A phase II trial of cisplatin and vinorelbine in patients with recurrent or metastatic squamous cell carcinoma of the head and neck.
OBJECTIVE: We assessed the response rate and the toxicity of cisplatin plus vinorelbine in patients with this condition. PATIENTS AND METHOD: Forty-two patients were included. Therapy consisted of cisplatin, 100 mg/m(2) on day 1, and vinorelbine, 25 mg/m(2) on days 1 and 8, given every 21 days. Therapy was continued up to six courses or progressive disease. RESULTS: One hundred fifty-nine courses were given (median, three per patient). Dose reduction was applied in 13% of courses and 43% of patients. Grade 3 to 4 neutropenia appeared in 11% of courses and 35% of the patients. One patient died of febrile neutropenia. Ten percent of patients attained a complete response, and 23% attained a partial response (overall 33%, 95%CI 19%-47%). The median duration of response and median survival were 6 months. Twenty-four percent of patients remain alive at 1 year. CONCLUSIONS: The combination of cisplatin and vinorelbine is moderately active in patients with recurrent or metastatic carcinomas of the head and neck and avoids the inconvenience of prolonged infusions of 5-fluorouracil.