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More Evidence Cancer Drug Avastin May Cause Harm
Date:2/2/2011

By Amanda Gardner
HealthDay Reporter

TUESDAY, Feb. 1 (HealthDay News) -- A new review finds more evidence that the beleaguered cancer drug Avastin may harm patients.

An analysis of previously published studies found that the drug, when used in combination with chemotherapy or biological therapy, actually increased patient deaths from adverse events, compared with using chemotherapy or biologics alone.

This new information should change the way patients and practitioners think about the drug, said Dr. Shenhong Wu, senior author of the report, published Feb. 2 in the Journal of the American Medical Association.

"I believe the risk-benefit ratio has changed," said Wu, assistant professor of medicine at Stony Brook University Medical Center in Stony Brook, N.Y. "Physicians need to think about this."

Avastin (bevacizumab) was okayed in 2008 for use in conjunction with chemotherapy to treat breast cancer under the U.S. Food and Drug Administration's accelerated approval program. Approval was based on one clinical trial in patients with metastatic HER2-negative breast cancer that found a benefit in terms of cancer recurrence -- but not overall survival -- and was contingent on further data to confirm the results.

Three subsequent studies failed to find an overall survival benefit and, in fact, showed less impressive improvements in survival involving no progression of cancer.

After reviewing all four studies, the FDA in December recommended revoking approval of Avastin to fight breast cancer. The recommendation didn't affect use of Avastin for advanced colon, lung, kidney and brain cancer.

Wu and his colleagues looked at 16 completed randomized controlled trials on Avastin involving more than 10,000 patients with different forms of cancer.

Some 2.5 percent of patients taking Genentech-made Avastin died compared with 1.7 percent of those taking chemotherapy alone, a 46 perce
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