Breast Cancer Patients Face Risk of Avastin Heart Problems: Study

The findings of a new study linking Avastin to heart failure, appear to back up the FDA’s recent decision to withdraw approval for the drug to be used for treatment of breast cancer. 

A meta-analysis published online in the Journal of Clinical Oncology on January 4, found that breast cancer patients who were given Avastin faced an increased risk of heart failure. Researchers from the Dana-Farber Cancer Institute in Boston said that patients in the study often started out with healthy hearts before being given Avastin.

The meta-analysis looked at 3,784 breast cancer patients using databases from 1966 to March 2010. About 1.6 percent of patients who were given Avastin developed heart failure; five times the number of heart failures compared to patients given a placebo. Dosage did not appear to make a difference in the rate of heart failure and was consistent among patients who received both high and low doses. There was also no change depending on the chemotherapy regimen the patients were being given.

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 by the FDA in February 2008, for use with paclitaxel to treat breast cancer. The drug prevents the formation of new blood vessels in tumors, starving them and inhibiting their growth.

The study comes less than a month after the FDA announced that it was revoking Avastin’s approval for the treatment of breast cancer. That decision came after an FDA review which determined that Avastin did little to help breast cancer patients and increased the risks of severe high blood pressure, heart attack, heart failure, bleeding and hemorrhaging, and the development of perforations in the nose, stomach and intestines.

The FDA’s decision to revoke approval for breast cancer treatment did not result in an Avastin recall, as the medication remains approved for other uses. Therefore, doctors may still be prescribing Avastin off-label for breast cancer patients.

Some women have said that Avastin has worked well on their breast cancer, but the FDA said that it must rely on the clinical trials and not anecdotal evidence. FDA officials said that there could be any number of reasons some women have seen significant cancer benefits while on Avastin that are not linked to the drug’s effectiveness.