|"The length of time during and after treatment in which a patient is living with a disease that does not get worse. Progression-free survival may be used in a clinical study or trial to help find out how well a new treatment works."|
Monday, January 2, 2012
What is that I hear about Avastin?
Busy with holiday travel and gatherings I am just getting around to posting about the latest Bevacizumab/ Avastin ( made by Genentech ) news.
Two studies were reported in the December issue of the New England Journal of Medicine. How helpful is Avastin in treating ovarian cancer?
First, here are direct links to the NEJM previews of the articles and their conclusions ( You have to be a NEJM subscriber to read the full article) :
1873 women enrolled in the study.
Conclusion:"The use of bevacizumab during and up to 10 months after carboplatin and paclitaxel chemotherapy prolongs the median progression-free survival by about 4 months in patients with advanced epithelial ovarian cancer. (Funded by the National Cancer Institute and Genentech; ClinicalTrials.gov number, NCT00262847.)
1528 women enrolled in the study.
Conclusion: "Bevacizumab improved progression-free survival in women with ovarian cancer. The benefits with respect to both progression-free and overall survival were greater among those at high risk for disease progression. (Funded by Roche and others; ICON7 Controlled-Trials.com number, ISRCTN91273375.)
"Note: This article was an update of the Icon7 results previously reported. I heard preliminary results at the ASCO meeting in June.
Based on the authors conclusions the use of Bevacizumab improved progression free survival.
The NCI definition of progression free survival:
Let's look at the Progression Free Survival (PFS) results a bit closer. PFS for Study 1 was 10.3 months without Bevacizumab and 14.1 with Bevacizumab or an improvement of 4 months. The mean PFS for Study 2 was 22.4 months without Bevacizumab vs 24.1 months with Bevacizumab or an improvement of 1.7 months . Study 2 also looked at those women at high risk for progression and found that the PFS was 14.5 months without Bevacizumab and 18.1 months with Bevacizumab or a 3.6 month improvement. Study 2 did look at overall survival (which is harder to measure when other measures might have been taken to improve survival ).Median Overall Survival reported for Study 2 was 28.8 months without Bevacizumab and 36.6 months for the Bevacizumab group or 7.8 months.
When looking at these survival results one must keep in mind the side effects from the use of Bevacizumab. Study 1 reported more hypertension and gastro-intestinal perforations in the Bevacizumab group than the control. Study 2 reported the Bevacizumab group had "more toxic effects" than the control group.
For me the question is whether or not the 2-4 month progression free survival is worth the increased toxic side effects? I won't even think about cost - which is an entirely different discussion.
Here is how the media reported these studies:
An article published today Avastin Disappoints Against Ovarian Cancer provided this information:
"The Genentech drug won approval in Europe for advanced ovarian cancer.But its maker has no immediate plans to seek the same approval in the United States. After talking with the Food and Drug Administration, "we do not believe the data will support approval" although no final decision has been made, said Charlotte Arnold, a spokeswoman for Genentech, part of the Swiss company Roche. "
To me the results of these ovarian cancer studies resemble the recently reported breast cancer studies and the FDA probably would not approve Avastin for ovarian cancer. I know women who have been taking Avastin for a long period of time and others who were on Avastin trials. When I recurred in 2008 I was offered a trial which included Avastin and I chose to not enter the trial so that I would be guaranteed surgery then chemo. I wonder how I would feel reading these results if I had chosen Avastin and felt that it is what has kept me in remission for 2+ years? If you are a survivor how do you feel about the results?
Avastin will continue to be approved for metastatic colorectal cancer, advanced non-squamous small cell lung cancer , metastatic kidney cancer and glioblastoma.
Every Day is a Blessing!