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Brain Cancer Drug Gets Wider Approval

The US Food and Drug Administration has approved the drug Temodar (temozolomide) for adults with glioblastoma multiforme, the deadliest and most common type of brain cancer.

The drug is given to newly diagnosed patients during and after radiation therapy. It is a pill taken every day.

The approval was based on a randomized study of 573 patients. Half were assigned to standard radiation therapy, while the rest got standard radiation plus Temodar. Those patients continued taking Temodar for up to 6 months after radiation.

Patients who took the drug lived more than 2 months longer than those who only got radiation treatments (14.6 months vs. 12.1 months). The research, led by the European Organization for Research and Treatment of Cancer, was recently published in the New England Journal of Medicine (Vol. 352, No. 10: 987-996).

Surgery and radiation are the primary treatments for glioblastoma multiforme, an especially aggressive brain tumor. According to the FDA, about 8,000 to 10,000 new cases are diagnosed in North America every year. Average survival with this cancer is only about 1 year.

Researchers have tried adding many different types of chemotherapy to glioblastoma treatment in hopes of helping patients live longer, but so far no drug has offered a significant benefit.

For this reason, the study findings represent a "landmark" in glioblastoma treatment, according to Lisa M. DeAngelis, MD, who wrote an editorial accompanying the study. She is chair of the neurology department at Memorial Sloan-Kettering Cancer Center in New York.

The dramatic results could have been due to several factors, she noted. Most of the patients were under age 70 and otherwise relatively healthy, and most had had surgery to remove at least some of the tumor. In addition, the researchers gave the Temodar both during and after radiation, a new approach which may have made the drug more effective. (The study, however, could not determine that.)

And Temodar is a different type of drug -- and less toxic -- than other chemotherapies tried in the past, DeAngelis said.

Temodar can cause low white blood cell counts, making a patient more susceptible to infections, and low blood platelet counts. Of the patients on Temodar, 16% experienced severe blood-related side effects during the course of the study. Other possible side effects include nausea, vomiting, loss of appetite, headache, constipation, and hair loss.

Temodar is manufactured by Schering-Plough. It is also approved for treating another type of brain tumor, anaplastic astrocytoma, when other treatments are no longer working.