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著者: Manfred Westphal, Dana C Hilt, Enoch Bortey, Patrick Delavault, Robert Olivares, Peter C Warnke, Ian R Whittle, Juha Jääskeläinen, Zvi Ram
雑誌名: Neuro Oncol. 2003 Apr;5(2):79-88. doi: 10.1093/neuonc/5.2.79.
Abstract/Text
A previous placebo-controlled trial has shown that biodegradable 1,3-bis (2-chloroethyl)-1-nitrosourea (BCNU) wafers (Gliadel wafers) prolong survival in patients with recurrent glioblastoma multiforme. A previously completed phase 3 trial, also placebo controlled, in 32 patients with newly diagnosed malignant glioma also demonstrated a survival benefit in those patients treated with BCNU wafers. Because of the small number of patients in that trial, a larger phase 3 trial was performed to confirm these results. Two hundred forty patients were randomized to receive either BCNU or placebo wafers at the time of primary surgical resection; both groups were treated with external beam radiation postoperatively. The two groups were similar for age, sex, Karnofsky performance status (KPS), and tumor histology. Median survival in the intent-to-treat group was 13.9 months for the BCNU wafer-treated group and 11.6 months for the placebo-treated group (log-rank P -value stratified by country = 0.03), with a 29% reduction in the risk of death in the treatment group. When adjusted for factors affecting survival, the treatment effect remained positive with a risk reduction of 28% ( P = 0.03). Time to decline in KPS and in 10/11 neuroperformance measures was statistically significantly prolonged in the BCNU wafer-treated group ( P
PMID 12672279 Neuro Oncol. 2003 Apr;5(2):79-88. doi: 10.1093/neuonc/5.2.79.
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