Study Finds Benefits With Avastin For Aggressive Breast Cancer

A group of Italian researchers indicate that the controversial cancer drug Avastin may yet play a role in the treatment of some forms of breast cancer, despite the FDA’s recent decision to revoke the drug’s approval for treatment of breast cancer. 

According to findings expected to be presented this week at the Breast Cancer Symposium in San Antonio, Texas, Avastin appears to prolong the life of women with HER2-positive breast cancer when used with other drugs.

The study was funded by Genentech, a Roche subsidiary and the maker of Avastin, and was conducted by researchers from the San Raffaele Cancer Center in Milan, Italy. 

Last month the FDA withdrew Avastin’s breast cancer approval, saying that the drug’s health risks outweighed its benefits to women with breast cancer. The revocation of the breast cancer approval means that the Genentech can no longer promote Avastin for the treatment of breast cancer, even though doctors can still prescribe it “off-label” for such use. However, the revocation also means that insurance companies are not obliged to pay for the drug, which can cost nearly $88,000 per year.

The new study looked at 216 patients taking Avastin along with the chemotherapy drugs Herceptin and docetaxel and compared them with 208 patients taking chemotherapy drugs alone. The findings indicate that women taking Avastin with chemotherapy drugs to treat HER2-positive breast cancer lived three months longer than those that did not.

HER2-positive is considered a more aggressive form of breast cancer that is often more difficult to treat.

Avastin (bevacizumab) was approved by the FDA in 2004 for treatment of non-small cell lung cancer and colorectal cancer when combined with chemotherapy. It was then was granted accelerated approval for use with paclitaxel to treat breast cancer patients by FDA in February 2008. The drug prevents the formation of new blood vessels in tumors, starving them and inhibiting their growth.

The approval of Avastin for breast cancer treatment was based on a clinical trial finding that it slowed the growth of breast cancer tumors, at odds with the usual requirement that breast cancer treatment drugs show that they actually extend the lives of patients. As part of the accelerated approval process, Genentech, a subsidiary of Roche, had to continue two more drug trials and then submit their findings to FDA.

FDA drug safety investigators say that those studies have failed to show that Avastin prolongs the life of breast cancer patients or improves their quality of life, despite a large number of anecdotal stories from breast cancer patients that used and believe in the drug.

In addition to failing to show any actual benefits, Avastin side effects can include severe high blood pressure, bleeding, hemorrhaging, heart attacks, heart failure and the drug has also been linked to the development of perforations in the nose, intestines and stomach.