By Roberta Gelb - July 30, 2010
In July, I testified against the use of Avastin as a first-line treatment for metastatic breast cancer. I was representing SHARELeaders at a public meeting of the Oncology Drug Advisory Committee (ODAC), which advises the FDA on whether or not to approve drugs for cancer treatment. At the end of the meeting, ODAC voted 12 to 1 to remove Avastin for this kind of treatment. The FDA will decide in September whether or not to take their recommendation.
My testimony (below) explains why SHARELeaders supports the removal of Avastin specifically for women with Her2 negative metastatic breast cancer who had not received chemotherapy for their advanced disease. SHARELeaders is a group of Project LEAD graduates who meet monthly at SHARE to discuss controversial issues and research results.
Read the testimony and let us know what you think. Do you agree or disagree?
TESTIMONY TO ODAC
APPLICATION FOR APPROVAL OF AVASTIN
JULY 20, 2010
My name is Roberta Gelb and I am a breast cancer survivor and a member of SHARELeaders, a group of breast cancer patient advocates who are graduates of Project LEAD, the National Breast Cancer Coalition's science course for advocates. We are affiliated with SHARE, a breast and ovarian cancer support organization, and have been meeting monthly for more than 10 years to discuss research results and controversial issues. I am here representing the views of SHARELeaders**
We have seen our sisters in SHARELeaders develop advanced disease and struggle with new therapies and toxic side effects in an effort to live longer and have a decent quality of life. Last month, two of our members died of metastatic breast cancer. One of them was only 36 years old. Both were passionate advocates who used their experiences to make a difference in the lives of others.
SHARELeaders has had on-going discussions of the research results for Avastin coupled with the hope that after accelerated approval was given, rightly or wrongly, further clinical trials would show clinical benefit…overall survival or sufficient progression free survival with quality of life. This was not the case.
The general consensus of SHARELeaders is that Avastin should not be approved as first line treatment for metastatic breast cancer.
The members of SHARELeaders advanced several different lines of argument for their decision. The first is that the trials subsequent to accelerated approval failed to demonstrate a clinically meaningful benefit, that is either an improvement in overall survival or a sufficient magnitude of progression free survival together with improved quality of life. Therefore Avastin should not be approved.
Another line of argument raised by SHARELeaders, although not directly relevant to the more narrow issue at hand, is whether progression free survival should ever serve as a credible endpoint in breast cancer research. We survivor advocates strongly believe that overall survival without compromising quality of life must remain as a primary goal of research; some believe it is the only goal. We want drugs that extend our lives and not merely the length of time until progression of our disease. Overall survival as an endpoint also enables us to know what late toxicities may arise in longer term use of the drug or even after the drug is no longer being used.
While overall survival is clearly a research goal, some SHARELeaders argue that a meaningful progression free survival time frame combined with few toxic side effects and better quality of life, could be an acceptable endpoint particularly in metastatic disease.
The Avastin results failed to show either overall survival nor any clinically meaningful progression free survival; there were critical, toxic and unacceptable side effects and little quality of life data. Any risk-benefit analysis would strongly suggest that Avastin should not be approved at this time.
**This does not reflect any decision or policy of the SHARE organization but rather is limited to the result of discussions and decisions of SHARELeaders and SHARELeaders alone.
Read more about this in Andrew Pollack's article in the New York Times.
Tell us what you think -- do you agree or disagree with ODAC's decision?
Roberta is a breast cancer survivor, advocate and SHARELeader.