PHASE-II TRIAL OF CISPLATIN IN REFRACTORY CHILDHOOD-CANCER - CHILDRENS-CANCER-STUDY-GROUP REPORT

Abstract

A total of 114 children with solid tumors refractory to conventional therapy were evaluated for response and/or toxic effects after receiving cisplatin at doses of 3.0-4.5 mg/kg with aggressive hydration and mannitol diuresis every 3 wk; a minimum of 2 courses was required for evaluation of response (110 patients). Objective responses were noted in the following 18 patients: rhabdomyosarcoma (3), Wilms'' tumor (3), osteogenic sarcoma (3), Ewing''s sarcoma (2), neuroblastoma (1), undifferentiated sarcoma (1), hepatoblastoma (1), ovarian teratoma (1), hepatocellular carcinoma (1), embryonal carcinoma of the mediastinum (1) and thymoma (1). Twenty-six patients had some evidence of renal toxicity. Asymptomatic hearing loss was commonly found when audiometry was performed (8 of 18 patients tested). Eight additional patients had symptomatic hearing problems, tinnitus or hearing loss. Myelosuppression was mild. Hypomagnesemia and/or hypocalcemia were common but only 1 patient had symptoms. Cisplatin, administered at a dose of 3.0 mg/kg with aggressive hydration and mannitol diuresis, is reasonably well-tolerated. Its role in the therapy for those tumors against which it shows activity remains to be determined.