OBR Daily Commentary

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FDA Approves New Dosing Regimen For Cetuximab

(FDA.gov) Apr 7, 2021 - On April 6, 2021, the Food and Drug Administration approved a new dosage regimen of 500 mg/m2 as a 120-minute intravenous infusion every two weeks (Q2W) for cetuximab (Erbitux, ImClone LLC) for patients with K-Ras wild-type, EGFR-expressing colorectal cancer (mCRC) or squamous cell carcinoma of the head and neck (SCCHN). This approval provides for a biweekly dosage regimen option in addition to the previously approved weekly dosage regimen for the approved indications when cetuximab is used as a single agent or in combination with chemotherapy.

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Howard S. Hochster, MD (Posted: April 07, 2021)

quotes"UPDATE": I am glad the FDA caught up with itself. The dosing regimen for Cetuximab was approved by the FDA in the ECOG E7208 trial more than a decade ago (actually in 2009). This will at least stop pharma trials from requiring patients to come in every week for a drug that can be given every 2 weeks!quotes

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A ‘Game Changer’ for Patients With Esophageal Cancer

(New York Times) Mar 31, 2021 - A drug that unleashes the immune system offers a rare glimmer of hope for those with a cancer that resists most treatments. For decades, esophageal cancer has defied scientific attempts to discover a therapy that extends patients’ survival, year after year claiming the lives of such illustrious people as Humphrey Bogart, Christopher Hitchens and Ann Richards, the former governor of Texas.

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Howard S. Hochster, MD (Posted: April 01, 2021)

quotesLEFT UNSAID: Certainly an advance in treatment of UGI cancers, this analysis leaves many questions open. Esophageal vs GEJ = 60/40 with 70% adenoca. Benefit same across all groups? And most importantly, the personalized approach with CPS scores. In the main paper this is left unsaid, using tumor PDL1 stain which is non-informative, but see Table S2 in the supplementary material. All the benefit appears to be in CPS>/= 5 (and data are not shown for CPS 0 or 1-5), which is about half the patients. Should everyone in this adjuvant situation receive 1 year of expensive and potentially toxic treatment, regardless of CPS? More analysis of these data are needed!quotes

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COVID-19 And Cancer Consortium Study Highlights Racial Disparities, Increased Mortality For Patients Facing Dual Diagnoses

(VUMC Reporter) Mar 19, 2021 - The COVID-19 and Cancer Consortium (CCC19) published new findings in the Annals of Oncology showing heightened mortality and racial disparities for patients with cancer diagnosed with SARS-CoV-2 infection. After reviewing detailed information from almost 5,000 patients with active or past cancer and laboratory-confirmed COVID-19 diagnosis, CCC19 study authors found associations among laboratory measures, clinical factors — including older age, hematological malignancy and recent chemotherapy — and poor clinical outcomes. Of the patients in the study with COVID-19 and cancer, 58% required hospitalization and 14% died within 30 days — compared with a COVID-19 death rate below 2% for the general population.

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Howard S. Hochster, MD (Posted: March 22, 2021)

quotesThis survey of nearly 5000 patients reports on outcomes of cancer patients with COVID. This study is heavily skewed toward hospitalized patients (58%), as those were the ones enrolled as compared with the many outpatients with COVID (at least in our experience at my institution and also by the apparent numbers). Even in the early months of 2020, many more cancer patients were infected and not hospitalized than requiring hospitalization. So there is a large component of selection bias and we cannot assume this represents the true universe of cancer patients infected. Nonetheless, for those who were hospitalized, those with low performance status, recent cytotoxic chemotherapy, high ANC, high CRP all had worse outcomes. The overall mortality was 14%, which is high even when taking selection bias into account. The upshot is: cancer patients, regardless of age, should be vaccinated with high priority. Too many of our patients still cannot get vaccines. State authorities, please take note!quotes

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Meet the Editorial Board

Prostate Cancer
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Tomasz M. Beer, MD, FACP

Professor of Medicine, Division of Hematology/Medical O...

Community Oncology
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Dean Gesme, MD

FACP FACPE FASCO President, Minnesota Oncology...

Breast Cancer
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Debu Tripathy, MD

Professor and Chair, Department of Breast Medical Oncol...

Lung Cancer
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H. Jack West, MD

Associate Clinical Professor, Medical Oncology Executi...

Gastrointestinal Cancers
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Howard S. Hochster, MD

Distinguished Professor of Medicine, Rutgers Robert Woo...

Radiation Oncology
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Howard Sandler, MD, MS, FASTRO

Ronald H. Bloom Chair in Cancer Therapeutics Professo...

Editor-In-Chief
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Robert A. Figlin, MD., FACP

Steven Spielberg Family Chair in Hematology Oncology P...

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Stephen M. Schleicher, M.D., MBA

Community Oncology, Medical Oncologist, OneOncology...

Health Policy
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Ted Okon

Executive Director Community Oncology Alliance...

Community Oncology
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Thomas Marsland, MD

Vice President Integrated Community Oncology Network ...

Health Policy
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William McGivney, PhD

National Health Policy Expert...