FDA Rejects Clinical Trial Data of Avastin

Fran Visco Health Guide
  • Last month, amid the holiday rush and year-end preparations, the fight against breast cancer continued. A week before Christmas, many of us from NBCC -- Executive Vice President Carolina Hinestrosa, other staff, and advocates from around the country -- traveled to San Antonio for the 30th Annual San Antonio Breast Cancer Symposium. This meeting is touted as the largest gathering of scientists in the breast cancer research field. Doctors, researchers, advocates and health care professionals from across the country and around the globe met to share state-of-the-art breast cancer information including briefings on ongoing and soon-to-be released studies, important new research findings, lectures by experts, and much more. You could call it the "Super Bowl" of breast cancer research.

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    That is why it was so important for all of us to have been there - to spend time learning about the latest developments and cutting-edge updates and giving a trained advocate perspective on all the issues. We had the opportunity to exchange views on the hottest research topics of the day with experts, attend and participate in panels and sessions, and engage the leading minds in the field of breast cancer research in meaningful and thought-provoking discussions. It is yet another way for breast cancer activists to make themselves part of the research process.


    As the most evidence-based of the advocacy organizations, NBCC had a particular responsibility at the San Antonio Breast Cancer Symposium. Our science training programs (Project LEAD®, Quality Care Project LEAD®, Clinical Trials Project LEAD®) equip advocates to understand, question and in some cases challenge what is being presented at these meetings. As the "gold standard" for grassroots breast cancer organizations, it is our duty to be fully involved in events like the San Antonio Breast Cancer Symposium that are so central in moving breast cancer research forward.


    In fact, NBCC ran a session of its own, covering several subjects from the consumer advocate perspective. We look at what is important to patients, to the public at large, and what we see as the issues needing debate. For example, at our session, erythropoiesis stimulating agents (ESAs), which are used to stimulate the production of red blood cells to reverse anemia caused by chemotherapy, were discussed; as well as anthracyclines, which are widely used in combination chemotherapies to prevent the spread of breast cancer.


    Discussions about these two forms of treatment are important because they are in widespread use in breast cancer yet data are accumulating regarding their limited value at the cost of serious side effects. The item in our session provoking the most audience interest was a new drug for breast cancer, bevacizumab (Avastin) - an innovative therapy designed to inhibit tumor growth by stopping the formation of new blood vessels needed to nourish the tumor - in effect "starving" the tumor.


    This idea has been around for quite a while, and despite spectacular cures of mice in the laboratory, results in humans are unclear and seemingly quite modest. Clinical trials have been conducted to see if it will work in breast cancer. The results of two of those Avastin trials were recently presented to the Oncology Drug Advisory Committee (ODAC) of the Food and Drug Administration. ODAC decided against recommending bevacizumab for approval, because data from the clinical trials did not demonstrate that this treatment prolongs the lives of women with advanced breast cancer beyond current treatments.


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    In fact, there were more deaths and serious side effects in the treatment group that included bevacizumab. Another issue discussed among participants at our San Antonio session was the high cost of newer cancer therapies including bevacizumab. It was a timely discussion, considering the FDA is slated to make a final decision on bevacizumab in February.


    These gatherings offer a snapshot of what is going on in the breast cancer research community. Ideas are born and connections are made. As I have said before, all the money in the world will not eradicate breast cancer if it is spent on the wrong research. The San Antonio Breast Cancer Symposium does not tell us how close we are to ending breast cancer. But it can at least show us where we are, and shed a light on where we might want to go.

Published On: January 07, 2008