TUESDAY, Feb. 1 (HealthDay News) -- A new review finds more
evidence that the beleaguered cancer drug Avastin may harm
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
percent increased risk, the investigators found.
The rate was about the same across tumor types but not across
different chemotherapy regimens. The risk was increased among those
receiving chemotherapy containing taxanes or platinum agents but
not other chemo compounds.
The most common causes of death were hemorrhage, followed by low
white-blood-cell count and gastrointestinal perforations.
Dr. Roman Perez-Soler, chairman of oncology and chief of medical
oncology at Montefiore Medical Center in New York City, a lung
cancer expert, pointed out that lung cancer is one of the few
malignancies in which Avastin has prolonged survival and thus might
still have a place in this armamentarium.
But an accompanying journal editorial raises other
considerations, including the cost ($50,000 a year for the drug
alone, plus the cost of monitoring and chemo) and a cumbersome
delivery method (frequent injections for years).
The author of that editorial acknowledged that Avastin works
well in some patients, but said it's impossible to predict in which
patients and for how long benefits will last.
The U.S. National Library of Medicine has more on
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