RANDOMIZED TRIAL OF RADIATION-THERAPY (RT) PLUS DIBROMODULCITOL (DBD)VERSUS RT PLUS BCNU IN HIGH-GRADE ASTROCYTOMA

Purpose: We performed a randomized trial to compare survival distribut ions and toxicity of radiation therapy (RT) and DBD with RT and BCNU i n patients with high-grade astrocytoma. Methods: A total of 238 patien ts with supratentorial grade 3 and grade 4 astrocytoma were studied. P atients were stratified by age, extent of surgery, tumor grade, and pe rformance score and randomly assigned to receive RT 55-60 Gy and eithe r DBD, 200 mg/m(2) orally on Days 1-10 every five weeks or BCNU, 200 m g/m(2) intravenously every seven weeks. Median age was 60 years; 62% w ere 55 years or older. Eighty-three percent had subtotal resection, 58 % had grade 4 tumors, and 83% had performance scores of 0-2. Results: Survival distributions for all patients in the two arms were similar, with median survival of 41 weeks in each arm. Time to progression dist ributions were virtually identical, with medians of 22 weeks. BCNU pro duced significantly greater hematologic toxicity; median leukocyte and platelet nadirs on the first cycle were 3.6 vs. 4.7 (P = 0.0001) and 117 vs. 162 (P < 0.0001), and overall platelet nadirs were 80.5 vs. 11 4 (P = 0.0019). Non-hematologic toxicities were also significantly gre ater with BCNU, including nausea (57% vs. 31%; P < 0.0001) and vomitin g (45% vs. 17%; P < 0.0001). Conclusion: This trial found no evidence of differences in treatment efficacy when either DBD or BCNU is combin ed with radiation therapy for patients with high-grade astrocytoma.