You can’t get past the month of October without knowing that it’s dominated by all things breast cancer (officially, it’s National Breast Cancer Awareness Month). Instead of screening this year, the big news seemed to revolve around genetic testing, in particular the BRCA1 and BRCA2 gene mutations. Here’s a sampling of breast cancer news from 2013:
1) The best news this year for women with breast cancer
The FDA approved two new treatment options. There’s a chance that treating women at high risk for the disease earlier may make it less deadly—possibly shrinking tumors or delaying or preventing a recurrence. That’s the idea behind Perjeta® (pertuzumab), the first FDA-approved drug for use in breast cancer pre-surgery (approved Sept. 30th). It’s intended for women with HER2-positive, early-stage breast cancer for whom there’s a good chance of the cancer recurring, spreading or being lethal. Clinicians have called the therapy “game-changing.” U.S. regulators also approved Kadcyla® (ado-trastuzumab emtansine), a follow up to Herceptin® (trastuzumab), indicated for patients with HER2-positive, late-stage breast cancer who have not responded to other therapies. Kadcyla is the only FDA-approved antibody-drug conjugate (ADC) for a solid tumor (approved Feb. 22nd) and it delivers a powerful punch to kill cancerous cells. Both drugs were developed by Roche/Genentech.
2) Genetic testing, radical options
Actress Angelina Jolie’s disclosure in May that she had chosen to have a preventive double mastectomy after genetic testing showed that she carried the BRCA1 gene mutation, which placed her at an 80 to 90% risk for developing breast and ovarian cancer, did a lot to further the dialogue about breast cancer risks and women’s choices in 2013. The media subsequently reported a run on genetic testing by women—and on average American women at risk for breast cancer opting to having one or both breasts removed rather than having to face a future cancer diagnosis or a recurrence. The American Cancer Society urged caution for women considering more radical options like Jolie. In January, months before Jolie’s announcement, double mastectomies were reported to be on the rise, both among women with cancer in only one breast and for women at genetic risk who hadn’t yet been diagnosed. Maybe Jolie’s much-publicized decision wasn’t so much a driving force for women facing the same dilemma as it was just a part of a trend already in progress?
3) Historic SCOTUS decision
Some positive news in June on genetic testing: The Supreme Court issued a landmark ruling and said that human genes such as BRCA1 and BRCA2 could not be patented, putting a crimp in Myriad Genetics’ long-held monopoly on testing for those genes. The SCOTUS ruling finally opened up the marketplace to some real competition and that decision is already showing progress in making BRCA genetic testing not only cheaper, but more widely available to many more women. Quest Diagnostics is already offering their BRCAvantage tests nationwide, at a cost of about $2,500, well below Myriad’s tab of $3,000 to $4,000. Other smaller companies have also jumped on the bandwagon.
4) Redefining premalignant cancers
Strike the word “carcinoma” from the lexicon for premalignant conditions, a group of experts to the National Cancer Institute (NCI) advised in July. The suggestion included renaming the precancerous breast condition known as “ductal carcinoma in situ (D.C.I.S.).” Changing the terminology might reduce the needless overdiagnosis and overtreatment that many women experience and also lessen the fear factor that words like carcinoma invite. But Dr. Larry Norton, deputy physician-in-chief of breast cancer programs at Memorial Sloan-Kettering, pointed out one of the issues inherent in a discussion on changing cancer’s terminology and its more indolent forms: “Which cases of D.C.I.S. will turn into an aggressive cancer and which ones won’t?,” he asked in a New York Times article.
5) Anti-estrogen drugs as prevention
The U.S. Preventive Services Task Force (USPSTF) in September issued final guidelines recommending that doctors offer tamoxifen and raloxifene, two medications which block estrogen in the breast tissue, as an option to healthy women who are at an increased risk of breast cancer. Data presented at ASCO showed that, for women who’d already had breast cancer, taking tamoxifen for ten years instead of the recommended five made the disease less likely to recur. In spite of adverse side effects, including blood clots and strokes, the benefits of taking the anti-estrogen drugs were found to outweigh the risks for women at risk for developing breast cancer. For women who can’t or don’t want to take these two medications, plenty of other non-pharmaceutical ways to reduce breast cancer risk were also on the radar this year, including simply walking.
6) New HER2 guidelines
Recently an updated guideline was jointly issued by ASCO and the College of American Pathologists (CAP) recommending that all women with invasive breast cancer should be tested for the HER2 gene and protein. The guideline is meant to better standardize testing and ensure that women with HER2-positive cancers receive HER2-targeted therapies which can substantially improve these patients’ survival. Likewise, the guideline said that HER2-negative women should only be treated with therapies appropriate to their particular subtype of cancer in order to avoid the side effects and costs associated with the HER2-targeted drugs.
And just for the record, as of 2013 physicians now have four FDA-approved HER2-targeted therapies to choose from for their patients: Kadcyla (2013), Perjeta (2012), Tykerb® (lapatinib) (2007) and Herceptin® (trastuzumab) (1998).
By Nancy Ciancaglini, OBR Daily Managing Editor
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