Localized chemotherapy (carmustine wafer)

In a multicenter, randomized, placebo-controlled trial, 222 patients with recurrent malignant primary brain tumors requiring reoperation were randomly assigned to receive implanted carmustine wafers or placebo biodegradable wafers.[1][Level of evidence A1] Approximately one-half of the patients had received previous systemic chemotherapy. The two treatment groups were well balanced at baseline.

In a multicenter, randomized, placebo-controlled trial, 222 patients with recurrent malignant primary brain tumors requiring reoperation were randomly assigned to receive implanted carmustine wafers or placebo biodegradable wafers.[1][Level of evidence A1] Approximately one-half of the patients had received previous systemic chemotherapy. The two treatment groups were well balanced at baseline.

Median survival was 31 weeks in the group receiving carmustine wafers versus 23 weeks in the group receiving placebo wafers. The statistical significance between the two overall survival curves depended on the method of analysis.

In a multicenter, randomized, placebo-controlled trial, 222 patients with recurrent malignant primary brain tumors requiring reoperation were randomly assigned to receive implanted carmustine wafers or placebo biodegradable wafers.[1][Level of evidence A1] Approximately one-half of the patients had received previous systemic chemotherapy. The two treatment groups were well balanced at baseline.

The hazard ratio (HR) for risk of dying in the direct intention-to-treat comparison between the two groups was 0.83 (95% confidence interval [CI], 0.63–1.10; P = .19). The baseline characteristics were similar in the two groups, but the investigators performed an additional analysis, adjusting for prognostic factors, because they felt that even small differences in baseline characteristics could have a powerful influence on outcomes. In the adjusted proportional hazards model, the HR for risk of death was 0.67 (95% CI, 0.51–0.90; P = .006). The investigators emphasized this latter analysis and reported this as a positive trial.[1][Level of evidence A1]

A Cochrane Collaboration systematic review of chemotherapeutic wafers for high-grade glioma focused on the unadjusted analysis and reported the same trial as negative.[2]