WebMD Medical News
Louise Chang, MD
Dec. 28, 2011 -- The cancer drug Avastin helped stop the spread of ovarian cancer in patients with an advanced form of the disease, two major studies have found. But it is not clear whether it helps patients to live longer than other cancer treatments.
The drug is approved in the U.S. for the treatment of advanced colorectal cancer, as well as certain brain, lung, and kidney cancers. It won approval last week in Europe to treat ovarian cancer.
In a European and Canadian study, the drug was found to delay the disease from spreading for five to six months in the highest-risk ovarian cancer patients.
In a related trial conducted in the U.S., using Avastin during chemotherapy and up to 10 months afterward was found to halt the spread of the cancer for about four additional months.
Both studies are published in the Dec. 29 issue of The New England Journal of Medicine.
Researcher Amit M. Oza, MD, who led the European study, says Avastin is the first new drug in a decade and a half to improve outcomes in ovarian cancer patients.
“This drug should certainly be considered a new standard treatment in advanced ovarian cancer, especially for women with the highest risk for recurrence,” he tells WebMD.
There was no indication in either study that patients who took Avastin lived significantly longer than those who did not, but researchers say they will continue to follow the study participants.
The lack of a clear overall survival advantage means that ovarian cancer patients in the U.S. who take Avastin will continue to do so without the FDA’s approval for the foreseeable future, says an official with the Swiss pharmaceutical company Roche, which markets Avastin.
Roche media specialist Daniel Grotzky says the company is not likely to seek FDA approval for the drug’s use in ovarian cancer patients anytime soon.
“Following initial discussions with the FDA, we do not believe the data will currently support approval,” Grotzky tells WebMD. “We are still waiting for final overall survival data to make a final decision.
Avastin does not work like conventional chemotherapy, which kills rapidly dividing cancer cells. Instead, the drug inhibits the growth of new blood vessels that feed tumors and allow them to grow -- a process known as angiogenesis.
Avastin became the first angiogenesis inhibitor available for use in the United States in 2004 for colorectal cancer.
In ovarian cancer, Avastin inhibits a protein known as vascular endothelial growth factor (VEGF), which is associated with the spread of the disease.
Not everyone is convinced that the benefits justify the additional health care dollars that will be spent if Avastin becomes a first-line treatment for advanced ovarian cancer.
In a cost analysis published last spring, Ohio State University cancer researcher David E. Cohn, MD, and colleagues concluded that the addition of Avastin to standard chemotherapy is not cost effective in these patients.
Their analysis of the U.S. study suggested that adding Avastin to chemotherapy, plus maintenance treatment with the drug, would cost more than 30 times as much as chemotherapy alone.
SOURCES:Burger, R.A. The New England Journal of Medicine, Dec. 29, 2011.Amit M. Oza, MD, Princess Margaret Cancer Center, Toronto, Canada.Daniel Grotzky, media specialist, Roche Group Communications, Basel, Switzerland.News release, University of Toronto.News release, Roche Group Media Relations.Cohn, D.E. Journal of Clinical Oncology, March 7, 2011.
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