INTERSTITIAL CHEMOTHERAPY WITH CARMUSTINE-LOADED POLYMERS FOR HIGH-GRADE GLIOMAS - A RANDOMIZED DOUBLE-BLIND-STUDY

OBJECTIVE: To find out the effect of carmustine (bischloroethyl-nitros ourea) combined with a biodegradable polymer in the treatment of malig nant (Grades III and IV) gliomas, applied locally, at the time of the primary operation. METHODS: Prospective, randomized double-blind study of an active treatment group versus a placebo group. Conducted at the Departments of Neurosurgery of the University Hospitals of Helsinki, Tampere, and Turku in Finland and Trondheim in Norway. The study consi sted of 32 patients (16 in each treatment group) enrolled between Marc h 23, 1992, and March 19, 1993. The study was planned to include 100 p atients but had to be terminated prematurely, because the drug that wa s being used had become unobtainable. The main outcome measures includ ed the survival times of patients after the operations and the applica tion of an active drug or placebo. RESULTS: The median time from surge ry to death was 58.1 weeks for the active treatment group versus 39.9 weeks for the placebo group (P = 0.012). For 27 patients with Grade IV tumors, the corresponding times were 39.9 weeks for the placebo group and 53.3 weeks for the active treatment group (P = 0.008). At the end of the study, six patients were still alive, five of whom belonged to the active treatment group. CONCLUSION: Carmustine applied locally in a biodegradable polymer at the time of primary operation, seems to ha ve a favorable effect on the life span of patients with high-grade gli omas.