Effect of Amifostine on Response Rates in Locally Advanced Non–Small-Cell Lung Cancer Patients Treated on Randomized Controlled Trials: A Meta-Analysis

Purpose Amifostine can reduce the cytotoxic effects of chemotherapy and radiotherapy in patients with locally advanced non–small-cell lung cancer, but concerns remain regarding its possible tumor-protective effects. Studies with sufficient statistical power to address this question are lacking. Methods and Materials We performed a meta-analysis of all published clinical trials involving locally advanced non–small-cell lung cancer patients treated with radiotherapy with or without chemotherapy, who had been randomized to treatment with amifostine vs. no amifostine or placebo. Random effects estimates of the relative risk of overall, partial, and complete response were obtained. Results Seven randomized trials involving 601 patients were identified. Response rate data were available for six studies (552 patients). The pooled relative risk (RR) estimate was 1.07 (95% confidence interval, 0.97–1.18; p = 0.18), 1.21 (95% confidence interval, 0.83–1.78; p = 0.33), and 0.99 (95% confidence interval, 0.78–1.26; p = 0.95) for overall, complete, and partial response, respectively (a RR >1 indicates improvement in response with amifostine compared with the control arm). The results were similar after sensitivity analyses. No evidence was found of treatment effect heterogeneity across the studies. Conclusions Amifostine has no effect on tumor response in patients with locally advanced non–small-cell lung cancer treated with radiotherapy with or without chemotherapy.