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Avastin Shows No Benefit Against Early Stage Colon Cancer

ByABC News
May 30, 2009, 6:02 PM

June 2 -- SATURDAY, May 30 (HealthDay News) -- The cancer drug Avastin, widely used for lung, breast and metastatic colorectal cancers, appears ineffective for patients with early stage colon cancer, a result the trial's lead author called "disappointing."

"There's no sense of building up a false sense of anticipation and drama. We failed to provide patients with a novel intervention which would increase the cure rate," said that author, Dr. Norman Wolmark, chairman of the department of human oncology at Allegheny General Hospital in Pittsburgh and chairman of the National Surgical Adjuvant Breast and Bowel Project (NSABP), which conducted the study.

But at a news conference, held Saturday at the annual meeting of the American Society of Clinical Oncology (ASCO) in Orlando, Fla., Wolmark pressed the point that Avastin (bevacizumab) did bring an improvement while it was given to patients. However, this benefit vanished once patients stopped taking the drug.

"The hoped-for endpoints of the trial -- to increase the cure rate of early stage colon cancer -- were simply not met," he said. "Having said that, it is clear that there was a statistically significant transient benefit in disease-free survival during the time that [Avastin] was given, so it was effective. But, that efficacy disappeared after the year that it was given."

At one year, there was an absolute difference in disease-free survival of only 3.6 percent in favor of Avastin. And the jury may still be out on whether or not Avastin's benefits might last if patients receive it for a longer period of time. "Clearly, strong consideration should be given to clinical trials that use [Avastin] for periods of time beyond the one year that was used in this protocol," Wolmark said.

The trial, a large one involving 2,710 patients from 245 institutions, was funded by the U.S. National Cancer Institute. Drug makers Genentech and Sanofi-Aventis provided the treatment drug; Wolmark has consulted for Genentech.

Participants were randomly chosen to receive either standard chemotherapy for six months, or chemotherapy for the same period of time plus Avastin. Some patients then went on to receive six more months of Avastin.