FDA Gives Chemo-Wafers the Go-Ahead for Brain Tumors

            The FDA has just given its much-awaited OK to localized chemotherapy as a "first crack" at malignant brain tumors. The method relies on a dime-size polymer wafer-laced with the chemotherapeutic agent BCNU-that releases the drug onto malignant cells.

            "When you apply therapy directly where it's needed, you minimize whole-body side effects that would otherwise keep you from using something so potent," says Neurosurgeon in Chief Henry Brem, who developed the technique. "We've seen that quality of life improves when we can combine the implants with surgery," adds Alessandro Olivi, head of neurosurgical oncology.

             Surgeons using the Gliadel wafer first remove a tumor, then blanket the newly exposed brain surface with several of the slender disks. This area is often a "gray zone," still hiding cancer cells beyond surgery's reach. A recent Phase III study of 240 patients showed the wafers plus follow-up radiation do indeed extend life. Five times more patients cross the three-year survival mark with wafer treatment than without it.

            Gliadel technology for brain tumors has been available for some patients since 1996. But until February, the FDA had given its stamp only for recurring, highly invasive glioblastoma multiforme tumors following surgery. Now its use is expanded to all patients with primary malignant brain tumors. And, most important, patients can get the therapy when they're first diagnosed.