RESULTS OF A RANDOMIZED TRIAL COMPARING INTRAARTERIAL CISPLATIN AND INTRAVENOUS PCNU FOR THE TREATMENT OF PRIMARY BRAIN-TUMORS IN ADULTS - BRAIN-TUMOR COOPERATIVE GROUP TRIAL 8420A

Purpose: To test the efficacy of intra-arterial (IA) cisplatin versus intravenous (IV) PCNU for treating primary brain tumors, in a randomiz ed trial (Brain Tumor Cooperative Group [BTCG] Trial 8420A). Methods: 311 adult patients (ages 19-79 years; median 45) with supratentorial t umors (confirmed histologically) were randomized by nine participating institutions. Patients were required to have completed radiotherapy ( 4500-6020 cGy to the tumor bed) before randomization. Patients were st ratified as either nonprogressive (clinically and radiologically stabl e) or progressive. Results were analyzed for the 311 patients in the r andomized population (RP), and for the 281 patients in the Valid Study Group (VSG) meeting protocol eligibility requirements. 56% of patient s in the VSG had glioblastoma multiforme, 33% had other malignant glio ma, and 11% had low-grade glioma. 64% were stratified as progressive. 12% had received prior chemotherapy. Results: The group randomized to PCNU had the longer survival (p = 0.06 for the RP, p = 0.07 for the VS G). In the VSG, median survival was 10 months for the cisplatin group, 13 months for the PCNU group. The difference between treatment groups was significant (p less than or equal to 0.02) when adjusted for impo rtant prognostic factors. PCNU lead to greater hematotoxicity; cisplat in lead to greater renal toxicity and some ototoxicity. Some cisplatin patients experienced complications associated with IA administration, including six cases of encephalopathy. Conclusion: The trial showed a survival advantage to the group randomized to PCNU, although the diff erence was modest. Coupled with previous BTCG results, these trials su ggest that PCNU is an active drug for brain tumors.