Avastin survival data mixed in breast cancer
NEW YORK (Reuters Health) - In women with advanced breast cancer, progression-free survival (that is, a patient remaining alive without the disease getting worse) is improved with the addition of Avastin to the commonly-used drug paclitaxel, but overall survival is not affected, according to a study reported in The New England Journal of Medicine this week.
Known generically as bevacizumab, Avastin is a monoclonal antibody that binds to endothelial growth factor (VEGF), which in turn inhibits the formation of new blood vessels, cutting off oxygen and nutrients cancer cells need to survive.
Dr. Kathy Miller, from Indiana University Cancer Center in Indianapolis, and colleagues assessed the outcomes of 722 women with metastatic breast cancer who were randomized to receive paclitaxel alone or in combination with Avastin. Paclitaxel was given on days 1, 8, and 15 every 4 weeks, while Avastin was given on days 1 and 15.
The median progression-free survival period with the drug combination was 11.8 months, twice as long as the 5.9 months achieved with paclitaxel alone. The objective response rate was also higher when both drugs were given: 37 percent versus 21 percent.
As noted, however, no significant difference in overall survival was seen between the groups, with a median survival period for each of about 26 months.
High blood pressure, blood clots, heart attacks, and infection were seen more often in the combination arm than the single-drug arm.
In early December, a U.S. advisory panel recommended against approval of Avastin to treat women with breast cancer. The panel decided by a vote of 5-4 that Avastin maker Genentech Inc failed to establish a favorable balance of risks and benefits in the data it presented for Avastin's use in advanced breast cancer patients.
Avastin currently is approved by the U.S. Food and Drug Administration (FDA) for treating lung and colon cancer, but many doctors use it to treat breast cancer.
SOURCE: The New England Journal of Medicine, December 27, 2007.
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Avastin survival data mixed in breast cancer
Avastin (chemical name: bevacizumab) is a targeted therapy medicine approved by the U.S. Food and Drug Administration (FDA) to treat advanced cancers of the lung, colon, and rectum. Avastin has been studied in combination with chemotherapy medicines such as Taxol (chemical name: paclitaxel) and Xeloda (chemical name: capecitabine) to treat advanced breast cancer.The study reviewed here found that when women diagnosed with advanced breast cancer got both Avastin and Taxol they had more time before the cancer got worse, compared to women who got only Taxol. Still, the combination of Avastin and Taxol didn't improve overall survival.
This could be because the benefits of adding Avastin to Taxol are too small to affect the overall survival of women with advanced breast cancer. It also could be that Avastin's benefits came with side effects, including some that are life-threatening, so overall survival did not improve.
Avastin has a number of potentially serious side effects, including high blood pressure, nose bleeds, and extra protein in the urine. Avastin also may increase the risk of stroke and heart problems.
Recently, 5 of 9 experts on an FDA panel reviewed research on Avastin and recommended the FDA not approve Avastin to treat advanced breast cancer. The FDA hasn't made a final decision yet. The FDA doesn't have to follow the experts' advice, but it usually does so.
If you're being treated for advanced breast cancer, your doctor may still recommend Avastin as part of your treatment plan. The experts on the FDA review panel made their decision based on overall results from the clinical studies. Your doctor's recommendation will be based on information from published research and your doctor's experience with Avastin to treat other people with breast cancer, as well as YOUR unique situation.