CLINICAL STUDIES

Simo Valtonen, M.D., Ulla Timonen, M.D., Petri Toivanen, M.Sc., Hannu Kalimo, M.D., Leena Kivipelto, M.D., Olli Heiskanen, M.D.Prof., Geirmund Unsgaard, M.D.Prof., Timo Kuurne, M.D.

Departments of Neurosurgery (SV) and Pathology (HK), Turku University Central Hospital, Turku, Finland; Department of Neurosurgery (LK, OH), Helsinki University Central Hospital, Helsinki, Finland; Department of Neurosurgery (TK), Tampere University Hospital, Tampere, Finland; Department of Neurosurgery (GU), University Hospital of Trondheim, Trondheim, Norway; and Orion Pharma (UT, PT), Espoo, Finland

OBJECTIVE: To find out the effect of carmustine (bischloroethyl-nitrosourea) combined with a biodegradable polymer in the treatment of malignant (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 consisted of 32 patients (16 in each treatment group) enrolled between March 23, 1992, and March 19, 1993. The study was planned to include 100 patients but had to be terminated prematurely, because the drug that was being used had become unobtainable. The main outcome measures included the survival times of patients after the operations and the application of an active drug or placebo.

RESULTS: The median time from surgery 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 have a favorable effect on the life span of patients with high-grade gliomas. (Neurosurgery 41:44-49, 1997)

Key words: BCNU, Biodegradable polymer, Chemotherapy, Malignant glioma

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