Avastin and Breast Cancer
Posted 5/8/2011
Posted in
There has been a great deal written about the use of avastin for breast cancer. As most of you likely know, the FDA withdrew its approval of this drug (for breast cancer; it is till "on label" for some other cancers), and there has been raging controversy ever since. The data seemed pretty clear that, over a large population, it causes more harm than good--and at great cost. There are, however, some women who clearly benefit from its use, and we don't yet know how to identify who they are.
Here is a good summary from MedScape; I give you the introduction and then a link:
From Medscape Hematology-Oncology Bevacizumab Options in Breast Cancer: What to Do Now? Linda Brookes, MSc
Posted: 05/05/2011
Editor's Note: Medscape spoke with medical oncologists about the implications of the FDA's decision in December to begin withdrawing the breast cancer indication for bevacizumab.
The FDA's Decision: Yes, No
The announcement by the US Food and Drug Administration (FDA) in December 2010 that it would begin withdrawing the breast cancer indication for bevacizumab (Avastin, Genentech, Inc.)[1,2] was met with widespread speculation in print and online media about the implications of such an action for patients.
Janet Woodcock, MD, Director of the FDA's Center for Drug Evaluation and Research, stressed that the decision to withdraw the indication would not have an immediate impact on the use of bevacizumab to treat breast cancer.[3] "For patients that means no disruption in treatment. Their access to Avastin will not be affected. Oncologists who are currently treating patients with Avastin in combination with chemotherapy for metastatic breast cancer should use medical judgment in deciding whether to continue treatment with the drug or explore other treatment options," Dr. Woodcock said. As reported by Medscape News, Dr. Woodcock stressed that the FDA's decision was taken "solely on the scientific risk/benefit analysis and on the best treatment options for patients," and that "cost and reimbursement were not taken into account." Despite these reassurances, reports in the national media continued to fuel fears that insurance companies might no longer fund the drug and that oncologists would consequently no longer prescribe it.
The confusion was heightened when the updated National Comprehensive Cancer Network (NCCN) breast cancer guidelines included bevacizumab plus paclitaxel among its "preferred regimens for recurrent or metastatic breast cancer."[4] Support for bevacizumab in breast cancer was also expressed in Europe, by the European Medicines Agency (EMA), which around the same time reasserted that "the benefits of Avastin in combination with paclitaxel outweigh its risks and that this combination remains a valuable treatment option for patients suffering from metastatic breast cancer."[5] However, a US meta-analysis published early in 2011 concluded that the addition of bevacizumab therapy in all cancers increased treatment-related mortality.[6]
Given the differing reports, many physicians wonder what the best treatment strategies are for their breast cancer patients already taking bevacizumab and whether the drug should be considered for treatment in new patients. Medscape spoke with 5 breast cancer specialists across the United States to ask them whether they are already considering strategies in the event of the removal of the indication and what they believe the consequences could be for patients. All were involved in clinical trials with bevacizumab and all have patients currently taking bevacizumab. Most expressed a concern, in the event that the indication is withdrawn, that insurance companies will no longer cover bevacizumab in new breast cancer patients, and funding will cease for research to identify the subsets of patients likely to receive greatest benefit from bevacizumab, which they all regard as a valuable drug in this setting.
http://www.medscape.com/viewarticle/741722
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