suites, admixture facilities, and highly trained staff to provide high quality services at what I might point out is less costly than similar hospital-based programs. So yeah I'm not a charity, yes I look at drug prices, but that is needed to keep the doors open. I am anxiously awaiting the new, better system.

quotes

Reply

Thomas Marsland, MD (Posted: March 14, 2018)

quotes

So the key question asked in this report is "Who's data is it?" That really is the $64,000 question (gee who remembers that show??). Clearly the potential for big data is tremendous. Real world data can drive clinical decisions making. Which treatments are more effective, less toxic, less costly? Real world data can be used for hypothesis generating clinical trials. Where the waters get muddy is when is data is used by industry to promote marketing and drug usage. Also, there is a huge market for this information by the financial world to promote investing decisions. The economic worth of such information is dramatic. So when large companies such as Roche control this data, how is it limited? Who has access?? What if any economic advantage is there to the patients and physician who are responsible for generating (and owning ???) that data. Clearly there is a need for transparency in this data generation. At a minimum the practices and patients should know when their information is being used in collection or "real world evidence."

quotes

Reply

Winston Wong, PharmD (Posted: March 14, 2018)

quotes

It will be interesting to see if payers will reimburse for this test. I doubt that they will, since it is consumer driver, as opposed to provider driven, and time will be needed for payers to gain confidence in the accuracy and reliability of the test, as well as how the information will be handled by the providers. Will the providers simply just turn around an order another test? In additional, with a consumer driven test, can payers even be confident that the test is being used by the same person who purchased the test and would be billing it to the payer. Many questions to be answered.

quotes

Reply

Winston Wong, PharmD (Posted: March 13, 2018)

quotes

Hospitals will charge whatever they want to charge. The real question is what are they paid? Medicare reimburses from the DRG. Most payers will pay something based upon the DRG rate. Very few will pay charges, or even a percentage of charges. yes there are some exceptions, but even then, there are limits. So why do we look at the charge numbers?

quotes

Reply

H. Jack West, MD (Posted: March 12, 2018)

quotes

We will review these data in comparison to the CheckMate-227 trial results expected to be presented in the next several weeks (which will include positive findings for PFS based on tumor mutational burden, but OS results are reportedly still immature, so we can't expect to see OS data), as well as the rapidly growing collection of data on chemo combined with PD-(L)1 inhibitors, most notably KEYNOTE-189. This trial is also expected to be presented soon (at AACR, I understand) and focuses on the regimen of carbo/pemetrexed/pembrolizumab that already has the major advantages of being FDA approved (based on the phase II KEYNOTE-021g trial) and being the chemo backbone most favored by US-based oncologists for non-squamous NSCLC.

There are certainly opportunities to enter the first line advanced NSCLC setting, especially for squamous NSCLC, but nivolumab/ipilimumab will be the first immunotherapy combination to be broadly discussed and show positive data. The durvalumab/tremelimumab regimen will become a relevant regimen if it demonstrates a significant survival benefit, provided that toxicity isn't prohibitive.

quotes

Reply

Jeff Patton, M.D. (Posted: March 07, 2018)

quotes

There are certainly some perverse incentives in medicine but there is a significant literature that community oncologist "who own their own infusion suites" prescribe the same medications even if the financial incentives are removed. There is also published literature, that institutions like the Mayo Clinic that are enrolled in the 340B government discount program where there financial incentives are 40-50% not 6%, prescribe more expensive therapies than their colleagues in the community. Dr. Rajkumar lives in a glass house and should check the facts before impugning others.

quotes

Reply

Dean Gesme, MD (Posted: March 07, 2018)

quotes

I respect Dr Rajkumar's clinical expertise but here in MN we have a 2% state drug tax as well as the federal government's 2% sequester; hence ASP plus 6% is totally illusory. The 1.8% net margin is insufficent to cover drug ordering, wastage, bad debt and pharmacy overhead unless they were being subsidized by 340b rebates! Thus 340b rebates may be the real perverse inducement and not "ASP plus 6%".

quotes

Reply

H. Jack West, MD (Posted: March 06, 2018)

quotes

With the evidence on immune checkpoint inhibitors in many cancer settings being highly comparable, practical issues like interval between treatments and cost become the leading points of differentiation. An approved four week dosing schedule will lead me to favor this for a larger proportion of my patients moving forward.

quotes

Reply

Thomas Marsland, MD (Posted: March 01, 2018)

quotes

Billing and payments for medical services are a complex, confusing world. There are billed charges which have no bearing on reality. Providers, both hospitals and practitioners, often have charges that are astronomical. No one expects to get "billed" charges. Private payers have contracts which define what they will pay for a given service. Patients are responsible for what their policy requires in terms of co-pays and deductibles. Medicare has fixed fee schedules (price controls ??) with patients responsible for 20% of the allowable on the part B side but 20% of charges on the part A side. So this is where this report hits home. In the hospital setting the amount patients pay may very well vary by huge amounts depending on hospital Part A charges. Agree that there clearly needs to be at least more transparency in terms of patients' payment and possibly some legislation to standardized charges for a given procedure or service. All of which really has little to do the the real, true cost of providing these services.

quotes

Reply

William McGivney (Posted: February 22, 2018)

quotes

I do not what they call it today, but remember the Buzzwords, “Rapid Heath Learning” (RHL) from about 7 years ago. That term came and went fairly quickly; as such terms are wont to do. There were many terms prior to RHL and I would expect that there are many Buzzword terms still to come.
Getting away from semantical genre to the developing realization from Roche that has sequentially purchased Genentech, Foundation Medicine, other diagnostic entities, and now Flatiron (Flatiron purchased Altos Solutions EMR in 2014), the development and utilization of drugs/biologics will continue the march to the application of:
1. Real World Evidence (RWE or aka data) to expand indications
2. to support drugs/biologics in combination
3. to enhance hypothesis generation to identify new biomarkers for drugs and biologics (old and novel)
4. to develop the innovative drugs and biologics that target newly identified biomarkers

There is more but the strategic path is clear. Questions lurk such as:
1. When will the data source, quality, diversity, quantities, specificity, accuracy, recency etc. be sufficient to support the applications listed above?
2. Is the selected EHR sufficiently operable across systems for centers and larger practices to be happy to participate and provide data?
3. How and will the real owners of data (i.e., patients, providers) participate and share in the next $1.9 billion windfall?
4. What are the missing pieces or upgrades that are still needed?

I do not know but it will be great to watch as “evidence-based medicine”, “outcomes-based decision-making”, “rapid health learning”, etc. actually comes to fruition in the competitive private sector!

quotes

Reply

H. Jack West, MD (Posted: February 22, 2018)

quotes

These data are remarkably impressive and are sufficient to lead to a new standard of care. I hope we see an FDA approval to lead to broad testing for TRK and use of larotrectinib being broadly adopted as optimal treatment for these patients.

quotes

Reply

H. Jack West, MD (Posted: February 20, 2018)

quotes

Though we haven't yet seen a significant overall survival benefit with maintenance durvalumab after chemo/radiation, I believe the very significant and sustained PFS benefit are extremely likely to be associated with an OS benefit at least at 2 and 3 years out, but may or may not lead to more patients cured. If we see no patients cured and patients can do just as well being "rescued" with immunotherapy upon relapse, and we can spare some patients already cured by chemo/radiation to receive prolonged immunotherapy, there won't be a clear benefit to giving everyone immunotherapy automatically. We will need to see the long-term results of the trial and whether long term OS is better from a year of durvalumab.

In the meantime, we are left considering whether to change our standard based on PFS alone. I think the potential harm to thousands of patients in the next few years, by withholding a therapy that has a significant chance of improving survival, is greater than any harm that could theoretically come from giving durvalumab based on a tremendous PFS benefit, even if it doesn't improve long-term cure rate. Durvalumab will be my standard of care in this setting while we wait for more mature data from the PACIFIC trial.

Please see my video for further thoughts:
http://traffic.libsyn.com/force-cdn/ec/beacon/BMIC-024_Durvalumab_Stage_III_NSCLC_Standard.mp4

quotes

Reply

Winston Wong, PharmD (Posted: February 19, 2018)

quotes

I lived through and was part of the payer process for many years. It is not a perfect system. It is a system developed for population health management. Unfortunately, the process for those falling outside of the population is not a smooth process. I venture to say that the time frame referred to here was a couple of years ago when genomic signatures were still up and coming. The mere fact that it was paid for is notable. Unfortunately, dealing with the results is not notable. Hopefully today, the test are more readily paid for and the results are believed.

quotes

Reply

Winston Wong, PharmD (Posted: February 19, 2018)

quotes

Once the biosimilars are out on the market here in the US, it will be the first test of how confident the oncology community will be with the use of biosimilars. From a payer perspective, they are not interchangeable, and the Oncologists will have some clout to help drive the market, especially of the financial incentive is not large enough to motivate the switch to the biosimilar.

quotes

Reply

H. Jack West, MD (Posted: February 15, 2018)

quotes

On its face, the report that a trial of avelumab vs. docetaxel in chemotherapy-pretreated NSCLC seems surprising unless it's a clearly inferior checkpoint inhibitor to the ones that have already demonstrated positive results and similar efficacy in very similar trials -- namely nivolumab, pembrolizumab, and atezolizumab. We have presumed that these agents are all far more similar than different.

The JAVELIN Lung 200 trial did note that the cross-over of such a higher proportion of patients to subsequent immunotherapy in this trial (26.4% on docetaxel arm, vs. 5.7% on avelumab arm) vs. other ones that have been positive is likely to be a relevant factor that compromised the ability to detect an improvement in OS in the broad study population. Frankly, I think it's disappointing that only just over 25% of patients received access to clearly very effective immunotherapy that has been a standard of care now for a few years. In my clinic, nearly 100% of patients who were ever eligible for a checkpoint inhibitor receive it over the course of their illness. The only question is whether it is delivered first line, second line, or later. And while this trial was conducted in a different time and place, the evidence should lead us to conclude that only 26% of patients receiving immunotherapy is gross under-treatment.

It is also notable that the effects were reportedly greater in those patients with high level PD-L1 expression, as we've generally seen, with a positive survival benefit in that subset.

We will need to see the actual data in an upcoming meeting, but I believe that it is premature to conclude that avelumab is a less effective therapy than the similar checkpoint inhibitors that have been approved in this setting already. I think the results may be most instructive in demonstrating that the timing of immunotherapy is not critical for many/most patients to achieve the same overall survival. In the contemporary practice of treating lung cancer, we should expect and aspire to have nearly all eligible patients receive one of these agents at some point over the course of their disease.

quotes

Reply

Winston Wong, PharmD (Posted: February 14, 2018)

quotes

Unfortunately, this is reality. All of these tactics are being used to delay the release of generics. Holding back the reference product is a big thing in the biosimilar world. Recall it was not so far back that we heard of lawsuits files against the innovator companies for paying the generic manufacturer to delay their release. The only thing different today is that with the release of the generic, especially the Revlimid, the generic might not be that less costly. Keep in mind that only a 10% break in cost will support a generic designation.

quotes

Reply

Winston Wong, PharmD (Posted: February 14, 2018)

quotes

Medication Therapy Management programs have proven that they can improve patient compliance and adherence. Having a program focused on oral Oncology drugs is needed. My only concern is that for years, MTM programs have been promoted. In the real world, MTM program have failed, especially in the chain pharmacies due to the lack of time available to talk to the patient. Time allocation and productivity measure for the provision of MTM services have not been integrated into the pharmacy workflow. Hence, is frequently neglected. Yes the pharmacist asks if there are any questions. If the patient responds affirmatively, prescription filling slows down, especially if the medication is an oral oncolytic. So while I applaud Walgreens for developing a patient support program, I question if it will actually be put into place on a widespread basis.

quotes

Reply

Thomas Marsland, MD (Posted: February 12, 2018)

quotes

YEA!!! Occasionally Congress can get it right. Hey, even a blind squirrel can find an acorn now and then........

quotes

Reply

Dean Gesme, MD (Posted: February 11, 2018)

quotes

Increasing transparency in drug pricing and total costs of care attributable to drugs can only serve to foster greater intelligence and insight into the use of pharmaceuticals in the US.

quotes

Reply

Thomas Marsland, MD (Posted: February 08, 2018)

quotes

There is a lot beneath the surface in this report. Clearly the major factor in the growth of hospital practices is the 340B program but it is clearly not the only factor. The point is that whether an institution participated before or after 2010, those 340B facilities have a definite competitive advantage over community private practice. Hospitals, whether 340B or not, also have a higher compensation for the exact same service provided under the OPPS compared to the physician fee schedule that private practices bill under. Many also charge a facility fee that private offices cannot. In addition to the expanded revenues afforded hospital centered practices, the bottom line revenues in private practices has deteriorated due to ASP and the multitude of new rules, regs, and other requirements foisted on private practice by the payer communities. The shrinking revenue in private practice has driven doctors to the hospital settings where doctor compensation may be better and there is less hassle with the day to day running of a practice. So as the author suggested it is not solely due to 340B issues that we are seeing the death of private practice but it surely is one of the major drivers. Will be interesting to see how the new reduced payments under the 340B program effect this migration.

quotes

Reply

William McGivney, PhD (Posted: February 06, 2018)

quotes

One tweet struck me in this story about the update on Amazon, JP Morgan and Berkshire and it is:
• “I want there to be something to bring healthcare costs down.”
Well, as a whole, general health care costs will never come down as I have written over the years. Healthcare technology innovations are always expensive. Many of these technologies turn out to be add-on interventions (monotherapy going to combination) or make more lines of therapy available by becoming first line (like anti-PD-1s and anti PD-L1s) pushing down previous first line agents to second line and then others to third line, etc. Importantly, our population of potential patients continues to get older.
Actually, the most insightful comment came from Dr. Warren Buffet (honorary MD for my convenience) as the quote focused on working to “check the rise in health costs”. As such, whoever wrote the quote understands that the goal is to check or slow the rate of rise of healthcare expenditures. This is the best that we can hope for and aim for.

quotes

Reply

Thomas Marsland, MD (Posted: February 06, 2018)

quotes

So maybe they really are smarter than the rest of us and can provide better care at a lower cost. Certainly these are highly successful, powerful companies and if they really leverage their strengths and resources perhaps they will be able to accomplish their goals. I'm not sure that the "free from profit making" is going to be the answer since there still will be huge costs in providing care. They claim that with the number of employees they can develop "cost effective ways" to deliver care. Gee, the rest of us have never thought of that....Clearly cost and value are hard to define and have different meanings to different stakeholders. As we all struggle to provide more cost effective care I am struct by how much harder it is to deliver good care because of all the rules, regulations, and requirements that delay access to the care patients truly need. One step in the right direction these companies are exploring is to get rid of the hugely expensive middle man, the payer. Payers have large bloated overhead that increase cost of care tremendously. If these successful companies can bring the ability to coordinate care through more efficient information systems which they have used successfully in their other operations, perhaps this will result in a reduction in cost without loss of quality care. If their systems can eliminate many of the problems experienced by doctors and patients who struggle daily with non inter-operative, inefficient information systems, that would certainly go a long ways towards obtaining all our goals of a better health delivery system. So I guess we will find out.

quotes

Reply

H. Jack West, MD (Posted: February 05, 2018)

quotes

We’ve eagerly anticipated results from the CheckMate-227 trial, an open-label phase 3 trial of over 2500 patients with advanced NSCLC, either squamous or non-squamous histology, randomized to nivolumab monotherapy or in combination with ipilimumab versus platinum doublet chemotherapy in a comparison of patients with tumors expressing PD-L1 (any level, by the 28-8 pharmDx assay) on part 1a or with tumors expressing no PD-L1 on part 1b. The press release today reflects results for both groups on part 1, noting that there was a significant improvement in progression-free survival (PFS) with nivolumab/ipilimumab (nivo/ipi) compared to platinum doublet chemotherapy in the subset of patients with high tumor mutation burden (TMB) defined as >10 mutations/megabase (mut/MB) on the FoundationOne CDx assay (a liberal threshold capturing approximately 40-45% of patients), though FoundationOne defines high TMB as >20 mut/MB (representing only approximately 13% of patients) (hat tip to Andre Sawyer, Analyst for Equity Research, for noting this point that is easy to overlook). This positive result in patients with high TMB was independent of PD-L1 level. These results are provocative, though we clearly need to see the actual data to get a better sense of the clinical implications. In the meantime, however, we can draw some preliminary conclusions.

First, this result adds momentum to the mounting evidence supporting TMB as a relevant biomarker. It is necessary to add the caveat that this was not a prospectively identified endpoint, as well as the fact that this particular threshold of defining high TMB differently than is done by Foundation Medicine undermines some of the convergence toward clinical utility of TMB if there is no semblance of any consensus. Moreover, we should hope and expect to see subset analyses that define whether the results are far stronger in the much smaller subset with the 20 mut/MB cutoff, with the results in the broader population defined by a 10 mut/MB cutoff diluting the effect but expanding the population to be considered good candidates for nivo/ipi. We should ensure that the lower threshold truly defines the group most likely to benefit from nivolumab/ipilimumab and isn’t being promulgated as a reverse engineered result to maximize eligibility while still defining a population in which the positive result for PFS is maintained.

Second, I consider a positive effect for PFS to be encouraging but insufficient to change practice unless the absolute difference is absolutely remarkable, particularly in the non-squamous patient population. Despite the FDA approval of the carboplatin/pemetrexed/pembrolizumab combination in May, 2017 based on the phase II KEYNOTE-021g trial, I and many other thoracic oncology specialists, as well as general oncologists, have remained unconvinced that the improvement in response rate and PFS with the addition of pembrolizumab to first line chemotherapy should change practice when a sequential approach may well confer the same overall survival (OS). The widening gap between the OS curves with longer follow-up on KEYNOTE-021g has warmed me to this approach as an increasingly compelling option, as has the recently reported positive results for a PFS and OS benefit with addition of pembrolizumab to cisplatin or carboplatin with pemetrexed in the phase III KEYNOTE-189 trial (actual data still awaited). With a regimen that oncologists are comfortable using and that is FDA approved, carboplatin/pemetrexed/pembrolizumab will be the true comparator as we consider nivo/ipi as a challenger.

In contrast, we don’t yet have a first line immunotherapy-based treatment approach for patients with squamous NSCLC who don’t have a tumor with high PD-L1 expression (for which pembrolizumab monotherapy is a clear standard of care and strong option). I think for patients with high PD-L1, pembrolizumab will remain a leading option, and nivo/ipi may emerge as a favorable option compared to doublet chemotherapy for patients with high TMB and low or negative PD-L1. We will need to see the magnitude of benefit and tolerability of nivo/ipi when the actual data are available. In addition, we should expect to see several trials of chemotherapy combined with checkpoint inhibitors in patients with squamous NSCLC that may well be positive for PFS and/or OS in the next 6-12 months. These options will need to be considered alongside nivo/ipi.

Though the dose and schedule of nivo/ipi may well be tolerable for a broad population, it will be critical to see the toxicity profile and compare it not only to a platinum-based doublet but to that expected for other alternatives. I remain concerned that nivo/ipi may be challenging for less selected, potentially older and sicker patients, being treated by oncologists with less support and experience than the trial investigators who have been the main ones gaining experience with this combination up to this point.

Overall, I think this is encouraging for adding further credibility to TMB measurement and potentially nivo/ipi for a selected subset of patients with advanced NSCLC, but I feel these results should definitely not lead us to adopt either TMB or nivo/ipi in clinical practice without far more information.

quotes

Reply

Thomas Marsland, MD (Posted: February 01, 2018)

quotes

I think this is a good release. It really is time for a good shout out to NCCN. I would like to thank them for their great work. I find their guidelines a great help. As a community oncologist who sees all types of cancers daily, having a resource like NCCN allows me to feel comfortable treating most cancers. As the article stated, I do visit the site much more frequently. Often the guidelines just reassure me that I am not so out of date as I fear but they do also keep me abreast of rapidly changing treatment protocols in a world where it seems we are often seeing a new drug approval daily. So again thanks NCCN!

quotes

Reply

William McGivney, PhD (Posted: January 31, 2018)

quotes

An intriguing announcement was made this morning in that Amazon, Berkshire Hathaway, and JP Morgan will establish a joint venture to reduce health care costs and to improve services for their US employees.

In this “Value” era of evaluation and valuation of health care stakeholder contributions to patient benefit, the establishment of this joint venture by these three industrial behemoths signals the initial recognition of counterpart managed care behemoths’ failures not just in reducing costs but not even substantially restraining the rate of rise of health care expenditures. The real story is that in the Value paradigm, payers and managed care organizations across 25 years have failed and, in their failures, actually have extracted billions of dollars in return from the health care system. Truth be told is that “Value” is lacking in the billions of dollars extracted and generated in redundant, frustrating utilization management programs, formularies, step therapies, precertification requirements, prolonged appeals processes, incomplete and late coverage policies, patient cost-sharing, etc. Please just look at company SEC filings where these words are translated in to dollars. The bottom line is that payers and managed care companies actually have achieved negative (harm) patient benefit both to patients and to self-insured employers.

Self-insured employers, like the three cited, have long suspected that the money paid out for the aforementioned UM programs have been relegated to black holes sucking dollars into them with the impossibility of definitive mapping of where the money went (e.g., medical costs column) and great uncertainty regarding the effects of the programs such dollars funded.

Generally, the “Big 5” commercial insurer stock prices fell 3-5% on Tuesday on the Dow. I guess investors agreed that a techno company, a bank/investment house, and another investment house possibly could manage health care more effectively and efficiently than health insurers, PBMs, SPs, etc. The easiest initial way to cut costs would be to delete the onerous UM and like programs foisted on the system and on clinicians and patients!

Finally, in a somewhat serious ask: Do we really need payer coverage policies with all the available guidelines, pathways etc? Again, as a senior insurer health lawyer said to me as she/he was leaving the company: “The best thing is that I will not have to say any more that Insurer X does not make medical decisions!"

quotes

Reply

Ted Okon (Posted: January 29, 2018)

quotes

So great to have community oncology stateside help cancer patients and their medical providers bounce back after the devastating hurricane.

quotes

Reply

Ted Okon (Posted: January 29, 2018)

quotes

New study from Avalere Health shows the real impact on hospitals of CMS rebalancing 340B program. Vast majority of hospitals will get a Medicare payment increase, on average. Rural hospitals really benefit. A lot different picture than the one-sided misinformation on this topic.

quotes

Reply

Winston Wong, PharmD (Posted: January 28, 2018)

quotes

The benefits, both clinical and financial, of patient navigation programs is slowly being realized. Payers to date have been slow to realize the value of a program like this. Horizon has been on the cutting edge of many program, and this can now add Patient Navigation to their list.

quotes

Reply

Winston Wong, PharmD (Posted: January 28, 2018)

quotes

We have been making the same plea for Head-to-Head studies for years. Managed Care has suggested it be part of the FDA approval process, which is what lead to the development of the the CER process. This falls short of being a requirement for the approval process. The FDA position is that they evaluate a medication for efficacy and safety. Cost is not a part of the evaluation, and neither is comparative effectiveness outside of a comparison to a "standard" treatment.

quotes

Reply

Howard S. Hochster, MD (Posted: January 22, 2018)

quotes

Great work by Mike Overman and colleagues showing prolonged benefit to Nivo (3 mg,kg) and Ipi (1 mg,kg) given x 4 doses. Median duration of response not yet reached and over one year. This does suggest the combo is more active than single agent Nivo. But randomized trials are needed in this rare MSI-high population. Now possible in the NRG/SWOG COMMIT trial available on CTSU. Please screen your patients early and consider this for first line therapy. After all, MSI-high patients have great responses to chemo also. Order may matter.

quotes

Reply

Howard S. Hochster, MD (Posted: January 19, 2018)

quotes

The Keynote-224 is only a phase 2 study of good performance, very well selected HCC patients after sorafenib. But with a 16% response rate and 77% 6-month survival (median survival not yet reached), this is unprecedented good news for HCC patients. Median time on study was 8 months, which could amount to a very meaningful extension of life. The main question is whether these results will be seen with a more real-life patient population. But these data confirm what is seen with nivolumab and show a real benefit compared to other options in HCC (e.g regorafenib after sorafenib).

quotes

Reply

Thomas Marsland, MD (Posted: January 18, 2018)

quotes

It will be a while to see how this reduction in the 340B compensation for drugs really plays out. I the article they talk about how the "margin" is used to provide additional services for patients that otherwise would not be available. While this is certainly true that many of the 340 B institutions do provide some additional services they also have rapidly expanded their oncology service line absorbing private practices at an exponential rate. How will the cuts effect that?? Will current programs be cut ??? Will we the physician be forced out or be made to work more for less ??? As private practices have contracted will there even be alternatives for those who may wish to return to a private practice setting. Will hospitals learn to be more efficient as those in private practice were force to do when the ASP pricing went into effect ??? Guess time will tell but it certainly will be interesting to watch

quotes

Reply

William McGivney, PhD (Posted: January 17, 2018)

quotes

There are a few of us out there who will remember the famous Abbott and Costello routine that in continuous circular loops keeps begging the question “Yea, but who is on First?”. Practices and Cancer Centers provide care and treatment but also are business centers with each one generally qualifying as a multimillion dollar business.
For businesses, uncertainty is always a negative. Uncertainty in federal regulation, especially in reimbursement processes, measures and requirements, causes confusion and inefficiency in practice planning and management. The moves (e.g., MIPS, OCM) by the federal government to programmatically transition physicians away from fee-for-service practice to Value-based decision-making have been beset by fits and starts with changes that contravene provider side efforts and practice investment in enhancing practice infrastructure and capabilities.
The latest hiccup or, maybe more accurately, eructation in the sequence is exemplified by the MedPAC’s recommendation that the MIPS program be abandoned because the MIPS “system is too burdensome” for physicians and will not lead to improved care. MIPS cuts across therapeutic areas in American Medicine and, thus is not the main focus in Oncology where the OCM continues to evolve. In OCM, practice sentiment is in some situations turning negative with complaints about quality measures that do not relate well to every day practice, government feedback reporting that is confusing, and feelings that one is just checking all the boxes.
In 2006, there were some discussions with CMS about using NCCN Guidelines as a basis for Quality of Care determinations. There were reasons why this NCCN-based process could not be considered for full implementation beyond being a CMS demonstration project for 2006. But now, given present-day back and forths and uncertainty, something built around the NCCN Guidelines deserves serious consideration. At the least, such a system might provide some relief from the policy routine which is becoming farcical to some and unsettling to others who invest hard-earned dollars in capabilities and infrastructure to satisfy evanescent rules and requirements.

quotes

Reply

Dean Gesme, MD (Posted: January 16, 2018)

quotes

This call for head to head trials of checkpoint inhibitors is spot on. These trials may be necessary in order to avoid a “commoditization” of this class of drugs by payer/provider interests seeking to reduce excessive treatment costs with immunotherapies given the lack of documented clinically significant differences in efficacy and safety within this class.

quotes

Reply

H. Jack West, MD (Posted: January 16, 2018)

quotes

This is a very important result, in keeping with the results of the phase II KEYNOTE-021g trial that led to the FDA approval of the carbo/pemetrexed/pembrolizumab combination that many experts feel was premature, being based on just 123 patients and with only preliminary OS results at the time of the approval. The report of statistically significant positive results for both PFS and OS with initial cisplatin or carboplatin with pemetrexed and concurrent pembrolizumab over the same chemo alone corroborates the KN-021g trial on a larger scale that we really needed to see.

I expect that several other trials that present results this year of various chemo backbones +/- various PD-1/PD-L1 checkpoint inhibitors will also demonstrate a significant benefit at least with PFS and likely many with an OS benefit as well. For patients with non-squamous NSCLC, however, a platinum/pemetrexed combination (overwhelmingly more often carbo than cisplatin in the US) is the preferred chemo combination. Based on this and the existing FDA approval of the KEYNOTE-021g regimen, I believe carbo/pemetrexed with pembrolizumab will be the clear pace-setter for this population. Any competing regimen would need to not just be comparable but would need to be significantly superior to this one in order to provide a real incentive to change from carbo/pemetrexed/pembrolizumab at this point.

That said, there are several important questions that will modulate the level of enthusiasm for this regimen over a sequential approach. Today, the standard of care for the ~30% of patients with high PD-L1 expression (based on 22c3 antibody as companion diagnostic for pembro) is pembrolizumab monotherapy, based on the compelling benefits seen on the KEYNOTE-024 trial, rather than chemo alone. It will be critical to assess whether the results of KEYNOTE-189 are still compelling once that subgroup is removed, because the most relevant question for 2018 is whether patients with low or no PD-L1 expression should receive concurrent chemo/immunotherapy or sequential chemo followed by immunotherapy. Accordingly, the other critical question is whether patients on KEYNOTE-189 who were assigned to initial chemo have a very high crossover rate to subsequent immunotherapy, as they should when 3 checkpoint inhibitors are FDA approved and have a very clear survival benefit in that setting. Though some are complacent and argue that a 60-75% crossover rate to subsequent immunotherapy is sufficient and represents real world challenges, I would contend that those patients who do not receive a checkpoint inhibitor in second line or later have been denied a therapy with proven benefit and have been under-treated by the health care system. More than 95% of my patients who are eligible for a checkpoint inhibitor receive it at some point in their treatment course -- it is absolutely possible. For KEYNOTE-189 to be truly interpretable, we need to see that first line concurrent chemo-immunotherapy is superior to sequential treatment where nearly all patients benefit from both treatment approaches. A lower crossover rate will only demonstrate that 100% of patients receiving immunotherapy is better than only 2/3 of patients receiving it at some point.

Nevertheless, the same could be said for the PARAMOUNT trial's testing of maintenance pemetrexed, which really only demonstrated that the benefit of pemetrexed doesn't max out at 4 cycles, not that it's critical to give maintenance pemetrexed indefinitely. It's a very similar issue here, but we see that our practice patterns in advanced NSCLC have incorporated maintenance pemetrexed as a default because oncologists we will give the heavily marketed message the benefit of the doubt rather than challenge it too critically. I strongly suspect that the evolution of the immunotherapy space in NSCLC will show a similar story and that carbo/pemetrexed/pembrolizumab will be adopted broadly regardless of any lingering questions of whether it is necessarily the best treatment approach for most patients.

quotes

Reply

Winston Wong, PharmD (Posted: January 10, 2018)

quotes

Prior to the "Benefit Exchange" individual market, most states had regulations stating minimal, but essential, mandatory benefit coverage for individual and small groups. Due to the high risk pools in this population, cost ratios were high. Payers had to attempt to manage benefits to minimize losses. Some were aggressive and survived. so if we look back, the model was in place insuring access to care. What came about with the exchange market was that the mandatory benefits were expanded benefit, resulting in a high actuarial cost. Hence, the market blew up. Maybe we need to step back in time to evaluate bringing back a model that may have come closer to being affordable.

quotes

Reply

Winston Wong, PharmD (Posted: January 10, 2018)

quotes

Annual drug price increases is around 7-9% annually. Negotiated Rebates help to counter these increases, but as Mr Fraizer points out, only a small portion benefits the patients directly. What little actually benefits the patient is negated by increases in copays and coinsurances. So maybe the solution is to do away with rebates entirely and move to a straight list price strategy. Then in order to achieve a coverage status, the competition is then convert to a price war. Price wars to lower cost is cleaner and more transparent than todays world of increasing prices, balanced by PBM negotiations to gain bigger rebates, only to have a good portion to go towards their profit margins, and little benefiting the patient.

quotes

Reply

Winston Wong, PharmD (Posted: January 10, 2018)

quotes

Very interesting results. Accurately stated, early analysis of OncoTypeDx showed positive cost effectiveness based upon ideal conditions. There is no argument that real world practices paint a more realistic analysis of cost effectiveness. While early studies did note that a portion of the women determined to have high risk of recurrence opted to skip chemotherapy treatment. They also note, as within this study, that a portion of women determined to have a a low risk of recurrence went on to have chemotherapy. What one needs to question is why did these women opt to undergo chemotherapy treatment. In addition, if chemotherapy was part of the treatment plan, why was the test even completed? Also, if chemotherapy was not a treatment option, why was the test completed. I do not disagree with the findings, as they confirm the findings of early studies (if you dig into the detail). So maybe the true action point here is what can be done to refine the inclusion criteria to run the test in the first place. Maybe tests like OncoTypeDc and Prosigna will become much more cost effective if completed in the appropriate population.

quotes

Reply

William McGivney, PhD (Posted: January 04, 2018)

quotes

As new innovative treatments are advancing to market, it is disconcerting to see that standard treatments such as the radiation component of the combination of chemotherapy with radiation are not being accessed by patients due (still) in part to coverage issues with Medicare/Medicaid. This then raises issues about how coverage policy will keep up today (in 2018) with the rapid advances for the treatment of cancers, including SCLC. The findings of this MD Anderson study are not encouraging!
Years ago in moderating a session, I asked the Chief Medical Officer of Medicare, in a half-serious, half-facetious way, if we really needed coverage policy any more as it seemed to be more hindering of access and availability than facilitating. I think today, I would move the question to being 80% serious.
Coincidently, as I was writing this, I was interrupted by a phone call survey regarding my views of the PBM managing my Part D benefit! Needless to say, questions, such as “how helpful the PBM’ was, were met with responses approaching the nadir of appreciation!

quotes

Reply

Winston Wong, PharmD (Posted: January 04, 2018)

quotes

All good comments made by ASCO, however, I still an a firm believer that while we continue to focus on the providers prescribing, the Opiate issue is bigger than those whom we are monitoring. Just the other day did we read findings of patients continuing to fill opiate prescriptions after there was no need. Granted a prescription should not have been written for 12 months, but the patient still had a responsibility to not fill the prescription. We also have family members that take the opiate meds from other members of their family. And finally, we ultimately have providers and patients working together to maintain the "habit. So while screening programs and guidelines are a step in the right direction, it is not the comprehensive solution.

quotes

Reply

Winston Wong, PharmD (Posted: January 04, 2018)

quotes

Is this a little too late? The average prescription benefit now sees generic dispensing rates in the mid 80's, with the more aggressive plans hitting near 90%. As well, when generics are released, they are being released at a higher cost than what we traditionally are use to. Discounts are not as aggressive these days. Maybe what we need to see is more effort put towards the biosimilar approval process, rather than the analysis paralysis we are now experiencing.

quotes

Reply

Winston Wong, PharmD (Posted: January 02, 2018)

quotes

These 7 Key Trends are definitely a continuation of what we have seen through 2017. From a payer perspective, while the decrease in Chemotherapy is balanced by the increase in targeted therapy is technically true, in the end, the patient is receiving some treatment, which is driving cost. We all will have to deal with how to deal with rising cost. Is value-based payments in the future? Probably yes, but not the near future as we all need to determine a methodology to define value and outcomes. Payers will be put into more of a struggle as the number of tumor agnostic tests increases and payers need to modify their payment policies. And finally, patient outcomes and satisfaction will become part of the "value" equation.

quotes

Reply

Howard Sandler, MD, MS, FASTRO (Posted: January 02, 2018)

quotes

Interesting concept and interesting that it made it thru small business grant all the way to FDA 510(k) approval. Now comes the real challenging part: Is there a market for a breast-cancer specific radiation treatment device?

quotes

Reply

Dean Gesme, MD (Posted: December 20, 2017)

quotes

Tumor heterogeneity is well described but the variability in these NextGen liquid biopsy results seriously calls into question how and when these test results inform best clinical practices for these patients!

quotes

Reply

Thomas Marsland, MD (Posted: December 12, 2017)

quotes

So how many part inhibitors do we need, how many check point inhibitors are necessary? Does every company need a "me too" drug. Clearly the cost of pharmaceuticals is a major problem for all of us. One "experiment" that should be considered is including the price of a new drug as part of the approval process. If a new drug in a given class is truly interchangeable, then as part of the value proposition there should be some cost benefits to the payers and patients.

quotes

Reply

Thomas Marsland, MD (Posted: December 06, 2017)

quotes

So the glass is half full or half empty. Clearly conveying bad news is never easy but honestly is the best policy. Most patient do appreciate the truth but sometime the messenger is killed. It is difficult to offer hope and realistic expectations. In all of the changes to the idea of patient centered care seems that what patients value most is an open and honest discussion of realistic expectations. These types of discussions often require more time and indeed need to be repeated over a number of visits. Going forward the hope is the system will allow for these types of interactions.

quotes

Reply

Howard Sandler, MD, MS, FASTRO (Posted: December 05, 2017)

quotes

PSMA PET and fluciclovine PET are rapidly changing the management of recurrent prostate cancer. Conventional imaging modalities, say bone scan or CT, would only detect recurrences at relatively high PSA levels when local management might be less optimal. However, PET imaging can now detect low volume, low PSA recurrences after surgery that are potentially amenable to local ablation with additional surgery or radiotherapy.

quotes

Reply

H. Jack West, MD (Posted: December 04, 2017)

quotes

On balance, I think this is an advance, as I believe that the lack of certainty about coverage is a significant barrier in getting NGS testing. For cancers like lung cancer, where there are already multiple molecular markers that can be tested individually or through NGS with a savings of limited tissue and potentially cost, there is a clear advantage to efficiency of broader testing. It's less clear that NGS is beneficial for a cancer for which there are not several previously identified markers to evaluate for.

Though we might have some concern about mass scaling of a test costing several thousand dollars per test when there are no data demonstrating that this improves patient outcomes, I think there is more potential for harm based on poor decisions resulting from testing. Specifically, some clinicians may impart too much optimism on a treatment recommended based only on preclinical data and a theoretical benefit. These NGS reports include a wide range of possibly beneficial treatments, but that long tail, in order to justify the cost of the test, very often includes treatments of unclear if not frankly dubious benefit. There is the potential for net harm from the suggested targeted therapies, especially if oncologists and patients discard treatment options that are not individualized and therefore less sexy, but they still have well-established efficacy across broad populations. And there is definitely reason to be concerned that the costs of care will rise significantly because many oncologists will have too low a threshold to administer everolimus, at a cost of more than $10,000/month for every tenuously recommended mutation that could be associated with benefit.

Whether broad molecular testing provides a quantum leap in efficacy of treatment or only its cost will depend on how wisely oncologists use the data that will pour in from this testing.

quotes

Reply

H. Jack West, MD (Posted: December 01, 2017)

quotes

While reassuring to see that the results in a Chinese population recapitatulate those seen in global phase 3 trials with other populations, these results only provide results I would have presumed to be the case. Reassuring, but it wasn't a question I would have had without these data. I have many Chinese patients and haven't hesitated to treat them with nivolumab in the second line setting based on the results of CheckMate-017 (for squamous NSCLC) and CheckMate-057 (for non-squamous NSCLC).

quotes

Reply

Dean Gesme, MD (Posted: November 29, 2017)

quotes

The CMS MIPS program will strongly disfavor oncology practices who must include "buy and bill drugs" in the cost of care provision which is weighed to increase rapidly over the next 3-4 years. APMs may be the only avenue for private practices to maintain "buy and bill" after 2018 unless the MIPS program is changed to remove drug costs from their calculation of MIPS points.

quotes

Reply

Heather (Posted: November 19, 2017)

quotes

Thank you for this article. Working for a genetic counseling clinic for cancer patients and providers, we too agree with the idea of, “Oncology tends to lend itself to multidisciplinary care because of the complexity of treatment.” This also helps patients in receiving more personalized treatment plans.

quotes

Reply

H. Jack West, MD (Posted: November 14, 2017)

quotes

This is interesting and somewhat helpful for turning a clinical observation at the anecdotal level into retrospective data that actually characterize the frequency of this issue in a clinical population. However, we also need to ask what we do with this information. The report indicates that hyper-progression is seen a little more commonly with immunotherapy than with chemo in advanced NSCLC. However, we can't reliably predict who will demonstrate hyper-progression. The authors find that patients with a higher number of metastatic sites have higher risk, but the absolute difference isn't enough to make this a clinically helpful predictor. Given the clear survival benefit with several immune checkpoint inhibitors over chemo in previously treated NSCLC, this information doesn't/shouldn't dissuade an oncologist from favoring a checkpoint inhibitor based on the far more clear prospective clinical trial data.

That said, it's a valuable starting point for further study of this issue.

quotes

Reply

Ted Okon (Posted: November 14, 2017)

quotes

This injunction filed by 3 hospital organizations and 3 hospitals will be interesting to watch. Regardless, 340B hospitals are clearly in the crosshairs of this Administration and Congress. On the other side, the hospitals are fighting mad to retain all the 340B profits available to them. As I have said many times during the past few years, 340B is a financial bubble that has to pop. It is simply not sustainable.

quotes

Reply

Thomas Marsland, MD (Posted: November 08, 2017)

quotes

Certainly the original intent of the 340B program is laudable. Throughout the years the program grew and became subject to along list of abuses. Through numerous loop holes this became a vehicle for hospitals to expand costly cancer programs at the expense of more efficient community practices. This ruling is a welcome first step in helping to save the integrity of the program and its transparency. As the article suggests the patients and tax payers will benefit. Hospitals now will have to compete on a more even playing field with private practices and perhaps will learn some of the efficiency community physician had to learn the hard way when the original ASP rule went into effect.

quotes

Reply

Dean Gesme, MD (Posted: November 08, 2017)

quotes

DIR fees represent an egregious, morally indefensible and obscure business practice that will push PBMs to the edge of ethical and legal acceptability for patients, providers, regulators, and legislators. Be forewarned!

quotes

Reply

H. Jack West, MD (Posted: November 07, 2017)

quotes

The FDA approval for alectinib (Alecensa) as first line treatment for ALK-positive advanced NSCLC is long awaited and should make it a clear standard of care in this setting. The superiority of alectinib over the prior standard of care of crizotinib is remarkable, and alectinib also has highly superior efficacy vs. intracranial progression, which is a common issue in patients with ALK-positive NSCLC. It is also generally quite well tolerated by patients.

Though we still need to learn more about how to best treat patients who develop acquired resistance to alectinib, whether that be with a subsequent ALK inhibitor like brigatinib or lorlatinib (which we hope to see approved in the first half of 2018) or a chemotherapy-based approach, the median PFS for alectinib of over 2 years suggests that we have some time to figure that out.

quotes

Reply

H. Jack West, MD (Posted: November 03, 2017)

quotes

Reading the headline, one might get the mistaken impression that this agent showed clinically meaningful results in relevant endpoints. These results are clinically meaningless and are only instructive for showing how garbage results in bogus endpoints can lead to misleadingly positive results.

quotes

Reply

Winston Wong, PharmD (Posted: November 02, 2017)

quotes

A change is needed. Currently, there is no incentive to use a biosimilar. End of Story.

quotes

Reply

Winston Wong, PharmD (Posted: November 02, 2017)

quotes

There is one subtle, but very real difference in the CVS/Aetna combination when comparing to Anthem, Humana, and UHC. In the latter, the Healthplan owns and drives the PBM. In the former, CVS is purchasing Aetna, so the tides are turned opposite. Should lead to an interesting model development process.

quotes

Reply

Winston Wong, PharmD (Posted: November 02, 2017)

quotes

There is no doubt in my mind that pre-certification criteria will become more precise in identifying patients in where there therapies will be used. In the appropriate patient, payers will have a hard time denying coverage.. The trick is to find the appropriate patient. in some respects, it is no different than what we see today with other classes e.g. PCSK9's, but the stakes are higher. We can approve many PCSK9 patient for each CAR-T patient. On the other hand, we will probably see a more definite positive outcome with the CAR-T. Such a dilemma

quotes

Reply

Winston Wong, PharmD (Posted: November 02, 2017)

quotes

Educating physician about biosimilars is a big step to help gain confidence that the biosimilar will indeed produce a similar clinical benefit. But will not drive biosimilar utilization to expectations. First, we need to get the approved biosimilars out of court. The legal system is hold the biosimilars hostage. Second, with the current biosimilars only representing a 15-25% discount off the reference product, this is clearly within reach of the reference products to reduce their cost down to near parity. At a near parity cost, why switch. In short, much more than education is needed to drive biosimilar utilization, as as usual, the main factor will be the "$".

quotes

Reply

Thomas Marsland, MD (Posted: November 01, 2017)

quotes

Emergency rooms generally are not cancer patients friends. I have found that in routine community practices that if a cancer patients gets to the hospital they are almost routinely admitted. This causes frustrations for the patients and the oncologists. This is normally an after hours happening. Clearly extended office hours as proven in the "come home" project can minimize ER and hospital visits and help reduce the cost of care. Er's often over do testing and once patients are admitted especially to the hospitalist service tend to have extended admissions. Most community cancer practices can handle issues such as dehydration, N&V, diarrhea and pain control as an out patient. The concept of an observational unit is a good starting point but really most of these patients could be stabilized with minimal problems in the ER and then discharged to home with next day follow up in the office.

quotes

Reply

H. Jack West, MD (Posted: October 30, 2017)

quotes

At best, this reflects a conclusion from Merck interactions with the EMA that, unlike the US FDA, the EMA would not be persuaded by the favorable results of the phase 2 KEYNOTE-021g trial that enrolled 123 patients. The FDA decision has largely been met by surprise and some derision by many (I would even say most) specialist thoracic oncologists for being a big leap based on a phase 2 trial that, unlike an approval for therapy in a rare mutation population, is in a very common one. Moreover, the arguably premature FDA approval for carbo/pemetrexed/pembrolizumab was given despite the fact that multiple phase 3 trials of chemo vs. chemo/immunotherapy should report results in the next 6-12 months.

A skeptic might suspect that Merck's decision may be related to the company having knowledge of their phase 3 KEYNOTE-189 results not looking as favorable as the KEYNOTE-021g results. Of course, the field of oncology and especially lung cancer is replete with cases of a highly positive phase 2 trial being followed by a clearly negative phase 3 test of the same treatment (figitumumab, onartuzumab, etc.), so this is all too easy to envision.

Certainly, the fact that this was released after 4 PM ET on a Friday designates that was recognized as bad news by the company. Nobody ever waits to releases great news until moments before the weekend starts.

quotes

Reply

Thomas Marsland, MD (Posted: October 26, 2017)

quotes

OK so there are days I feel stressed... who doesn't?? But burnout not really. People have asked me when I'm going to retire and I say never... I love what I do. Dealing with oncology patients is indeed challenging. They present with complex issues... medical but also emotional, financial, psycho-social, spiritual and more. It is difficult but rewarding in helping folks get through very difficult times. The stresses and burnout problems for me are much more in dealing with the non-clinical parts of the practice. All the new recording, documenting and regulatory requirements. The EMR's have turned me into the billing, coding, and scheduling person in addition to the care provider. I have been blessed with a loving and supportive family and have always been able to leave the stress of the job at the door when I leave. Balance is important, time for oneself (and family) help me get though all the burnout issues..... a good Napa Cab helps too.....

quotes

Reply

Robert Daugherty (Posted: October 24, 2017)

quotes

It's a shame your patients are not illegal immigrants......No driver license, no social security # and most can not speak a word of English. They receive their surgeries, chemotherapy, medications, rooms and even a hospital provided interpreter and in some cases even transportation to and from the hospital. We have US citizens scraping up every dime they have saved, mortgage their homes and some cases having to sell them, pull their kids out of college, canceling their children's weddings and in some cases filing bankruptcy all struggling to pay for cancer treatments. Yet individuals that are in this country illegally get their treatments completely free, Something is wrong with this picture and needs to be stopped. We pay for this one way or the other, don't let anyone tell you illegals do not cost American taxpayer.

quotes

Reply

Winston Wong, PharmD (Posted: October 22, 2017)

quotes

It is interesting to see how situations come back around. Recall that Anthem Pharmacy Management once existed, prior to signing on with ESI. Now they are starting up the old strategy again. Whether there is more transparency or not, the one thing that will happen is that Anthem will have greater control of the over all pharmacy strategy.

quotes

Reply

Winston Wong, PharmD (Posted: October 19, 2017)

quotes

This study is very similar to the study completed by Peter Bach in 2015. Dr Bach looked at the initial cost of the drug when released, and then tracked cost increases. This study confirms his finding. No matter how you slice and dice the data, the bottom line is that we are still an a time of unsustainable cost increases. The next step is to compare the increases in the US vs. Europe.

quotes

Reply

Winston Wong, PharmD (Posted: October 19, 2017)

quotes

From the payer standpoint, there is a belief that smoking cessation programs work to some degree. At one time, it was even a requirement to participate in a program when coverage for smoking cessation products were requested to be covered. However the results were spotty. The success rate was low, driven by the overall member motivation to take the program seriously and successfully complete the program. If we focus on that small piece of the population, the ROI is significant. But looking at it from an overall standpoint, the ROI is not as impressive

quotes

Reply

Sasi (Posted: October 19, 2017)

quotes

Who can afford this drug?

quotes

Reply

Dean Gesme, MD (Posted: October 18, 2017)

quotes

Rehabilitation and Pre-habilitation are woefully underutilized by oncologists as adjuncts to the treatments which we prescribe. Patients deserve the opportunity to optimize their physical wellbeing in order to maximize quality of life and minimize treatment related toxicities.

quotes

Reply

Robert D Orzechowski (Posted: October 16, 2017)

quotes

Thanks, Don, for publicizing this despicable behavior by the upstream entities involved in the drug value chain for cancer patients.
While about 90% of all SP prescriptions are for generics, only about 10% of private oncology practice's dispensing is for generics. Compounding this situation are the delays for drugs and approvals by SPs, which compromise patient care. It is not hard to quantify the significant waste and cost avoidance the community oncology dispensary or pharmacy can capture and thus reduce the cost of care while ensuring high quality, timely, care. Employers who purchase these group health and Rx benefits are unaware of the cost impact they subsidize with the plan designs they buy for employees.

quotes

Reply

H. Jack West, MD (Posted: October 10, 2017)

quotes

This is an unfortunate result, in a hard setting to treat. About 20% of patients with advanced NSCLC have a KRAS mutation, making it the most common molecular aberration we see, but also one for which we have no effective targeted therapy. Abemaciclib demonstrated promising activity in earlier phase clinical studies, so this was certainly an important study. However, the fact that patients with a KRAS mutation are well recognized as been especially unlikely to benefit much from EGFR TKI therapy like erlotinib have led some critics to charge that the control arm in this study was receiving what we might interpret as little more than a placebo with side effects.

Nevertheless, there was no difference in overall survival. Despite the improvements in some secondary endpoints and the charge that the control arm did better than expected (which I believe was due to the requirement that patients have failed docetaxel-based chemo, along with most having received an immune checkpoint inhibitor as well, making this a highly selected population for less aggressively paced disease), these results will likely not be enough to make this a viable treatment approach.

Effective treatment for KRAS mutated NSCLC remains a significant unmet need, with insufficient progress marked by this agent and trial.

quotes

Reply

H. Jack West, MD (Posted: October 09, 2017)

quotes

The data from FLAURA definitely support a first line approval, and the NCCN has just revised their guidelines in NSCLC to reflect that. The lung cancer community looks forward to a prompt approval of osimertinib in the first line setting. I have several patients in whom I am eager to prescribe osimertinib based on this indication. It can't happen soon enough.

quotes

Reply

patrick stagg (Posted: October 08, 2017)

quotes

It was one of the reasons I was happy to retire from the hospital owned practice. Most physicians probably do not see the difference, but our lab charges went from double digits as private practitioners to triple digits. Chemotherapy I did not want to see.

quotes

Reply

Thomas Marsland, MD (Posted: October 05, 2017)

quotes

This is an interesting concept. Although this sounds good it may not in the long run hold down drug costs. If a producer knows that 20% (40,50 whatever %) of the treatments are not effective then what is to prevent them from just adding 20% to the initial cost of the drug knowing that they will have to refund that 20%? This indeed is a proposal that should be studied and indeed was discussed in the ASCO white paper on drug costs but is really needed is transparency on how drug prices are developed in the first place.

quotes

Reply

Dean Gesme, MD (Posted: October 05, 2017)

quotes

An excellent editorial this past week in JCO authored by Jim Armitage and Dan Longo on this important topic.

quotes

Reply

Trish Goldsmith (Posted: October 05, 2017)

quotes

Bill is spot on with respect to his comments and concerns related to the latest iteration of an NCCN product. Over 20 years of work and institutional effort has been devoted to the highly respected NCCN Guidelines and derivative NCCN Drugs and Biologics Compendium.
It is once again disconcerting to see yet another way in which this highly effective and influential effort has devolved. It is also, yet again, another demonstration of the total absence of the patient voice in bringing value to the the delivery and coverage of oncology care in the US.
In addition, it is totally devoid of valuable input from the industry that has and continues to provide NCCN with the vast majority of their vital funding. This funding allows NCCN to continue the good work of those that have devoted tens of thousands of hours to ensure that all patients have access to the best standard of care in oncology.
The voice of patients that count on NCCN and the industry that funds them must be acknowledged and valued.

quotes

Reply

Thomas Marsland, MD (Posted: October 04, 2017)

quotes

So clearly less is less..... but less for some maybe more for others. The hospitals have used the 340B program to expand their control of cancer care for years. In the Xcenda report discussed in prior OBR daily's it is noted that 75% of the hospital acquired practices come from those with 340B status. So much for that margin providing indigent care... That report also discusses how hospital centered care costs 60% more than the same care delivered in a private practice setting. This amounts to $90,000 a year more per patient. That report also describes a much greater ER and hospitalization rate by hospital based practice. Community physicians have been under the gun with falling reimbursement for years and that has led to improved quality and efficiency's such as the Come Home Oncology Medical home. Another interesting comment in Moody report points out that patients actually will save $180 million dollars a year. It makes no sense to continue to subsidize hospital programs that result in greater cost of care. Hospitals need to learn to reduce their costs as the doctors in private practice learned to do. The 340B program is broken and abused by hospitals to sustain their margins and inefficiency. The playing field needs to be equalized.

quotes

Reply

Thomas Marsland, MD (Posted: October 02, 2017)

quotes

I recently had the opportunity to talk with a group of medical oncologists about MACRA. Many of these physicians are still practicing in small groups or single doctor offices. At the end of the discussion I felt I had to hand out prescriptions for Zolof (a good Napa Cab had already been supplied). They were clearly overwhelmed with the rules and regulations and compliance issues in the new law. These heap additional expenses on already overburdened small practices. This report AGAIN demonstrates the cost efficiency of care delivered in the private practice setting. When physicians control the care delivery, we have continually shown that we can do a better job at cost control than care delivered in a hospital program. Hospitals have a dramatic economic advantage over private practice with things like the 340B pricing and the OPPS. They can give the oncologist greater economic security but at a larger cost for equivalent care. The powers that be must soon understand that the present system is driving doctor out of private practice and that if effort to equalize the reimbursement landscape are not changed there will be no private practices left (I suspect that is their real objective).

quotes

Reply

Dean Gesme, MD (Posted: October 02, 2017)

quotes

Early results affirm that this new agent might offer additive benefits in the evolution of serial therapies for castrate resistant prostate cancer.

quotes

Reply

H. Jack West, MD (Posted: October 02, 2017)

quotes

Sadly the headline, "DNA Mutations Shed in Blood Predicts Response to Immunotherapy in Patients with Cancer" leaves out the phrase "with no better accuracy than standard PD-L1 testing". To be clear, if positive, patients have a 45% response, and if negative, it's 15%.

Perhaps a better headline would be "New test NOT helpful, with results neither necessary nor sufficient to predict which patients will benefit from immunotherapy".

quotes

Reply

Howard S. Hochster, MD (Posted: October 02, 2017)

quotes

This interesting study from Kurzrock and colleagues looks at circulating tumor DNA (ctDNA) to determine who may benefit from immunotherapy. The study included 69 patients with various diagnoses. With more than 3 mutations detected on the 70-gene panel the response rate was 45% in this group compared with 15% for those with 3 or fewer mutations. Presumably this is closely linked with the calculated "tumor mutation burdern" score. This is a good step in the effort to define the utility of ctDNA which is determined on a blood draw and can be done serially. The title refers to this as "liquid biopsy" though in the old days it was just "phlebotomy" for a blood analysis.

quotes

Reply

Jeff Patton (Posted: September 28, 2017)

quotes

We have know for years that the community setting is the lower cost site of care but have been slow perform and publish the studies to prove our case. Congratulations to Dr. Gordan and his collaborators for this publications. Hopefully as we move toward value based reimbursements patient treatment will migrate back to community oncology clinics where the cost of care is lower and patient convenience is better.

quotes

Reply

Dean Gesme, MD (Posted: September 26, 2017)

quotes

Lower radiation doses in HPV+ Head & Neck cancer would dramatically reduce toxicity and expense of treating this rapidly increasing virally related malignancy. Potentially practice changing with additional confirmatory data.

quotes

Reply

H. Jack West, MD (Posted: September 25, 2017)

quotes

I thought this result might actually have clinical implications until I saw that the randomized trial enrolled 29 patients. It's ridiculous to draw any conclusions from a randomized trial of so few patients. it's interesting and provocative, but it needs adequate follow-up in the form of an appropriately sized phase II trial, or better yet, phase III results.

quotes

Reply

Trish Goldsmith (Posted: September 22, 2017)

quotes

Bill is spot on. It is truly sad to see such a wonderful and influential product and the outcome of many years of hard work devolve into its latest iteration. Yet again, another example of a product that is totally devoid of patient input.

quotes

Reply

Robin Hutchinson (Posted: September 19, 2017)

quotes

I have to salute FCS for always going above and beyond to care for their patients. There are 47 FCS locations in my territory and Dr. Bustinza is one of the physicians I call on. Dr. Bustinza is such an outstanding physician that it does not surprise me that he and the practice made sure this special gentleman (patient) received the care he needed.

quotes

Reply

Howard S. Hochster, MD (Posted: September 15, 2017)

quotes

First approval for a biosimilar in solid tumor usage! This should help bring down the cost of bev by about 1/3. Other bev biosimilars to follow. There is no approval for interchangeability with originator bev, and this must be prescribed specifically using the suffix. But this should be regarded as a step forward for patients and for control of costs. Ironically, Amgen took Novartis to the SCOTUS to delay their roll out of biosimilar filgrastim. Speak to your pharmacy committees!

quotes

Reply

H. Jack West, MD (Posted: September 08, 2017)

quotes

The results of the ALUR trial are impressive but not surprising at all. We should expect a second generation ALK inhibitor to be superior to chemotherapy in crizotinib-pretreated ALK-positive patients. The difference is very striking and highly clinically significant in every efficacy endpoint. The efficacy of chemotherapy was rather disappointing overall. But this trial population should not exist for much longer.

Today, with alectinib now becoming the first line therapy of choice for ALK-positive questions, the more relevant question is whether a subsequent alternative second generation ALK inhibitor, such as brigatinib, is a better choice than chemotherapy in alectinib-pretreated patients.

quotes

Reply

Thomas Marsland, MD (Posted: September 05, 2017)

quotes

WOW...that is a hunk of change...BUT it would appear that Novartis is at least following some of the suggestions in the recent ASCO paper on drug prices. They would appear to be looking at whether the drug works or not as part of the pricing. In addition they are also considering different pricing for different diseases with different efficacy and hence a somewhat different value proposition. Both approaches suggested in the ASCO report. With that said, $475,000 is still a heck of a lot of money. There is still very much a lack of transparency in how they came up with that number. It is interesting the market was predicting even higher pricing so this number makes them look good. They quote a billion dollars in investment but that is the number quoted for any new drug so why the huge pricing difference for this drug compared to other new innovative cancer therapies. Clearly Novartis has taken some steps toward better drug pricing but no question we still need to do better at controlling new drug costs (some old ones too...)

quotes

Reply

Howard (Jack) West, MD (Posted: August 30, 2017)

quotes

FLAURA was added to the meeting and press program after I wrote these comments. We will still need to see whether the PFS benefit is of a magnitude that is worthy of a change in practice, but it's reassuring that the data will be presented at this first large meeting after the press release.

quotes

Reply

Thomas Marsland, MD (Posted: August 17, 2017)

quotes

So I actually had the chance to read this article in the Sunday Times while traveling (am usually more of a WSJ guy). I think it raises a number of interesting points. One is the idea of how many drugs in a given category do we really need? Are 20 check point inhibitors really necessary? Yet every company wants to have one of their own. I would respectfully suggest that after the first two or three drugs in a given category, if efficacy is comparable, that cost as part of the value proposition should be considered in the approval process. If it costs less then it should be approved. Clearly one of the issues is that we need to put more patients on trials. In adult community oncology we put as an average only about 5% of patients on trials. We should undertake a national initiative to increase this number significantly. Why not 15% or more??? As the cost of treatments escalates it is even more important that we have the right drug for the right patient at the right time. Only through research and clinical trials will we be able to do that. With that being said we therefore need to make trials more available and easier to use in the community. Trial design looking at alternate marker outcomes for target treatments will result in shorter, less costly trials requiring fewer patients. As I said in one of my other comments, having clinical trials available in my new practice has gone a long way toward making it more fun again.

quotes

Reply

H. Jack West, MD (Posted: August 14, 2017)

quotes

It appears that while the PACIFIC trial of durvalumab consolidation after chemoradiation is being presented at ESMO, we won't see data from either the MYSTIC trial (durvalumab/tremelimumab or durvalumab monotherapy vs. chemo doublet first line for advanced NSCLC) or FLAURA (first line osimertinib vs. erlotinib or gefitinib for EGFR mutation-positive advanced NSCLC).

We knew MYSTIC is negative for a PFS benefit, so we should perhaps not be surprised that AZ isn't eager to highlight the results, but I think if there were anything favorable to mitigate the disappointment, they'd have tried to stanch the bleeding by presenting the data. I suspect there will be little to encourage us when AZ ultimately deigns to show us real data.

More notable is the omission of FLAURA from the ESMO program, a trial reported as positive for a significant improvement in the primary endpoint of PFS that could potentially change practice and broaden the indication for osimertinib to include first line treatment if the PFS benefit is substantial enough. Unless AZ just doesn't want to compete for the limelight with the PACIFIC trial that will likely cause a Beatlemania-reminiscent hysteria by both being an immunotherapy and being positive, this suggests that the results aren't as captivating as some would have hoped. As an alternative, the IASLC may have promised the moon and the stars to AZ to postpone presentation of a high-impact trial for the first time at the World Conference on Lung Cancer, but I would have anticipated that AZ should want to get positive results out on a potentially practice-changing therapy to as broad an audience as possible, as quickly as possible.

We'll eventually see what the data show, but I'm disappointed that two of three important lung cancer trials from which we've heard initial results from recent press releases apparently won't be presented at ESMO.

Makes you wonder why they're dragging their feet.

quotes

Reply

Winston Wong, PharmD (Posted: August 14, 2017)

quotes

The rationale is pretty simple. The branded drugs are now presenting deep rebate discounts, and bring the net cost to somewhere comparable to the generic/biosimilar. If the cheaper drug was dispensed outright, the only win is the patient paying the lower copay and payer experiences an immediate cost savings. If the more expensive brand is dispensed, the PBM/Payer get the rebate, of which the PBM receives a portion of, and hopefully the piece of the rebate that is passed through to the payer will bring the cost down, if they can even track it. So in essence, that final statement is very true. Someone has to be making money from the deal to make it fly.

quotes

Reply

Thomas Marsland, MD (Posted: August 10, 2017)

quotes

So I usually do not even know the exact cost of the drugs. I believe for me and many of us this is a carry over from the days that chemo was a revenue generator for the practice and I did not want to be biased by potential income and wanted to base my treatment recommendations based on the effectiveness and toxicity of the drugs. With that said I am aware of the general expense of the drugs and will often tell patients that the treatment is "expensive." Indeed we do make treatment choice today based on cost, especially in relation to whether the treatment may fall under the medical or pharmacy benefit package. We do have financial counsilors in our practice who can and do have the expertise to make patients aware of the cost of therapies. It really is unrealistic to expect the doc to spend a lot to time talking about drug cost and insurance benefits, things about which we really know every little when our time is much better spent discussing the patient's disease, treatments, and outcomes. The recent NCCN review of patient concept of value confirms that what they really want is time with the physician to discuss their outcomes. Clearly cost is a key piece of the value proposition but it is not the only one and I believe patients are better served discussion cost and coverage with our financial councilors who are better trained to do this than me.

quotes

Reply

Thomas Marsland, MD (Posted: August 08, 2017)

quotes

I would tend to agree that the oncologist generally should be the one to deliver long term follow up care. There really are several reasons for this. The patient and the oncologist develop a generally intense relationship during the times of active disease and treatments. The level of trust and communication is often more than that experienced in other settings. Also we in the oncology field tend to be more available to our active patients who many times need to be seen acutely and cannot wait for delayed appointments. These carry over as patients transition into survivorship care. There is just that level of comfort for all parties. In addition it always made my day to see Ms Jones my 20 year breast cancer survivor; it is important for us as the care givers to experience the success stories too. All this is not to say others cannot provide this longer term care but at least for me I would definitely be missing something.....

quotes

Reply

Thomas Marsland, MD (Posted: August 08, 2017)

quotes

Thank you Reagan-Udall foundation. One of the really great things to come from my recent move to California (aside from all the great wines...) is the very active research program my new practice has. In all the different Jax practices we had very limited research opportunities. In Petaluma/Santa Rosa the research environment is robust. This group puts 15% of patients on clinical trials much better than the average. It has helped me in my patient management to have access to the newest and best protocols. The R-U Foundation adds another piece to this. I think that we all need to rededicate ourselves to clinical trials and research. It is the only way we will develop the "right drug, right patient, and right time" that will be critical to delivering the quality and value going forward.

quotes

Reply

Dean Gesme, MD (Posted: August 07, 2017)

quotes

After a decade with only sorafenib for advanced HCC, it is refreshing to have several promising new targeted drugs and immunotherapies vying for first and second line status in this disease.

quotes

Reply

Winston Wong, PharmD (Posted: August 04, 2017)

quotes

The finger pointing between Pharma and the PBM's is looking much like the political arena with regards to ACA. In all reality, both are stockholders and both contribute to the high cost of drugs. The last factor that no one is considering is that whatever, and wherever the price is set at, we will reimburse. That is not the case in Europe, especially in the countries mentioned. In those countries, if the price is too high, the drug is not reimbursed.

quotes

Reply

Winston Wong, PharmD (Posted: August 04, 2017)

quotes

The initial release discount of 15% by Pfizer did not spark much uptake, mainly because, in my opinion, a 15% by J&J was well within striking range. Now with a 35% discount on the table, the sandbox should become more stirred up. Not that 35% is not within J&J's range as well, but the payers need to step up to the plate and drive utilization.

quotes

Reply

Winston Wong, PharmD (Posted: August 04, 2017)

quotes

Very significant findings, especially if we are looking for "Real-World" evidence. As noted, the need is not only in cancer, but in all diseases. While it is noted that physicians need to do a better job for recruitment, I would surmise that the senior population will usually have not co-morbid conditions that exclude them from the trials, as wells the senior population not being able to handle the rigid controlled monitoring process.

quotes

Reply

H. Jack West, MD (Posted: July 31, 2017)

quotes

We have learned from a press release that the PACIFIC trial is positive for a significant improvement in PFS after chemo/radiation for patients with locally advanced, unresectable NSCLC. Because this treatment entails an extra year of IV treatment every two weeks and a cost likely in the range of $180-200K per patient, most experts feel that the PFS benefit should be remarkably long and/or be accompanied by a significant improvement in survival. In this setting, demonstrating a 3-4 month delay in relapse without a survival benefit won't offset the cost in terms of time on treatment for patients or cost to society. The entire lung cancer community looks forward to the presentation of the actual trial data at an upcoming meeting -- I hope at ESMO 2017 (where I will be happy to provide commentary on the detailed findings).

If the PACIFIC trial achieves these criteria, it should rightfully become adopted as a new standard of care in this setting. It would be ideal, however, if we can determine which patients are most or least likely to benefit from this extended treatment so that we can concentrate these extra efforts and costs on the patients who will truly benefit from them.

quotes

Reply

H. Jack West, MD (Posted: July 28, 2017)

quotes

It's important to note that while the statistics may well be over-interpreted/misinterpreted to imply that pemetrexed demonstrates meaningfully superior efficacy vs. other partner agents for a platinum in advanced non-squamous NSCLC, I and most of my colleagues who have a particular focus and expertise in thoracic oncologists try to be very judicious in our interpretation of the landscape. Few if any of us would consider pemetrexed to be the clear best choice among the various options, and I don't think any expert would consider alternatives to be a wrong choice. That said, there is near uniformity in favoring carbo/pemetrexed +/- bevacizumab in advanced non-squamous NSCLC not because it's overwhelmingly better but because it's just better enough in its therapeutic index to bubble up to the top. We need to choose one regimen, and for nearly all thoracic oncologists who have a full range of options available, the combination of good if not markedly superior efficacy combined with the favorable side effect profile, convenient schedule, and several other factors make it the best option to nearly all of us, even if not by a wide margin.

That it is expensive, and specifically more expensive than some very inexpensive and perfectly serviceable alternatives is a separate question. The reality of the situation is that few specialists in thoracic oncology are forced to weigh or even carefully consider the question of the incremental value of pemetrexed over other alternatives. Unless that issue becomes prioritized enough for US oncologists to be incentivized to carefully consider the relative costs of agents, we will focus far more on the patient experience and patient/physician satisfaction without feeling compelled to seek a relative bargain option.

quotes

Reply

H. Jack West, MD (Posted: July 27, 2017)

quotes

This is an important trial and a potential totally practice-changing result, but its true significance will ultimately depend on whether the PFS difference is not just statistically significantly better but whether the PFS with first line osimertinib is at least 6-7 months, and ideally more like 9-10 months better than gefitinib or erlotinib. Because first line osimertinib means losing a line of therapy for about 50-60% of patients who would test positive for T790M after first line gefitinib or erlotinib and still receive osimertinib second line (with an expected PFS of about 9 months), a PFS benefit of 5.5 months could be statistically significant for PFS benefit but not truly better than sequential therapies.

We will anxiously await the data from the trial, presumably to be presented at ESMO in September. I think the difference could turn out to be more than enough (thinking of the results of the ALEX trial in ALK positive NSCLC as an example), or it may turn out to be statistically superior at an endpoint that still isn't enough. I'll be looking for at least 7 months of PFS benefit (I'd discount from the 9-10 month PFS expected from second line osimertinib because here 100% of patients will receive the benefit, rather than just 50-60%), or an improvement in overall survival when we see the actual data.

quotes

Reply

H. Jack West, MD (Posted: July 27, 2017)

quotes

This is a very important negative result, as far too many thoracic oncology experts and financial analysts had already declared immunotherapy combinations as the second coming of the Salk vaccine and the presumed new standard for lung cancer for the future. As I and many other sober-minded people tried to remind everyone, we needed to SEE ACTUAL phase III data before drawing conclusions. As it turns out, this immunotherapy combination of durvalumab/tremelimumab at least, has failed to show a PFS benefit.

While it's remotely possible the IO combination will prove to be significantly better, we heard nothing positive about MYSTIC in this report, so I suspect that there is nothing encouraging to say about it. We haven't yet heard anything about the Checkmate-227 trial of nivolumab/ipilimumab, these agents are similar enough that I think it's very unlikely that another PD-1/CTLA-4 inhibitor will lead to a substantially different result. Moreover, this combination will need to be so much better that it justifies the phenomenally increased cost of the combination, as well as the likely far more challenging toxicity profile.

A sobering dose of reality, but one needed to remind us of the value of not getting too far ahead of the data in our speculation.

quotes

Reply

Jeff Patton (Posted: July 19, 2017)

quotes

It certainly appears the hospital lobby is getting their money's worth on the democratic side of the isle, and as per usual inconvenient facts are being ignored or distorted. For anyone that understands anything about business to say that huge government imposed discounts won't be offset with price increases is nonsense. Almost everyone agrees with the original intent of the 340B program but the explosion of the program is out of control. Cruise by your local tax exempt hospital and you will likely see cranes not hospital wing closures.

quotes

Reply

john (Posted: June 29, 2017)

quotes

Thank you for catching that error. We have corrected the sentence.

quotes

Reply

cate (Posted: June 28, 2017)

quotes

I believe that there is an error in the text. Monarch 2 is in hormone-receptor-positive, HER2-negative breast cancer. The first paragraph in that section says that it is HER2-positive.

quotes

Reply

Thomas Marsland, MD (Posted: June 28, 2017)

quotes

What a good looking group. Think I actually recognize a couple of them..... Indeed it was a good meeting. ASCO really is making itself visible at the AMA. We are truly proud of our own Barbara McAneny who was elected president of the AMA. She is a strong voice for community practices. ASCO heads the Cancer Caucus and helps spearhead resolutions that effect cancer care. But more and more it is clear that "our" issues really are issues that impact all of medicine. One can see from the article that MOC, MACRA, opiod abuse and network adequacy are issue effecting not only us but all. What really struct me was the true diversity of our AMA. The House of Delegates has its share of us old white dudes but the mix really is broad based. Doctors of all genders, race, sexual preference, age and political persuasion are represented. Resolutions are hotly debated since clearly such a diverse group has many opinions. The debates are always polite, respectful and comprehensive. The speakers of the house do a great job "herding cats." In the end resolutions are accepted by vote with majority rules. The main driving motivation of all of us there really is we all want the best patient care. Our national leaders could take a good lesson from the AMA House. I would encourage folks to consider joining the AMA. It really does do a good job of addressing issue critical to all of us....

quotes

Reply

H. Jack West, MD (Posted: June 23, 2017)

quotes

The approval of the dabrafenib/trametinib combination is significant for potentially tipping the scale clearly in favor of broader genomic NGS testing of lung cancer rather than a more selective approach of individual markers only. With BRAF V600E, a mutation seen in 1-3% of NSCLC, as the 4th clearly actionable marker for which we have an approved targeted therapy, the list of markers for which there is an effective therapy becomes long enough to move a growing population of oncologists off of the fence about NGS testing. This is especially true with effective therapy for MET exon 14 mutations and potentially also RET, HER2, and others looming as additional targets with sufficient treatment options to justify looking for them routinely.

Though patients with BRAF V600E are uncommon, the response rate with this combination is over 60%, and the median progression-free survival is in a range that clearly exceeds that of chemotherapy and should lead us to favor this approach; notably the approval doesn't specify a line of therapy in which this regimen should be pursued. The toxicity of the doublet is a relevant favor, I think particularly with regard to pyrexia. The cost of treatment, with a pair of expensive targeted therapies, is another challenge that could keep it from being eagerly adopted. There is certainly some risk of BRAF V600E becoming a "don't ask, don't tell" marker that isn't invariably looked for by oncologists unless there is a clear expectation/mandate/incentive to do so.

I think that this could be more significant for its implications in broadening the appeal of NGS for lung cancer than any major enthusiasm for dabrafenib/trametinib in BRAF V600E. It could tip the scale toward broad sequencing and at least provide a compelling option to answer the question of what to do if you find this marker.

quotes

Reply

Winston Wong, PharmD (Posted: June 20, 2017)

quotes

The article points out the biggest concern associated with the so-called abuse of the 340B program. As noted, the 340B program was intended to provide care to the poor. As such, while the institution requires a 51% discount on medications, the institution can bill the patient's insurer for the normal negotiated amount, thus allowing the institution to use the margin to help subsidize the care provided. Technically, the institution is suppose to bill for medications used for the poor only, but that has expanded to a larger population as noted. This is a pretty accurate description of the abuse that is taking place, which is contributing to the high cost of drugs. There has been talk of tightening the system up for years, but it has yet to happen.

quotes

Reply

Thomas Marsland, MD (Posted: June 20, 2017)

quotes

I had the opportunity to sit in on a presentation on OCM at the recent annual meeting in Chicago. It was clear from all the presentations that to transition from the traditional volume based compensation model to one based on value and clinical outcome that a robust IT platform is critical. We need to collect, review, and react on multiple data points in determining quality outcome and cost. The Flatiron program looks to fulfill those requirements. It does not surprise me to see Jeff and Bill leading the way... I would expect nothing less...

quotes

Reply

Winston Wong, PharmD (Posted: June 16, 2017)

quotes

There is an infrastructure problem, and the problem is that we need to do a better job to show the trust value of the generic profiling so that it will be paid for. If the tests are covered, the drugs will be used. Next, we need to have more comparative trials between like drug in classes so we definitely will know if one drug is better over another. Finally, we need to rebuild the entire reimbursement system so that pricing is not driven by what the market will accept. Simple changes .... Let's get them done!!

quotes

Reply

Winston Wong, PharmD (Posted: June 16, 2017)

quotes

This sounds like the same play innovator manufacturers are playing in the biosimilar world, where the reference product is not being made available to biosimilar companies to conduct their comparative studies. One other point to be made here is was the increase in copay from $42 to $250 due to the price increase solely, or due to a change in the benefit design?

quotes

Reply

Thomas Marsland, MD (Posted: June 16, 2017)

quotes

So one of the significant changes in all of the newer compensation models based on value is to include the idea of the what is important to the patient. We have to some extent done that but unfortunately all to often in the more traditional fee for service the patients perspective of what is valuable was not address. Value will change from patient to patient. What is important to a 35 year old mother will be drastically different than what if valuable to an 80 year old gentleman. Another important point is that these discussions have to be ongoing since the patients' definition of value will change as they migrate through the cancer treatment world. Formalizing the patients views as part of the ongoing record is a needed step forward.

quotes

Reply

Thomas Marsland, MD (Posted: June 16, 2017)

quotes

So right patient, right drug, right time. But it is not really that easy. As the author suggest more research is needed but in these tumors with rare targetable mutations collecting enough data is difficult. The prospective randomize trial will always be the gold standard but for rare tumors we may well have to rely on pooled real world data. Agree that the infrastructure is not yet in place but a number of programs such as ASCO's Cancer LinQ are being developed. It is critical that all of us participate in this and like programs to assure that we can accumulate sufficient data to help decide who is the right patient; which is the right drug; and when is the right time.

quotes

Reply

Jeff Patton (Posted: June 16, 2017)

quotes

Once again COA gets it right. MedPAC is completely out of touch with both the clinical issues and market forces in medicine. We all need to aggressively support COA to represent the interests of us and our patients.

quotes

Reply

Winston Wong, PharmD (Posted: June 15, 2017)

quotes

This is a big win for biosimilars. While biosimilars may not be discounted as much as expected, we are still seeing cost savings as rebates arrangements are becoming more aggressive. So now the question is whether the biosimilar manufacturers are ready to begin production sooner.

quotes

Reply

Jeff Patton, M.D. (Posted: June 14, 2017)

quotes

This is great news for community oncology. Barbara will be a great champion for us and the value we bring to our patients and our community. Congratulations Barbara!

quotes

Reply

Howard S. Hochster, MD (Posted: June 13, 2017)

quotes

A victory for consumers and cost control. SCOTUS overcame lower court considerations and parsed the BPCIA wording to mean that the biosimilar manufacturer does not need to wait 180 days after FDA approval. They can notify the originator company before actual approval. This cuts out the extra 6 month exclusivity Amgen was seeking. Looking forward to
more biosimilar molecules on the market next year.

quotes

Reply

john (Posted: June 12, 2017)

quotes

Editor's Note: We are in agreement with your comment and have removed the word "severe" from the sentence.

quotes

Reply

Winston Wong, PharmD (Posted: June 12, 2017)

quotes

Very positive for the genomic profiling movement. It goes along with the approval of Keytruda for cancers based upon a genomic result. This will be a challenge for for payers.

quotes

Reply

Winston Wong, PharmD (Posted: June 12, 2017)

quotes

The last time I looked up banning DTC ads, the US was only one of two countries that actually allowed advertisement on medications. We have plenty of other things that are banned, so why not DTC ads. think of the billions of dollars that goes into DTC ad, which could either be put back into the system, or used to low prices.

quotes

Reply

donsharpe (Posted: June 12, 2017)

quotes

This article contains a severe mistake in the first paragraph. The authors have confused the incidence of all grade adverse events with that of serious adverse events and misstate the following”…as 80% of the Nexavar-recipient patients in the SHARP trial experienced serious adverse events including diarrhea, hand-foot skin reaction and others.” The correct numbers can be found in the NEJM publication (cited as reference #2). Please kindly correct that statement by removing the word “serious” from the sentence.

quotes

Reply

H. Jack West, MD (Posted: June 09, 2017)

quotes

CIMA-vax-EGF is the most hype-driven piffle in lung cancer since dichloroacetate. There is staggeringly little evidence to justify the mania around it. It merits study, but it doesn't merit feature stories based on the very marginal data thus far. Everything written about it in the mainstream media is driven by ignorance. True experts in lung cancer roll their eyes over such gullibility and the promotion of so much false hope.

quotes

Reply

Dean Gesme, MD (Posted: June 09, 2017)

quotes

Patient Financial Counselors (PFCs) are vital to patient quality of life - they reassure and support our patients every day so that we can minimize financial toxicity from our interventions.

quotes

Reply

Ted Okon (Posted: June 09, 2017)

quotes

This seems to be band-aiding the drug price issue, which near the root are the increasing discounts (340B) and rebates (PBMs) that are fueling increasing drug prices. So, where does this approach lead and end? Constantly cutting drug dosages to find the bare minimum needed?

quotes

Reply

Howard S. Hochster, MD (Posted: June 09, 2017)

quotes

Another article by Gina Kolata where she dramatizes the situation and misses the key message. This article focuses on the fact that anti-PD1 did not work for most CRC (specifically citing the "failed" drug nivolumab) and how pembro turned it around for MSI-high patients. She brings up the cost and this has become the focus of many tweets on the article.

She misses the most newsworthy fact that this is a groundbreaking approval for the FDA, moving from a histologic indication to a molecular indication. As practicing oncologists, we must stand and applaud the FDA for stepping outside their comfort zone on this one and recognizing the realities of treating such patients.

MSI status now becomes a therapeutic handle rather than a genetic disease-related effect.

Gina Kolata did, however, do a fine job recognizing the key contribution of Dr Luis Diaz here.

quotes

Reply

admin (Posted: June 08, 2017)

quotes

Test

quotes

Reply

Thomas Marsland, MD (Posted: June 08, 2017)

quotes

This release and the recent FDA activity show that the brave new world has arrived. We are now looking at and treating tumors based on biology as opposed to the old system based on anatomy. Clearly that is not going away anytime soon but at least the approach of treating a tumor based on its biology has finally arrived.

quotes

Reply

Winston Wong, PharmD (Posted: June 08, 2017)

quotes

While outcomes based contracting resented to the issue of recovering wasted cost for ineffective therapies, does it really address the high cost to begin with, and addressing the value of the therapy. So the regimen helps the patient achieve therapeutic endpoints, but that does not necessarily translate to a cost effective treatment option. A high cost is still a high cost, even if you hit your endpoints.

quotes

Reply

Winston Wong, PharmD (Posted: June 08, 2017)

quotes

Drug importation, let Medicare negotiate rebates, PBM transparency? How long have we heard these options being bounced around. Justifying price increases is a new one, but who is going to determine what is justified and what is not. Then you have all the lobbying that goes on behind closed doors. Will anything ever be put onto the table.?

quotes

Reply

Winston Wong, PharmD (Posted: June 08, 2017)

quotes

Fully agree that the data must drive the treatment decision, however, given the growing European experience, should that be taken into account as well? For the time being, we are only looking at "similar" products today, and authorization is still required to exchange a reference product with a biosiilar.

quotes

Reply

Winston Wong, PharmD (Posted: June 08, 2017)

quotes

This bold move by the FDA will pose major issues for payers, as payers are site and indication driven. Payers have a hard enough time seeing the clinical utility of any genomic profiling signature, let alone have a drug be based upon. The payers are going to flex in their approach to genomic testing if further approvals like take place, especially given the cost of Keytruda.

quotes

Reply

H. Jack West, MD (Posted: June 07, 2017)

quotes

These data with immunotherapy are not definitive, but they certainly represent a promising option and previously treated patients who really have no compelling alternative with any good hint of meaningful benefit. I have one patient with previously treated mesothelioma who have received some benefit from an immune checkpoint inhibitor after she demonstrated progression on prior platinum and pemetrexed chemotherapy, and while she has not demonstrated what would be considered an objective response (mesothelioma is notoriously difficult to assess well on imaging), she has demonstrated ongoing and very prolonged period of stable disease to minor disease shrinkage accompanied by an improvement in her cancer-related symptoms. I certainly do not doubt that she is receiving a very clinically significant benefit from immunotherapy, despite the lack of an objective response. I would not want to put too find a point on the limited data we have available thus far, and especially my single patient experience (I have given an immune checkpoint inhibitor to another 2-3 patients who have not done as well), but I do think that we can and should be encouraged by even limited data showing meaningful clinical activity in a setting in which we have had nothing constructive to offer up to this point.

quotes

Reply

H. Jack West, MD (Posted: June 07, 2017)

quotes

The results from the phase 3 AURA3 trial that directly compares osimertinib to chemotherapy in EGFR mutation-positive patients with acquired resistance to an earlier EGFR inhibitorVery clearly demonstrate a significant improvement in disease control with in the CNS with osimertinib. In addition to leading to good disease control in patients with brain metastases, there was even documented activity in a small subset of patients who have leptomeningeal carcinomatosis.

This is emerging as a very significant consideration as we follow and treat these patients longitudinally, as they have a high risk of CNS involvement.Many of us would welcome the opportunity to have EGFR mutation-positive patients receive osimertinib to treat or prevent CNS disease as soon as we could feasibly have him start on it, including ideally in patients who may not have a T790M mutation. Osimertinib emerge as an appropriate first line treatment option for EGFR mutation-positive patients based on the results of the FLAURA trial comparing it to first line gefitinib or erlotinib -- we expect to learn the results from that study as early as this fall.

quotes

Reply

Howard S. Hochster, MD (Posted: June 05, 2017)

quotes

It's not the reporting but early intervention by caregivers to deal with symptoms of chemotherapy treatment. An amazing result! This results in fewer hospitalizations and improved survival. We need to up our game and proactively manage symptoms whether by PRO tools or direct contact. Everyone benefits.

quotes

Reply

Howard S. Hochster, MD (Posted: June 05, 2017)

quotes

The combined analysis of more than 12000 patients in 6 randomize trial was intended to show a noninferiority of 3 months FOLFOX or CapeOX with 95% confidence. As it turned out the HR = 1.07 with 95%CI = 1.0 to 1.15 for the primary endpoint of 3 yr DFS (or 0.9% absolute difference). This means the we have 95% confidence that the shorter course may be equal as much as 1.8% worse at the most. It seems reasonable to assume these are as equal as possible to define. Also, across subsets of good risk (T3 or N1) 3 months was non-inferior. And CapeOX was more effective and non inferior across the board, though this was not a randomized assignment (physician choice in most studies). We can be comfortable that 3 months of CapeOX (and probably FOLFOX) is as good as 6 months treatment for good risk patients receiving adjuvant therapy.

quotes

Reply

Howard S. Hochster, MD (Posted: June 01, 2017)

quotes

It's a big day in drug development as the FDA accepts the concept of a drug use matching the molecular biology and not histologic type. This will benefit the rare patients with Lynch and spontaneous MSI status in endometrial, urothelial, gastric, cholangio and pancreatic cancers. The big questions now are who and when to test. IHC or NGS panel? Early in diagnosis or late? Stay tuned. Perhaps we wil see more broad approvals based on molecular phenotype. But caution is warranted - the BRAF story has played out differently in melanoma and colon cancer.
Test.
Gastric

quotes

Reply

Howard S. Hochster, MD (Posted: June 01, 2017)

quotes

Readers beware!! This is a "thought" experiment where a committee of hepatic surgeons decided on resectability of the hepatic metastases based on CT scans from the SIRTEX colon studies. It doesn't mean all the patients would be resectable (many may have occult extra-hepatic disease at time of surgery) and eligibility did NOT require liver only disease. Until actual resection data and survival statistics are presented, this should be regarded as an "in cerebro" experiment only.

quotes

Reply

Howard S. Hochster, MD (Posted: June 01, 2017)

quotes

Cost Effecriveness is the charge of NICE. We know about the effectiveness. At what cost has Merck agreed to provide the drug to NHS patients?

quotes

Reply

isac i schnirer (Posted: May 26, 2017)

quotes

it's not more resistance to treatment ,but the anti her2 drugs probably don't penetrate well the bbb,including the small molecule .

quotes

Reply

H. Jack West, MD (Posted: May 18, 2017)

quotes

In the feeding frenzy that is the business world's hype-driven interpretation of immunotherapy data, the point that the response rate in phase II trials is typically significantly higher than the better established phase III trial data is conveniently overlooked. Could IDO combinations represent a significant improvement? Sure. But docetaxel had a 25% response rate in progressing phase II trials, and carbo/taxol had a 50% response rate as first line treatment in early phase II work, and we all marvel at those crazy numbers when we learn the more sobering reality from far larger clinical trials and greater experience.

This kind of breathless over-reaction to early studies is like a Darwin award of investment. Good luck, guys. Just remember that I told you not to jump off the cliff together, like a sea of lemmings. It's the same reflexive rather than conscious thought-driven process.

quotes

Reply

Dean Gesme, MD (Posted: May 17, 2017)

quotes

Watch closely as Amazon may seek to break traditional distribution models in the drug prescibing space!

quotes

Reply

Howard S. Hochster, MD (Posted: May 15, 2017)

quotes

Dr Bob Comis was a stolid and long-term leader of the old cooperative group system. He helped lead the transformation to the new NCTN. We will miss his guidance and wisdom. A real loss for our community.

quotes

Reply

H. Jack West, MD (Posted: May 12, 2017)

quotes

Though it will be far more important to see this difference translate to a significant improvement in overall survival, this early result based on an interim report is very encouraging and has great potential to finally improve on our longstanding standard of concurrent chemo/radiation in patients with locally advanced NSCLC. Along with needing to clarify whether there is an overall survival advantage, we will need to clarify whether the benefits of durvalumab are seen comparably in patients with squamous and non-squamous NSCLC and across different levels of PD-L1 expression. These results will be among the most anticipated in lung cancer over the next several months.

quotes

Reply

sandra (Posted: May 11, 2017)

quotes

Interesting

quotes

Reply

H. Jack West, MD (Posted: May 10, 2017)

quotes

This is a weak approval based on disappointingly scant evidence, especially considering that 37 of 123 patients (30%) enrolled had 50% or greater PD-L1 expression and would now be considered as having pembrolizumab monotherapy as standard of care. With the phase III KEYNOTE-189 with the same trial design but larger, and already completed (as well as many other trials of chemo +/- checkpoint inhibitor therapy), it is disappointing that we saw such a rush to judgment. It should be viewed as putting marketing ahead of true evidence. Perhaps the more mature overall survival data (not highlighted in the press release) are more compelling now than at the time of the initial presentation and publication in October, 2016. Unfortunately, I'm afraid we will soon see that the FDA functions merely to rubber stamp marketing efforts with the slightest pretense of evidence to support commercial interests, rather than to offer a critical review of the true value of unfathomably expensive treatments that provide technically positive results on watered down endpoints.

quotes

Reply

Thomas Marsland, MD (Posted: May 10, 2017)

quotes

I have been and on again and off again reader of the Economist for a long time. This article reminded me of the quaint old English expression used by my immigrated English relatives who referred to something too expensive as "dear." The point however is on target. The ever rising cost of cancer drugs is unsustainable. The idea of "value based purchasing" is intriguing. But who and how does one decide "how well they work?" Are we looking at clinical outcomes such as response rate, over all survival, or progression free survival ? Where does the patients point of view come into the equasion ? Should we be looking at the cost for total care not just the cost of the drug? (YES) Do they mean basing cost on the efficacy in a specific clnical senario ? Clearly these are complex and valid issues. To make these choice we obviously need lots of data, including clinical outcomes, patient satisfaction, and claims information. Who and how will these data be collected ?? Hopefully some of the next generation of research tools such as Cancer Linq, Flatiron and other will help us decide the right drug, for the right patient, at the right time.

quotes

Reply

H. Jack West, MD (Posted: May 10, 2017)

quotes

The clearest point of this manuscript was that this trial showed no hint of the provocative benefit seen with the combination of docetaxel and the MEK inhibitor selumetinib in a prior phase II trial. We can debate potential explanations, and the authors and editorialists offer several hand-waving possibilities, but the only thing we definitely know is that this is yet one more stark example of a very promising phase II trial followed by a stone cold negative phase III trial, as we've seen with figitumumab, onartuzumab, ASA-404, talactoferrin, and a long list of other agents/trials.

I don't know how many times we'll need to see this pattern before we control our hubris in calling a definitive win based on encouraging phase II data. With modest numbers of patients from a very limited number of treating centers, phase II trials are clearly a poor substitute for the broader clinical experience drawn from phase III randomized trials.

quotes

Reply

Ted Okon (Posted: May 10, 2017)

quotes

Another company making the right move to control drug prices, especially in cancer. In community oncology we are advancing "value-based" payments for services. The same thing needs to be done for drugs. It's time for those really wanting to advance the quality and affordability of cancer care to step up and innovate.

quotes

Reply

Ted Okon (Posted: May 10, 2017)

quotes

Scott Gottlieb is an excellent choice to head the FDA. He has served there before and his prior government experience coupled with his business background provide him with the skill set necessary to modernize the FDA. The comments about his ties to the pharma/bio industry being a negative are absurd and just politics. You want someone who knows the industry from the inside, just like you need a Treasury Secretary who knows Wall Street.

quotes

Reply

Winston Wong, PharmD (Posted: May 08, 2017)

quotes

Definitely a very volatile topic. PBMs control a good part of the prescription claims process, but it the back room negotiations with regards to rebate's, etc that require more transparency. However, not everything can be pinned on the PBM. Bottomline is that everyone has a stake, and has contributed to the high prices.

quotes

Reply

Richard Goldberg, MD (Posted: May 05, 2017)

quotes

This is a very interesting study that opens the door to prospective investigation of a randomized trial of watch and wait strategy versus surgery in patients with low stage rectal cancers who have complete responses to chemotherapy and radiation. Identifying patients who can be spared the cost and toxicity of triple modality therapy with good outcomes is key.

quotes

Reply

Thomas Marsland, MD (Posted: May 04, 2017)

quotes

Hi, all well, settling in in Petaluma. Thought I might comment on this. Data indeed is king. However, there are lots of sites out there that do provide the data. NCCN, Up to Date, to name a couple. CancerLinq, Flatiron, IBM/Watson, and others are also trying to do what is being proposed with Tempus. No question we need real-time data. Things are changing so quickly that even an extremely tech adverse guy like me is running to the cloud (I believe that is where I am going ???) to help me with treatment decisions.

quotes

Reply

H. Jack West, MD (Posted: May 04, 2017)

quotes

These results are very provocative, but we need a larger, randomized study to say anything more definitive about whether great activity of chemotherapy after rather than preceding immunotherapy is a reason to change how we typically sequence systemic lung cancer therapies. We will see far more studies of immunotherapy in the first line setting over the next few years, and it will be helpful to assess whether this finding is commonly demonstrated.

quotes

Reply

Darla (Posted: May 03, 2017)

quotes

I would be interested to see this.

quotes

Reply

H. Jack West, MD (Posted: May 01, 2017)

quotes

The data with brigatinib are strong, as this is an agent that has impressive activity against a broad range of secondary mutations in ALK preclinically, and clinically it is the first second generation ALK inhibitor that demonstrates a median progression-free survival beyond one year. Although the various second generation ALK inhibitors have yet to be compared directly to each other, the results with brigatinib are favorable in cross-trial comparisons. It is also typically well tolerated, though the potential for early pulmonary toxicity in the first few days requires attention and some caution (this is the reason for the escalation from 90 to 180 mg daily after one week).

But the landscape of ALK-positive advanced NSCLC is about to be transformed with the presentation of the results of the global ALEX trial, expected to be at ASCO. This phase III study of alectinib vs. crizotinib in ALK inhibitor-naive patients was recently noted to be positive for a PFS benefit with alectinib, and if it is even half of the demonstrated PFS benefit demonstrated in the smaller and Japanese-only J-ALEX trial reported at ASCO 2016 (Nokihara, A#9008), it should be enough to change practice and make alectinib the first line therapy of choice for ALK-positive NSCLC. That will leave brigatinib likely relegated to post-alectinib, where it may have far less activity than after crizotinib, since brigatinib and alectinib are both second generation ALK inhibitors and may have significant cross-resistance between them.

It's certainly great to have another effective ALK inhibitor available for patients, and we'll need further data to see how brigatinib looks in first line (trial ongoing, vs. crizotinib) as well as its activity after alectinib. We'll also need to keep an eye out for lorlatinib, a third generation ALK inhibitor with activity even after acquired resistance to second generation ALK inhibitor therapy, and other ALK inhibitors in development.

quotes

Reply

Howard S. Hochster, MD (Posted: April 27, 2017)

quotes

It is not difficult to imagine that PARP inhibitors, which function through the Homologous Repair pathway, would not add much to standard platinum based therapy in unselected lung cancer and TNBC. What is harder to imagine, is what AbbVie would launch phase 3 trials in unselected patient populations who do not have defined DNA repair defects. We can do better in this era of tumor profiling.

quotes

Reply

Howard S. Hochster, MD (Posted: April 26, 2017)

quotes

Fascinating legal wrangling as the Supremes parse the wording of the BPCIA (Biologic Price Competition and Innovation Act). At stake, whether the biosimilar manufacturer must supply the originator company with a copy of their BLA application, and whether an additional 180 day waiting period Is required following actual FDA approval of the biosimilar for the originator to issue patent litigation. This would invalidate notification prior to the formal licensure.
Who knew biosimilars could be so exciting and reach SCOTUS ??

quotes

Reply

Winston Wong, PharmD (Posted: April 25, 2017)

quotes

Generally, when a Physician indicates a "Dispensed a Written", on a prescription, it is honored by the health plan and the member pays the branded copay. On the other side of the table, members also ask for the brand out of pure preference, which is what payers are focusing on. Obviously, in this case, if the article is accurate, no DAW code is being recognized.

quotes

Reply

Dean Gesme, MD (Posted: April 21, 2017)

quotes

This will only determine how much delay is allowed by the courts and how excessive the legal expenses will be for every new biosimilar to enter the market. If the point is saving money while saving lives, how has our legal system gone so wrong?

quotes

Reply

H. Jack West, MD (Posted: April 20, 2017)

quotes

The failure of the phase 3 trial with veliparib combined with chemotherapy is disappointing and yet another reminder of the gulf between promising phase II data and proven benefit in a larger, multicenter phase III trial. This was a large and likely well-conducted study that asked an important question and provided a valuable but humbling answer. Despite recent successes with checkpoint inhibitors and some targeted therapies, it remains quite challenging to generate clinically significant improvements in outcomes in patients with lung cancer.

In the future, trials will increasingly need to focus on more narrow populations as the treatment algorithms incorporate PD-L1 expression and more driver mutations with different standard treatment approaches.

quotes

Reply

Winston Wong, PharmD (Posted: April 19, 2017)

quotes

So lets take a different, more cynical approach to the flat trend being observed. Yes, I'll grant that there might be something to the advance utilization management programs. But, should we also take into account that as drug costs increase, so does patient liability, which means maybe trends are flattening because patient cannot afford to pick up their prescriptions, hence no cost is recorded. As well, we are only looking at the prescription benefit side. Much of the sensitivity surrounding drugs cost are under the medical benefit, so are we looking at the entire picture? I think not. Maybe we need to take a step back and look at cost from a much broader view.

quotes

Reply

William McGivney, PhD (Posted: April 12, 2017)

quotes

The developers of Value Metric Frameworks continue to struggle to make them relevant and also to make them usable and utilized by a meaningful number of policy-makers and clinicians. In the MedScape article, the key point was made with surprising honesty by ASCO’s Dr. Grubbs who was quoted regarding the ASCO Value Score Framework:
“The organization is working to include cross-trial comparisons”, said Dr Grubbs. "Until we have that, there's going to be limited benefit to this.”
This was an obvious observation made by many when the ASCO Value Score Model was first introduced. Mandating the use of head to head comparator trials as the source of data and other limiting characteristics created a model that once again ended up as confirmation of the saying, “The Perfect is the Enemy of the Good”.
In what I called “The Rush to Value” in my analysis for a journal in July of 2015, organizations and individuals raced to the spotlight for presumptive crowning as “Value Czars” with incompletely thought-out products. Here we are two years later and these products languish. Actually, the one product that still has “legs” is the ICER analytical model. However, any momentum that ICER had was substantially diminished by the results of the 2016 Presidential election.
The pronouncement that many oncologists do not know the price of the drugs that they prescribe continues to amaze me. I submit that this population of docs will not be interested in understanding and reviewing results of the many “Value” Models out there. For the others, a simple statement of Price will probably facilitate the prescriber’s understanding of the Value of what she/he is prescribing.

quotes

Reply

H. Jack West, MD (Posted: April 10, 2017)

quotes

In the wake of the highly positive preceding phase II version of this trial in Japanese ALK-positive patients (J-ALEX), we debated whether these results were compelling enough to warrant a change in first line treatment of ALK-positive but ALK inhibitor-naive patients. While that remains debatable, many thoughtful observers of this space have favored waiting until we obtained results from the larger and more demographically/geographically diverse phase III ALEX trial of alectinib vs. crizotinib, which also studied the global standard dose of alectinib (600 mg PO BID) rather than a unique lower dosing (300 mg PO BID) studied in the Japanese only population.

We need to see the data, and I hope and expect that will occur at ASCO 2017 (in either the lung cancer oral abstracts on 6/6/17 or, even better, as part of the Plenary program on 6/4/17). However, now knowing that this trial was positive, as we had expected, these results should be enough to shift alectinib to become the standard of care for first line treatment of advanced ALK-positive NSCLC in the coming months.

quotes

Reply

Winston Wong, PharmD (Posted: April 07, 2017)

quotes

A commendable increase of 28 months of survival ... and the overall cost is? Not trying to put a price tag on improved survival but we have to consider the cost of the combination regimen, at least from the patient perspective. As for the difference between the BMS and Merck products, payers believe the difference lies in the study design and the PD-L1 testing.

quotes

Reply

Winston Wong, PharmD (Posted: April 02, 2017)

quotes

Agreed that the individual patient may see relief. The bigger picture is that if the individual patient does not pay the higher copay, the cost is spread across the entire insured population in the premium. At the end of the day, the costs are high and someone ends up paying for it.

quotes

Reply

William McGivney, PhD (Posted: April 02, 2017)

quotes

As we now rest “comfortably” in the “Valley of Value-Based Policy-Setting and Decision-Making”, it is quite reasonable to evaluate the benefits of providing organizations like AHRQ with half-a-billion dollars a year and compare how such health care dollars might be better (or not) spent. While one is at it, one might as well throw in PCORI to this evaluative and valuation effort. My experiences with AHRQ are based upon my serving as a reviewer for a grant about 12 years ago, a meeting I had with AHRQ folks when I was CEO of a national organization, my experience with the work product of a large contract let by AHRQ, and general tracking of the agency as it changed names through the years. I started to describe those experiences but thought better of heading down that path. In the briefest of my comments (ever), I believe it is a good time to evaluate the products of these agencies and the Value that they might provide.

quotes

Reply

Winston Wong, PharmD (Posted: April 02, 2017)

quotes

Ok. So maybe the there was a bit of overexcitement from NantKwest's product. Let's look beyond that and see what the total umbrella of NantHealth is aiming for ... a totally integrated decision support tool, with all of the bells and whistles one could ever imagine or want. In the end, is there an ROI, or will it just be placed alongside of the the other decision support tools, waiting for true clinical utility and an ROI to be proven. IT integration is a powerful tool, and as of yet, we have not achieved it in reality, but at least NantHealth is setting a vision.

quotes

Reply

William McGivney, PhD (Posted: March 30, 2017)

quotes

The issue of offering access to “investigational” treatments for serious and life-threatening illnesses is a very difficult issue from a clinical perspective, especially with respect to the provision of a treatment with an ill-defined adverse event profile. However we must remind ourselves that we are talking about people with serious and life-threatening illnesses such as ALS, lung cancer etc.
There are ways to and examples of how the issue has been addressed. Clearly, the FDA has compassionate use guidelines. Further and even better, during the rise of the AIDS epidemic in the 1980s, the FDA produced and finalized the Treatment-IND regulation that made drugs that had shown some early efficacy and had been granted the Treatment-IND designation available to patients with AIDS before FDA approval. The road to finalization of the Treatment-IND was a controversial and a rocky path; but it happened.
In my view the Treatment-IND, pushed by then Commissioner Frank Young, MD, was successful in terms of offering hope to patients, establishing a bridge to possible better drugs, and spurring on innovative research, especially the involvement of smaller biotech companies. The support of the American Medical Association was key and I was fortunate to be the FDA liaison for the AMA at the time and work with Stuart Nightingale, MD Associate Commissioner for Health Affairs at the FDA.
I took the lessons from that experience with me to Aetna in 1991. Six days after joining Aetna as VP Clinical and Coverage Policy, Aetna was on “60 Minutes” for the second time for having denied coverage for high dose chemotherapy/bone marrow transplant. I was charged with addressing the issue of the use of investigational treatments in patients with less than a year to live. The bottom line was the establishment in 1991 of the Aetna “Terminal Illness Policy” whereby investigational treatments, especially HDCT/BMT, were evaluated on an individual patient/beneficiary basis for patients with limited life expectancies. The limit of life expectancy was treated with great flexibility. This program was highly successful and well-respected by patient groups, providers, other payers, employer customers, state legislators, etc. A modified version of this policy still exists at Aetna.
Through it all, I learned one of the commandments for my decision-making in setting coverage policy and making individual patient medical necessity determinations at Aetna:
“The more serious and life-threatening the illness, the lesser degree of certitude about efficacy and the greater risk of harm about treatments that patient, provider and payer should accept.”
This real-world commandment came into decision-making play every day and still does.

quotes

Reply

Dean Gesme, MD (Posted: March 27, 2017)

quotes

Speaking from experience as a patient, I would much prefer an MRI of the prostate to investigate an elevated PSA prior to proceeding with an prostate biopsy!

quotes

Reply

Fred Pane (Posted: March 27, 2017)

quotes

It isn't President Trump or any other politician/political party that suffers with these issues, it is the American people. Politicians are making decisions for 10 of millions of people and they have the best healthcare in the country. The ACA, a traditional bill which also had a lot of pork belly in it, besides healthcare, was approved without even being read by the politicians we elected. Would you run your business or even home that way? "We will read it later was what the politicians said". Did they read it and make changes before implementation, years after approval? There is no rush to repeal ACA but there is a need to develop a model of healthcare for all citizens of the US, who elect Democrats and Republicans. No one in DC is deserving of their job right now. Meet with your constituents and listen to them. We need to build a better, stronger country. I am commenting, because I did give 60 minutes of input to aides, for two senior senators on ACA and was disappointed to speak with aides, who were going to translate what I said and knew nothing about healthcare, to these two Senators? We pay these people to know what they are voting on. Not to have aides give cleft notes from meetings.

quotes

Reply

H. Jack West, MD (Posted: March 24, 2017)

quotes

It's striking that we've needed yet another revision of the NCCN guidelines in NSCLC, but this is a reflection of how rapid the progress has been in the field. Adding PD-L1 expression testing at initial workup, including revised indications for the second line use of the various PD-1 and PD-L1 inhibitors, and including data on the very clear positive results for osimertinib in T790M-positive acquires resistance after first line EGFR Takis -- these are all valuable additions. Whether frustrating or encouraging, additional revisions will likely follow in the coming months, as new data lead to further rapid evolution of our standards of care in advanced NSCLC.

quotes

Reply

RMT (Posted: March 23, 2017)

quotes

No proven benefit for protons over IMRT and IGRT for oropharyngeal cancer, so I have no problem with insurance denial.

quotes

Reply

Thomas Marsland, MD (Posted: March 20, 2017)

quotes

This report again confirms what we all suspected. That there are indeed significant savings to the "system" when practitioners take the responsibility to direct appropriate care themselves. This as discussed involved standardization of how the practice deals with patients that have "pathways" in place for triage and treatments. Also having expanded access by the patients to the physicians and other caregivers in the practice. No longer is it acceptable to have a recording say "hang up and dial 911" or have the practice on-call person say "go to the ER." WE have to be there for our patients. If we really do this and take responsibility, indeed this can result in reduced costs of care. HOWEVER, there have been numerous examples (Drexel, Wilshire and others) that also clearly show that the costs to the practice are significantly increased. Obviously in any new payment model these increased costs have to be recognized. In addition, these three newer models should be included as potential options for new APM's.

quotes

Reply

Oscar (Posted: March 17, 2017)

quotes

I hope the medical community rises up against this horrendous budget and unconscionable "healthcare" act. If anyone has influence over healthcare legislation, it is the medical community. Time to use it.

quotes

Reply

Dean Gesme, MD (Posted: March 17, 2017)

quotes

Surely defending our country's medical health warrants expenditures as great as defending our country's borders from immigrants or foreign aggressors!

quotes

Reply

H. Jack West, MD (Posted: March 10, 2017)

quotes

We still have more questions than answers about the potential for patients to "hyperprogress" after exposure to immunotherapies, but this has been reported elsewhere (Champiat, Clinical Cancer Res, 2016), and several clinical groups have reported that they have anecdotally noted this phenomenon at their centers, some even noting that they are working on preparing manuscripts that characterize it more fully. This concept will be critical to understand better, especially as immunotherapy moves earlier into and more broadly across treatment paradigms in many cancers.

quotes

Reply

Winston Wong, PharmD (Posted: March 09, 2017)

quotes

I am not sure that the consolidated billing for biosimilars is a good idea, mainly because these drugs are not interchangeable. Using a single consolidated J-code will imply that these drugs can be substituted for each other, and they are not. I am also concerned that using the WAC will eventually lead us back to the issue we saw with the inflated AWP.

quotes

Reply

Winston Wong, PharmD (Posted: March 09, 2017)

quotes

While I applaud Walgreens for putting together a focused effort in supporting the oncology patient, I am still concerned about the coordination with with oncology practice and their navigation efforts. All practices do not necessarily have medication support monitoring within their four walls, so the Walgreens program is a much needed gap filler. I guess it also goes to state that I hope that the pharmacists are able to dedicate the time to these patient, and not have to be worried about productivity numbers.

quotes

Reply

Thomas Marsland, MD (Posted: March 08, 2017)

quotes

Wow.... maybe MedPac actually came up with a couple of good thoughts. This article is definitely worth looking at. They address the ASP issue and rising drug costs by limiting the amount the company may increase the price in a given period of time. This is a dramatic change from the idea that they can control drug costs but reducing the add on (ASP "+") that is the fee to the practice for drug handling. I like the idea of consolidated codes. It clearly has been helpful in the generic world and if done properly should work for biosimilars and even drugs within a give type that have equal efficacy and toxicities. The DVP idea is also one that deserves being looked at (darn, lot of dangling pariticiples today...). This is one way of allowing Medicare to "negotiate" pricing through an intermediary. The proposal removes the outside negotiating vendor from the direct patient billing and issue of drug procurement for the practice that was very problematic in the CAPS program.
Clearly the "administrative" fee would need to be adequate to cover practice expenses on drug handling but we should be open to the idea. It would be interesting if this did then qualify as an APM. It wasn't really clear in the report if that was just an idea or was that a key part of the proposal. The final piece of this article that was very interesting was the discussion of a "virtual" group - a concept I had only very recently heard of ( darn again...). Once more the devil is in the details. Who is in the group??? What metrics are being looked at??? This would go a long way toward being sure that in any performance based payment model that you really are being compared to your peers in terms of quality outcomes and costs. No longer would the oncologist be compared to the internist. Gee maybe MedPac isn't so worthless after all......

quotes

Reply

H. Jack West, MD (Posted: March 06, 2017)

quotes

I'm dubious about a 62% specificity. The test doesn't conclusively rule out cancer, nor does it establish what we would consider to be a conclusive diagnosis. being priced aggressively, at 75-80% the cost of a biopsy estimated to cost $15K, I don't think this test will give 75-80% of the value of a biopsy. I am dubious it will emerge as a widely adopted test, at least at the aggressive price point at which it is being offered.

quotes

Reply

Winston Wong, PharmD (Posted: March 04, 2017)

quotes

Most health plans require oral oncology agent to be dispensed through their specialty pharmacy program, with the promise by the specialty pharmacy for close monitoring for adverse effects and adherence. The problem, however, is that the oncologists are not kept informed of the patient issues, nor are they informed of a break in therapy. When the oral med is filled by the SP, a major disconnect usually happens. Maybe more effects is needed to provide integrated comprehensive care, as opposed to putting up barriers to oncology practices to stop them from coordinating the care of their patients.

quotes

Reply

Dean Gesme, MD (Posted: March 02, 2017)

quotes

Aphinity is expected to be practice changing for Her2 positive early breast cancer patients not already treated with these agents in the neoadjuvant setting. I anticipate this to be a Plenary presentation at ASCO 2017.

quotes

Reply

Thomas Marsland, MD (Posted: March 02, 2017)

quotes

Boy are we a mess....... 30% of us are drunks, 20% drug addicts, and another 20% are crazy. Ok so maybe a tad dramatic... but burn out and stress are clearly an issue. I personally don't believe the dealing with dying patients is the most stressful part of practice. Hospice physicians and palliative care doctors didn't seem to have quite the same degree of problems yet they deal with end of life all the time also. For me the biggest stress producer is the constant battle with the regulatory agencies (payers and government) that continually put barriers in place that make good care more difficult. Stress itself is not always a bad thing. It can be a strong motivator for action. For me adequate time off to spend with family is critical. I think that we do need to be sure that as part of any training program that students and fellows are taught the importance of time off and relaxation. At this point think I will retire to the couch with my single malt.

quotes

Reply

Thomas Marsland, MD (Posted: March 02, 2017)

quotes

At this point the OCM is the only oncology specific APM available. The article I think clearly points out some of the issues that this and probably any APM presents. The coordination of care, the extra time and effort in patient follow up, and the documentation of "quality" measures really do present a burden on physicians and practices. In the end I do believe the patients get better care but if these programs are to be successful we need to be sure that the extra services provided are recognized and adequately compensated. As an aside one needs to point out that unless the practice accepts the two sided risk model the OCM really doesn't qualify as an APM. This also potentially puts the practices at an additional economic disadvantage as they take on more costs to provide the added services with no guarantee that they will be compensated.

quotes

Reply

Richard Goldberg (Posted: March 01, 2017)

quotes

This finding may make us rethink screening guidelines that already call for African Americans to begin screening at age 45 because of that group's propensity for earlier onset disease. Additionally genetic screening for heritable predisposition to colorectal cancer is particularly vital in those with early onset cancer to permit the development of individualized screening recommendations for family members.

quotes

Reply

Winston Wong, PharmD (Posted: February 28, 2017)

quotes

This is a 2-edge sword. I an hopeful that we will continue the movement towards value-based care. I am not all together confident that value based care will help justify drug pricing. One can say that NICE already evaluates drugs in this way, and as a result, many drugs are not covered, or are under limited access due to the heavy discounts the manufacturers have offered. If it takes a significant discount to even be reconsidered by NICE, would that not be interpreted that the value is not present under the original pricing. With that said, we all know our pricing is higher here in the US. I think we might have a false hope here.

quotes

Reply

Winston Wong, PharmD (Posted: February 28, 2017)

quotes

Pre-existing conditions and lifetime patient maximums are major hot points of concern these days, for good reason. And while the insurance mandate is designed to balance out the risk pool, one has to ask is it enough of a balance. I completely understand the issue of the patient financial burden, but the bigger part of the story lies in the fact that healthcare is expensive, especially in Oncology. If the patient does not have to bear any of the burden because of being an essential benefit, then where will the cost be absorbed? Using the 80/20, or even the 10/90 rule, a lot of insured health folks are needed to really balance out the risk pool.

quotes

Reply

Thomas Marsland, MD (Posted: February 16, 2017)

quotes

There is no free lunch (unfortunately). I would like to comment on actually two reports in today's OBR that reference Dr Workman's paper on "how much longer will we put up with $100,000 cancer drugs?" Clearly current drug pricing is unsustainable and if allowed to continue will ultimately result in limitation of access in some form. I am not sure that the idea of using academic centers would really lower the costs of development. There is little data to suggest they can do it more cheaply. The authors talk about partnering with private companies in the development process but clearly these companies are going to be looking for a return.... profit. Perhaps the expected returns may be less than traditional pharma but that remains to be seen. So some concepts that also perhaps need to be explored. I agree that the research process needs to be streamlined. With targeted treatments, as the authors suggested, one may not need the huge, expensive trials that have traditionally been done. It would be useful to look at drug costs in the approval process. If a new drug is not significantly more effective or less toxic then perhaps it should show a cost advantage to get approval. We need more transparency in how drugs are priced. Certainly what the "market will bare" is one large determinant now. How much of the cost is determined by marketing (direct to consumer ???, see prior comments) and not actual development. Allowing negotiations for the cost of drugs by the government would also be big step in controlling pricing. So clearly we need to do a better job of pricing cancer drugs.

quotes

Reply

William Harwin MD (Posted: February 15, 2017)

quotes

At Florida Cancer Specialists we have been using DigniCap for several months at 3 of our site and it does appear to be a real advance in preventing alopecia from chemotherapy. I just completed treatment with 6 cycles of TCH + Pertuzumab in a woman with breast cancer with a full head of hair at completion of treatment. The problems with DigniCap are the cost and lack of insurance reimbursement. It may not be fully effective in all patients especially with an Adriamycin regimen.

quotes

Reply

H. Jack West, MD (Posted: February 09, 2017)

quotes

What is most remarkable is how many successes we've had with immunotherapies across a wide range of cancers over the past few years. That investors are losing money due to results falling short of expectations is far more a product of the irrationally exuberant, even delusional expectations of many in the financial sector than on the failure in an absolute sense of immunotherapies relative to what should have been realistic expectations for a medical intervention.

quotes

Reply

Winston Wong, PharmD (Posted: February 08, 2017)

quotes

Keep in mind that Express Scrips is a PBM, monitoring ambulatory prescription cost. These are mostly self-administered, with some mixing in of medications under the medical benefit. Significant increases were noted in the Oncology and anti infective arena, which are mostly under the medical benefit, hence is not being readily tracked by the PBM. I would surmise that if the overall medical spend was tracked, the level of increase would be higher.

quotes

Reply

Winston Wong, PharmD (Posted: February 08, 2017)

quotes

The DIR reporting process was intended to increase the level of transparency throughout the prescription transaction process. As with all good intentions, reality never seemed to occur. It is now a convoluted process that is just as murky as the overall rebate process. The ramifications are far down stream, impacting pharmacies, in addition to the overall cost to the patient and payers. Diplomat Specialty Pharmacy was hit hard last year due to what was called a DIR pullback by a PBM. So much for Transparency.

quotes

Reply

H. Jack West, MD (Posted: February 06, 2017)

quotes

It is disingenuous for the media to paint erlotinib (Tarceva) as a completely ineffective and inappropriately marketed drug when what actually happened was that the FDA approval was based on a significant overall survival benefit for erlotinib over supportive care in an unselected population (conducted before we even knew of EGFR mutations), followed by many subset analyses that demonstrated modest but consistent efficacy even in patients with squamous NSCLC (who almost never have EGFR mutations) and those with EGFR wild type. Was it remarkably effective? Not at all. Were oncologists enthusiastic about it? No. But it wasn't until a much later study indicated no significant benefit that one would definitely say that the preponderance of evidence shifted away from treatment of EGFR wild type patients with erlotinib.

In addition, the EGFR mutation test is not perfect. I have had several patients who tested negative for an EGFR mutation on initial workup who later received 2nd or 3rd line erlotinib and enjoyed a spectacular, long-lasting response. In a few cases, later testing showed an EGFR mutation previously missed. Those patients would have almost certainly died years earlier without the benefit of the opportunity to receive erlotinib.

Whether one was actually a proponent of EGFR TKI therapy in EGFR mutation-negative patients or not, it is revisionist history to act as if our current perspective should have been held based on the less extensive evidence available in the past. Moreover, oncologists, patients, and the mass media still regularly sensationalize treatments without a scintilla of evidence outside of a rare case of a patient doing well.

It is the height of hypocrisy for these same oncologists, patients, and mass media to now act indignant that the level of evidence was insufficient to justify using erlotinib, while everyone clamors for off-protocol use of immunotherapy or other new therapies beyond current indications based on wild-eyed optimism and far, far less evidence.

quotes

Reply

Thomas Marsland, MD (Posted: February 06, 2017)

quotes

I am no fan of direct to consumer advertising. The article very nicely address a number of the reasons. Clearly no physician would not discuss the use of immune therapy in patients for whom it is indicated. On the other hand no one would order any treatment that isn't efficacious just because the patient saw it on TV. My question that has not been addressed is how much does this advertising add to the cost of the drug. Drug costs today are skyrocketing and although not clear to what degree but large marketing budgets certainly don't help cost controls.

quotes

Reply

Winston Wong, PharmD (Posted: February 06, 2017)

quotes

While these penetration numbers are encouraging and impressive, it would be interesting to see the details e.g. what is defined as value based care, and what is the metric that drives the reimbursement. The interest here is that there really is not any accepted standard definition of value-based care. So it could be anything that is not fee-for-service.

quotes

Reply

Joan Keit MD (Posted: January 31, 2017)

quotes

It is unethical to advertise cancer drugs to the general public. As a radiation oncologist, I have patients routinely ask me if they can have Optivo because the TV commercial leads them to thing it is the miracle cure. The lay person cannot possibly be able to decide his/her own best cancer therapy. Advertising is a waste of money in an environment where many drugs are already prohibitively expensive.

quotes

Reply

Winston Wong, PharmD (Posted: January 31, 2017)

quotes

The issue here is that if the government were to be able to negotiate discounts, it would take a massive overhaul of the current programs. The piece touched on it, but did not specifically state that major changes in the entire system are needed to be able to put radically new programs in place. However with that said, even if discounts could be negotiated with all of the other classes outside of the six protected classes, saving could be realized. Insurance companies do that today. Finally on the topic of transparency, many States have regulations in place. No one knows how to enforce them.

quotes

Reply

Thomas Marsland, MD (Posted: January 30, 2017)

quotes

So having the advantage of 35 years of practice has allowed me to see many different models of practice. I have been in a true multispecialty group, a small single specialty group, large corporate models (as being described), a large single specialty practice, and a large cancer focused multidisciplinary practice. The article leads off with a comment about "independent community based providers." My question is: "Is that model viable going forward?" Having watched my market evolve I am very skeptical that even with the power of a large national company that "independent community providers" will be around in the future. Certainly in some markets - yes. However what I have seen is the large hospitals form their own healthcare systems playing hard ball in a way that either you join them or they go out and bring in their own (non independent) oncologists. At best I see community docs as part of carved out joint venture with a local system (all politics are local as is healthcare delivery). Today even with a multidisciplinary cancer focused practice it is hard to provide all of the services: cancer prevention, diagnosis, treatment and support required. Many other specialties and supportive care providers are needed. Hospitals and "systems" are not going to let that business go. As one who grew up in the "buy and bill" days, I am saddened by these changes but we have to adapt and be involved for our patients and ourselves.

quotes

Reply

H. Jack West, MD (Posted: January 27, 2017)

quotes

It's not surprising that the second line NSCLC market has shifted away from nivolumab to atezolizumab and pembrolizumab from nivolumab enjoying the overwhelming majority of that market share a year ago. The recent presentation of newer data and subsequent FDA approvals have meant that atezolizumab is now a second line option given on a more convenient every 3 week schedule vs. nivolumab's every 2 week schedule, while both have no requirement for any PD-L1 testing or a threshold level of expression. Even though pembrolizumab requires at least 1% staining for second line use based on the revision of that indication, the new approval of pembrolizumab as first line therapy for high PD-L1 expressors means that the vast majority of NSCLC are now being routinely tested for PD-L1 expression in their initial workup as a standard of care, whereas PD-L1 testing was not previously a necessary step. This means that pembrolizumab, as another every 3 week option, compares favorably as an alternative to atezolizumab for any patients with > or =1% PD-L1 expression.

Finally, though the negative results from Checkmate-026, comparing nivolumab to standard chemotherapy in first line NSCLC, do not speak to the second line setting, it is likely that this has led to somewhat lower enthusiasm toward nivolumab when comparable checkpoint inhibitor options have a more attractive treatment schedule and have not been tainted by negative first line results, at least not yet.

quotes

Reply

Winston Wong, PharmD (Posted: January 27, 2017)

quotes

In some respects, maintaining the value-based momentum and smoothing gout the prior authorization process go hand-in-hand. We are putting the decision making process back into the hands of the physicians who are working within the performance and financial parameters benchmarked.

quotes

Reply

Winston Wong, PharmD (Posted: January 27, 2017)

quotes

This study provides the rationale for the need to implement patient navigation programs to assist the patient through their journey.

quotes

Reply

Dean Gesme, MD (Posted: January 25, 2017)

quotes

A very welcome advance in HCC therapy with lenvatinib dosing which is lower than the initial recommended dosing for radioiodine-resistant well differentiated thyroid cancers. Much greater expense may be an important issue compared to sorafenib. Also the second line role of regorafenib may need some further consideration versus using sorafenib in the second line.

quotes

Reply

William McGivney, PhD (Posted: January 25, 2017)

quotes

Support received by organizations from various stakeholders for educational programs and other activities at provider or patient not-for-profits is a valid issue, especially when such an organization(s) might have considerable influence over practice norms and coverage policy.
However, it is always interesting to note the amblyopic view of researchers and the media who focus their efforts only on one side and the easy target. When I was CEO of a major provider organization, I decided to address my limited curiosity by having each grant request (for mainly educational programs) that was sent to a pharma company be also sent (the same grant request) to major payers. One year at our Annual Conference, I was listening to a Panel discussion addressing this issue and was compelled to make a public comment.
The organization had sent over thirty requests for support for educational programs to major payers and we had a uniform answer to all such requests. That answer was “NO”.
I suggest that researchers make sure that they understand the entire system and not close the one eye that should hold a field of vision that includes other stakeholders (e.g., payers) in their quest for veracity.

quotes

Reply

H. Jack West, MD (Posted: January 25, 2017)

quotes

My annual family newsletter has higher standards for newsworthiness than a press release saying a trial is ongoing.

quotes

Reply

Winston Wong, PharmD (Posted: January 24, 2017)

quotes

Not that I am against the concept of biosimilars, but once a manufacturer meets ALL of the requirements for interchangeability consideration, will the biosimilar still be lower in cost?

quotes

Reply

H. Jack West, MD (Posted: January 23, 2017)

quotes

A brilliantly insightful, balanced commentary. Full disclosure: I wrote it.

quotes

Reply

Thomas Marsland, MD (Posted: January 23, 2017)

quotes

For every ying there is a yang...... so the ACA may well save some lives but the other side of the coin is also true. I believe that all the added rules and regulations put on us by the ACA often results in treatment delays that could cause lives being lost. The prior auths and pre certs that come the all the low cost Obama care plans certainly cause treatment delays. the degree of ridiculousness cannot be exaggerated.... I actually had to get authorization for a urine analysis the other day. Gosh I must be getting rich ordering UA's. On a more somber note I actually had a patient with a hepatoma that with all the road block thrown up by the insurance company actually took 5 months before she received any treatments at all. Her prognosis was dismal to start but the 5 month delay certainly didn't help. It actually got so bad that I had to go the state insurance commissioner before we had any movement. So as I said just be careful there are always two sides to every story.

quotes

Reply

Winston Wong, PharmD (Posted: January 19, 2017)

quotes

There is no doubt in my mind as to what the benefits are for generic profiling, both from Tissue and circulating cells. The ability to identify the cancer type, predict treatment response, and monitor response is priceless. However with that said, as we move into this era of personalize medicine, we still need to keep in mind that the price of the assays may be coming down, but the equipment is still pricey. Hence we still need to identify and assay for the most meaningful genes to report the most useful data that will drive treatment decisions.

quotes

Reply

Howard S. Hochster, MD (Posted: January 17, 2017)

quotes

The Supreme Court ruling is important in the coming era of biosimilars. This is an area where the Supremes should be educated on the difference in the approval process for biosimilars versus generics. In the case of biosimilars, the sponsor of the new agent is not only required to support extensive manufacturing data, mechanistic data and composition within tolerable manufacturing bands compared to the originator compound, but they must conduct expensive and time-consuming clinical trials to show clinical equivalence to the originator compound. Biosimilar compounds are named individually with a suffix to the international name so they can be individually distinguished. The extra 180 waiting day for generics should not be extended to biosimilars. They are actual new drugs requiring extensive testing and individual naming.

quotes

Reply

Winston Wong, PharmD (Posted: January 16, 2017)

quotes

It maybe the first step, but it is a baby step. We need a replacement to be created, and then the repeal cannot just happen over night. It took many years to get to where we are at. We can't just undo it all overnight.

quotes

Reply

Winston Wong, PharmD (Posted: January 11, 2017)

quotes

Sometimes we need to be careful for what we ask for. Allowing Medicare to negotiate price discount may lower costs for Medicare, but on the flip side, if manufacturers are allowed to set their target financial goals, the backside of Medicare discounts is less discounts for the commercial business. So while Medicare cost are blunted, the overall cost of care may not really change all that much.

quotes

Reply

H. Jack West, MD (Posted: January 11, 2017)

quotes

I'm not a fan of this approach based on the limited data we have. First, this fining is predicated on a trial with only 123 patients. Though PFS was better with combined chemo and pembrolizumab, there was no difference in overall survival, despite the fact that only 32% of patients assigned to first line chemo had crossed over to get pembrolizumab in the published report (Langer, Lancet Oncol 2016). Moreover, toxicity was clearly greater in the recipients of chemo/pembrolizumab combination. Finally, the concept of maintenance pembrolizumab/pemetrexed indefinitely, with it quite likely that only one of these extremely pricey agents is driving the ongoing benefit but no way to determine which, means that the cost of this treatment is extremely high and buys many patients only the added cumulative toxicity of further treatment with at least one agent that they are not benefiting from significantly.

This is clearly a shrewd marketing move for Merck, trying to broaden their first line claim from 28-30% of the patients, a subset that is particularly likely to benefit from immunotherapy, to the vast majority of NSCLC patients. But it is an assault on the concept of precision medicine that prioritizes corporate interests and squeezes out other companies and agents that have a competing claim in second line.

The key issues are a short term response rate and PFS benefit with far greater net costs, significantly greater toxicity, and no evidence of improved survival, especially if all of the patients assigned to first line chemo were to actually get the checkpoint inhibitor therapy that they should in the second line setting. It is a campaign of marketing interests over refinement of treatment that is truly best for the patient.

quotes

Reply

Thomas Marsland, MD (Posted: January 10, 2017)

quotes

Well its a new year but still the same problems. The cost of cancer drugs really is a huge problem. I am glad the misdirected ASP demo project was nixed but the price of new therapies is still an issue that needs to be addressed. We all talk about value and indeed we have made significant strides in helping to define value but the second piece to the value equation is affordability. Even if new agent has value, can we afford it? Not everyone can drive a Rolls. My biggest concern as we move into newer payment models is that they will include bundling and episodes of care that put practices at risk and may force "me" to tell a patient that they cannot have a new treatment because my practice cannot afford it. It makes one wonder if a NICE type program could ever happen here. I certainly would prefer to have the backing of some outside organization that has made the decision that a specific treatment is not "affordable" rather than it being solely based in my specific practice economics. The article also make some very good comments on how much of what we do is still not adequately recognized as valuable in many of the newer compensation models. We need to be sure that future payments do adequately cover our cost for regulatory reporting, care coordination, increased patient access, and many of the other increased services needed to provide a good medical oncology "home".

quotes

Reply

Winston Wong, PharmD (Posted: January 10, 2017)

quotes

This presents an interesting question. While I understand the technology and potential ways that the liquid biopsy can be used to monitor tumor response to chemotherapy, will the results be trusted by peer review when the clinical utility of these tests have not yet been established?

quotes

Reply

Winston Wong, PharmD (Posted: January 09, 2017)

quotes

Round 2 of the drug pricing circus is beginning. I am pretty sure one thing. It is not the final bill of action that will get us. It will be the backroom deals that are promised to get the bill passed that will be the kicker.

quotes

Reply

Winston Wong, PharmD (Posted: January 09, 2017)

quotes

As I see more citations pertaining to the potential uses of the Liquid Biopsy platforms, I can only hope that the clinical utility of sure test will be demonstrated more rapidly that it has taken the general genomic profiling. Granted we need to find the appropriate tumors that the platform can be applied to, but once we identify those tumors, we need to use the technology.

quotes

Reply

H. Jack West, MD (Posted: January 06, 2017)

quotes

An important finding from the National Cancer Database, the report by Boffa and colleagues reveals that patients who start adjuvant chemo more than 8 weeks after chemo and even months later follow an improved survival comparable to that seen in patients who received adjuvant chemo starting within the target of 5-7 weeks following surgery, both groups having a superior survival compared to those who undergo surgery alone.

This is valuable to know because the clinical trials of adjuvant chemotherapy for resected NSCLC included patients who are disproportionately younger and more fit than we see in many real world clinics, and many patients experience complications and slower recovery. This leaves us able to consider adjuvant chemo only after a delay, and we have been left with only our judgment about whether that is helpful. Though retrospective, these data help answer that question and corroborate the finding of a benefit of adjuvant chemo in a broader real world clinical experience than studied in prospective trials with arguably non-representative patients, and they also suggest that we should extrapolate the favorable results of early administration of adjuvant chemo for patients who present to us beyond 7 weeks post-op.

quotes

Reply

Dean Gesme, MD (Posted: January 04, 2017)

quotes

Providers have a responsibility to fully understand the serious limitations of the tests which we are constantly being enticed to order based on theoretical promises of "patient benefit". We must see through the smoke and mirrors in order to fully comprehend the true state of new developments in order to justify the tests we do and then to correctly inform our treatment recommendations based on those tests.

quotes

Reply

Fred Pane (Posted: January 04, 2017)

quotes

I think we all need to realize, that ObamaCare/ACA should have been viewed as a starting point to try and further develop/evolve into a better model. There are pro's and con's to it when you speak to people actually using it. The ACA is a work in progress and needs to be viewed that way, but, it needs input from clinicians, consumers, etc. to evolve, not politicians. Healthcare and payer models continue to evolve and ACA will also.

quotes

Reply

H. Jack West, MD (Posted: December 22, 2016)

quotes

Applying artificial intelligence to immunotherapy efforts is like nuclear fission for hype... I hope it doesn't break the internet.

quotes

Reply

Sherronda Henderson, MD (Posted: December 13, 2016)

quotes

I am not a robot

quotes

Reply

Dean Gesme, MD (Posted: December 10, 2016)

quotes

It is encouraging to see three competing CDK 4/6 inhibitors soon to be available. With the huge potential market consisting of ER + great cancer, it will be a great case study in market pricing --- I.e. competitive capitalism vs collaborative market maintainance.

quotes

Reply

H. Jack West, MD (Posted: December 08, 2016)

quotes

Osimertinib was overwhelmingly superior to chemotherapy in terms of both efficacy and tolerability in T790M mutation-positive acquired resistance after initial EGFR TKI therapy.

There should be no question that osimertinib represents the optimal treatment approach here for such patients. Nevertheless, testing rates for EGFR TKI in the setting of acquired resistance remains only 30-40% in the US, far lower than it should be. With osimertinib restricted to T790M-posive patients, it is incumbent on oncologists to look for it, whether in tissue or in plasma followed by tissue if negative by plasma testing. To fail to test for T790M should be considered substandard care.

quotes

Reply

H. Jack West, MD (Posted: December 08, 2016)

quotes

Unfortunately, the ASCEND-4 trial had a trial design that essentially guaranteed a positive result, but also an arguably meaningless one. Crizotinib has already been shown to handily beat standard chemo in the PROFILE 1014 trial published by Shaw and colleagues in NEJM (?2015), making crizotinib a clear standard of care over the inferior option of chemo as first line treatment for ALK-positive NSCLC.

Consequently, showing you're better than a known inferior option is really damning with faint praise, especially when ceritinib was associated with very high rates of GI toxicity, including a problematic frequency of grade 3 or higher toxicity.

The fact that the median PFS is 16.6 is impressive relative to chemo, but it's also LESS than we could expect to get from first line crizotinib followed by ANY second generation ALK inhibitor, and both alectinib and brigatinib offer at least comparable efficacy with superior tolerability as 2nd gen ALK inhibitors. The ASCEND-4 trial is only enough to distract us momentarily before realizing ceritinib remains a poor choice with so many other ALK inhibitors available.

quotes

Reply

Debu Tripathy, MD (Posted: December 04, 2016)

quotes

These findings are an example of the power of genomic sequencing and bioinformatic analysis - with a small number of cases of testicular cancer, investigators at the Dana-Farber Cancer Institute were able to make two important, but still preliminary observations. One is that reciprocal loss of heterozygosity - that is, the simultaneous loss and gain of different pieces of the chromosome (presumably genes, or regulator of gene expression) can affect resistance to standard chemotherapy. The other (not so novel) is that p53, a well-known "guardian of the genome", is important for treatment responsiveness - many tumors that lose this gene function are more treatment resistant, and the rare hereditary loss of these gene spells risk for multiple cancers at very young ages. Of note, elephants were recently found to have multiple copies of p53 in their genome - perhaps protecting them to a greater extent from cancer).

This is the first step in a new trajectory - using this information to sort out what genes and pathways offer new targets. While we keep hearing about this general theme in publications and grants, the devil is in the details - it is not only about inhibiting one gene or protein, but modulating a multi-dimensional network, and one that probably varies significantly among individual tumors.

quotes

Reply

Thomas Marsland, MD (Posted: November 29, 2016)

quotes

Barbara's outstanding work confirms and cements what we have seen with the efforts of Linda Bosserman and John Sprandio. That attention to details, preventive interventions, standardization, and access can dramatically reduce costs of care and improve quality. Unfortunately these models provide many services not traditionally paid for by payers. In addition these added services significantly expand the costs to the practice. In the past those paying the bills have talked the talk but now they must walk the walk. I believe that we are moving in the right direction with many of the newer payment models. Hopefully we can preserve private practice where patients clearly get the most cost effective quality care.

quotes

Reply

Thomas Marsland, MD (Posted: November 29, 2016)

quotes

So as we head into the end of an eventful year, I still find that we have much to be thankful for, and much to look forward to in the coming year. I had the opportunity to spend Thanksgiving with a dear friend in the UK who is a leading psychiatric researcher (Ian Goodyear to any who may be interested). We've know each other since our days training together in the 70's. As usual our conversations started out about how one drinks good whiskey and degenerated into healthcare. It would seem that may of the issues are the same on both sides of the pond. They too have access problems with long waits and hard times getting patients needed care. They also have many of the same IT interoperability issues we are experiencing. Good care anywhere requires coordination, integration, and cooperation. I sincerely hope that the part D demo is indeed dead (holding my breath until they lower the coffin..) and that is a good thing but the take home message is that things must change. It cannot be business as usual. We as professionals need to take the lead and advocate for quality and value. Change is unavoidable. Regardless of where and how you drink your whiskey....

quotes

Reply

H. Jack West, MD (Posted: November 21, 2016)

quotes

It's important to note that the evidence supports making our clinical decisions far more based on performance status than chronologic age. With the median age of a newly diagnosed patient with lung cancer in the US in the range of 70-71, it's critical for surgeons and those who would potentially refer to surgeons to not dismiss a fit patient's candidacy for surgery based on age alone.

quotes

Reply

H. Jack West, MD (Posted: November 18, 2016)

quotes

This is an interesting observation that search terms on lung cancer symptoms are well correlated with subsequent searches for terms consistent with a diagnosis of lung cancer.

I'm not sure whether people will find this nore cool than creepy, that you can identify people highly likely to be diagnosed with lung cancer later, or the basis of search terms alone, but it suggests a potential value in targeting screening efforts in online ads around these search results that could potentially improve survival.

quotes

Reply

Thomas Marsland, MD (Posted: November 18, 2016)

quotes

I have heard it said that Data is King.... also GIGO (garbage in, garbage out); with that said it is truly clear that until there is truly an completely integrated system that tracks not only clinical outcomes but also practice costs, and charges any attempt at real health reform, is doomed to fail. The other key piece to this is that for any given patient that these data are available to all the stakeholders. That include patients, payers, and providers. Everyone has to be able to input and extract clinical and economic outcomes if we are to truly have cost effective care. Right patient, right treatment, right time....There are strong forces that are aligned against this interoperability because of their economic dependence on barriers. Fortunately organized medicine associated with some key members of our legislative family are addressing this. Perhaps in the not too distant future we will have a program that provides high quality cost effective care for all (regardless of last night's results - President Trump ????) (hey I voted for him...) (but I'm a right wing wacko).

quotes

Reply

Debu Tripathy (Posted: November 17, 2016)

quotes

The power tool of gene editing using the CRISPR (Clustered regularly interspaced short palindromic repeats) system has been used in the lab to generate cells with sculpted genes at a reasonably high fidelity. The ability to study a gene's functions and consequences of loss or gain of function or to even screen the effect of many genes has been greatly facilitated. The controversial use in humans is really an extension of ex-vivo manipulations that have already been in place with engineered cells - most notably chimeric receptor (CAR) T cells, which have yielded impressive results in clinical trials as immunotherapy in hematological malignancies and being reviewed by the FDA for approval. This report from China represents the first application of CRISPR in a human to delete immune checkpoint function and could yield greater and longer term immunotherapy, but also could leave the patient with a permanent auto immune syndrome, or worse, some new and unpredicted phenotype of the immune cell, including malignant transformation. Of course, we will not advance the medical field without taking risks - so the question is not whether to move forward or not, it is a matter of when. Have we carefully maximized the safety, monitoring plan and informed consent process in passing through this new boundary?

quotes

Reply

Jeff Patton, M.D. (Posted: November 15, 2016)

quotes

Good for Genentech! The abuse of this program needs to end ASAP. I agree with the author and hope that the new administration will take a close look at this program and bring it back to the initial and laudable intent and away from current abuses.

quotes