Roche Holding ADRs Down 1.6% as Avastin Annual Forecast Cut
Avastin Boosted Survival for Type of Aggressive Breast Cancer
Added to chemo treatment, the drug prolonged life an average of nearly 3 months, researchers say.
By Randy Dotinga, HealthDay News
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WEDNESDAY, Dec. 7, 2011 (HealthDay News) —In November, the U.S. Food and Drug Administration revoked its approval of the drug Avastin for the treatment of breast cancer. But, a new study suggests that the drug can boost the survival of women with a specific type of aggressive breast tumor when used in conjunction with two other medications.
Avastin (bevacizumab) had been approved in the United States in 2008 as a treatment for metastatic breast cancer — cancer that has spread to other parts of the body. It was used with chemotherapy to treat a type of breast tumor called HER2-negative.
Even though the FDA withdrew that approval, Avastin is still approved to treat some other types of cancers. Doctors may legally prescribe the drug to treat breast cancer, although insurers may refuse to cover it.
According to the FDA, the benefits of Avastin use for breast cancer do not justify the risks, which may include severe high blood pressure, bleeding, and heart attack or heart failure.
The new study was funded by Genentech, which makes Avastin, and led by Dr. Luca Gianni, director of medical oncology at the San Raffaele Cancer Center in Milan, Italy. They examined the use of the drug as a treatment for HER2-positivebreast cancer that had recurred locally in the body or spread to other parts of the body. HER2-positive breast cancers are typically less sensitive to standard hormonal treatments and are often more aggressive than other types.
A total of 216 patients received Avastin with a chemotherapy treatment of trastuzumab (Herceptin) and docetaxel, while 208 received the chemotherapy alone.
An investigator and an expert review committee disagreed about how much of a difference the drug made in the risk of cancer progression or death. But overall, according to investigator and independent review committee analysis, the addition of the Avastin boosted the average months of survival (without worsening of the cancer) by nearly three months, the researchers said.
Dr. Hannah M. Linden, an oncologist and associate professor of medicine at the University of Washington in Seattle, called the research "exciting."
"I am delighted that further analysis will be done to try to determine which tumors respond to each therapy, and really which tumors donotneed extra treatment," Linden said. "With HER 2-positive tumors, we have a plethora of options and need to learn to be efficient in maximizing benefit to patients and minimizing toxicity."
The study is scheduled for presentation this week at the 2011 San Antonio Breast Cancer Symposium. The data and conclusions of research presented at medical meetings should be viewed as preliminary until published in a peer-reviewed journal.
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