Phase I-II trial with cisplatin and 5-FU in recurrent head and neck cancer: an effective outpatient schedule.

Thirty patients with squamous cell carcinoma of the head and neck were treated with a combination of cisplatin (20 mg/m2) and 5-FU (400-200 mg/m2) by iv push on Days 1-5 every 21 days. All patients but two had relapsed disease. Twenty-seven patients were evaluable for response: there were four complete responses and 12 partial responses (objective response rate, 59.2%). The response rate falls to 53.3% if it is calculated on the total number of patients entered. Twenty-seven patients were evaluable for toxicity: myelosuppression occurred in ten patients (37%), while renal toxicity, nausea and vomiting, and stomatitis were quite rare and moderate. These results look encouraging and suggest the need for further studies.