CISPLATIN, 5-FLUOROURACIL AND INTERFERON-ALPHA-2B FOR RECURRENT OR METASTATIC HEAD AND NECK-CANCER

On the basis of preclinical data suggesting the possibility of maximis ing the efficacy of 5-fluorouracil and cisplatin by interferon, a pilo t clinical trial was initiated in recurrent and/or metastatic head and neck cancer. Thirty-four patients were treated with cisplatin at 100 mg m(-2), followed by 5-fluorouracil at 1,000 mg m(-2) by continuous i nfusion for 5 days. Interferon alpha 2b was administered at the dose o f 3 million U i.m. daily for 7 days, beginning the day before chemothe rapy. Courses were repeated every 3 weeks. Two patients achieved a com plete remission, six a partial response, 14 had stable disease and 12 progressed on therapy, for an overall response rate of 23% (95% confid ence interval 10-36%). Median survival time was 5 months. Toxicity was severe. Stomatitis, diarrhoea and myelosuppression were the most comm on side-effects. Because of the poor response rate and the presence of severe toxicity, in our opinion further clinical trials in head and n eck cancer should be attempted only after a better definition in precl inical studies of interactions among 5-fluorouracil, cisplatin and int erferon.