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/m2 on day 1, and vinorelbine, 25 mg/m2 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. © 2002 Wiley Periodicals, Inc. Head Neck 24: 1054–1059, 2002