Phase II study of the combination of carboplatin and 5-fluorouracil in metastatic nasopharyngeal carcinoma.

A carboplatin and 5-fluorouracil (CF) chemotherapy protocol was designed to evaluate tumor response and toxicity in patients with metastatic nasopharyngeal carcinoma (NPC). Patients with metastatic NPC were treated with a maximum of eight courses of CF. Carboplatin was given at 300 mg/m2 by intravenous bolus on day 1 and 5-fluorouracil at 1 g/m2 per day by continuous infusion on days 1-3; cycles were repeated once every 3 weeks. A total of 42 patients were evaluable for response and toxicity. They received a median of 6 courses (range 2-8) of chemotherapy. The overall response rate was 38% (16/42), comprising 7 complete responses (CR, 17%) and 9 partial responses (PR, 21%). The median survival was 12.1 months (range 6-54.2 months). The treatment was well tolerated. Toxicity was mainly bone marrow suppression. There were four episodes of neutropenic fever, but no renal toxicity or treatment-related death was documented. The combination of carboplatin given at a fixed dose of 300 mg/m2 for 1 day and 5-fluorouracil given at 1 g/m2 per day for 3 days produced an objective response rate of 38% and tolerable side effects.