Robert Burger, MD, Director, Women’s Cancer Center at Fox Chase Cancer Center
Some of you have probably read that an advisory committee (ODAC) to the U.S. FDA voted 12 to 1 against full approval of the drug Avastin in the treatment of advanced and metastatic breast cancer. Avastin, in combination with chemotherapy, is fully approved by the FDA for the treatment of other cancer types, such as metastatic colorectal cancer and advanced non-small cell lung cancer. We are privileged to have Dr. Massimo Cristofanilli, Chair of the Department of Medical Oncology and world renowned expert on this disease, discuss the reasons for this decision as well as the ramifications to patients in the future. He will address the potential impact on treatment options and research related to Avastin and other targeted therapies directed against the process of tumor angiogenesis. We welcome your comments and questions.
Be well,
Bob
The options and effectiveness of treatments for advanced breast cancer have increased significantly over the last few decades, and with it, dramatic improvement in overall survival. The 5-year survival rate for patients diagnosed from 1974-1979 was 10 percent, and has improved for patients diagnosed 1995-2000 to 44 percent. The numbers are even better today.
Oncologists are making this progress through the development and use of biological agents and chemotherapy – one of the major breakthroughs in breast cancer care – and researchers have designed even more treatments that improve patient quality of life.
Some Fox Chase patients have been prescribed Avastin to treat either advanced (metastatic), breast cancer or ovarian cancer. Developed by the Genentech unit of Roche, Avastin demonstrated an ability to significantly delay tumor progression in patients with advanced breast cancer, when combined with a variety of chemotherapy regimens.
Last week, follow-up data failed to show an advantage in survival for breast cancer patients using Avastin, and based on this data, an advisory panel to the Food and Drug Administration (FDA) has recommended the discontinued use of Avastin as a treatment option for breast cancer.
While this announcement could mean the FDA will decide to revoke approval for Avastin’s use in breast cancer care on September 17, 2010, it is important to understand this is only the first step in an involved process. Avastin has shown promise and value to some patients but may not be appropriate for broader use specific to breast cancer: All of these facets will be discussed and weighed in the coming weeks. Until the FDA makes its ruling in September, Avastin is available and a viable treatment option for those with metastatic breast cancer.
Avastin is also being explored by doctors, including our own Dr. Burger, as an effective treatment option for advanced ovarian cancer. While research is still developing, Dr. Burger presented some very encouraging clinical trial results last month at the annual meeting for the American Society of Clinical Oncologists (ASCO).
If you are confused about any of the information you are reading in the news regarding Avastin or other cancer therapies, I encourage you to comment here or consult your doctor as to what is available and best for you.
Thank you,
Massimo Cristofanilli, M. D., F. A.C. P.
Professor and Chairman, Department of Medical Oncology
G. Morris Dorrance Jr. Endowed Chair in Medical Oncology
1 Comment to 'FDA Ruling Not the Final Word on Avastin and Metastatic Breast Cancer'
You know how they say, you have to to trust your doctors right? Well, from the moment I became a patient at Fox Chase, I have had complete faith in the doctors at Fox Chase Cancer Center. I hear and read so many wonderful things about what they do for people, and I know what they have done for me. My reaction is that if they feel that this drug can be used in conjunction with other drugs to effectively help breast cancer patients (and ovarian cancer patients), then I would believe them–I wouldn’t think that the drug could do any harm right? Can Dr. Christofinilli or Dr. Burger have a crack at presenting their evidence to the FDA instead of just at the ASCO? How does that work? The FDA may not approve this drug alone as a breast cancer therapy, but would that mean that the doctors could not use this drug at all for this purpose along with other therapies? As a cancer patient, I must comment that I would do whatever it takes to be rid of this awful disease. I did note that they do use Avastin to treat other cancers. I would be interested to hear the outcome.




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winter, summer is finally here and off to a warm start. I know that many of you are taking advantage of the sun by going to the beach, working in your garden, or just spending more time outside. But are you protecting your skin while enjoying these activities? This is an important question, since a recent survey by the American Academy of Dermatology found that only 35 percent of people surveyed were aware that any type of ultraviolet rays are unsafe for your skin, and that skin cancer is the most common of all cancers. 






