Last year, the advisory committee to the FDA voted to advise approval of a cancer drug, Perjeta, that could be used to treat breast cancer patients before surgery. Now, a new clinical trial sponsored by Swiss drug maker Roche, found that patients taking this same drug used in combination with Herceptin lived about 16 months longer on average than those patients in the control group.
The trial included about 800 patients with HER2-positive metastatic breast cancer, meaning the cancer has spread to other parts of the body. HER2-positive breast cancer is characterized by an abundance of the protein HER2 and accounts for about 20 percent of breast cancers. Half the study patients received Perjeta, Herceptin, and the chemotherapy drug docetaxel, while the other half received Herceptin, docetaxel, and a placebo. Average survival time for those in the Perjeta group was 56 months compared with about 41 months for those in the control group. Side effects included higher rates of diarrhea and rash and the lowering of white blood cell counts in the Perjeta group, but higher rates of cardiac dysfunction and heart failure were not seen in these patients.
Lead author of the study, Dr. Sandra M. Swain of the MedStar Washington Hospital Center says, We ve never seen anything like this before. It s really unprecedented to have this survival benefit. Most cancer drugs used to treat metastatic cancer prolong life for only a few months.
Currently, only about half of the cancer patients who are eligible to receive Perjeta are using it. And in some countries where cost is an issue, that number may be even lower.
