A phase III randomized study comparing cisplatin and fluorouracil as single agents and in combination for advanced squamous cell carcinoma of the head and neck.

摘要: Purpose To determine whether combination chemotherapy is superior to single agents for recurrent/metastatic head and neck cancer, we compared the efficacy toxicity of cisplatin (CP) fluorouracil (5-FU), alone in a phase III trial. Patients methods Two hundred forty-nine patients with recurrent cancer were randomized one three treatments: CP (100 mg/m2) 5-FU (1 g/m2 x 4), CP, or every 3 weeks. Results The overall response rate (32%) was that (17%) (13%) (P = .035). Response associated good performance status (PS) but not primary site, site recurrence, histology, prior irradiation, relative dose intensity. Median time progression less than 2.5 months, there no significant difference median survival (5.7 months) among groups. By multivariate analysis, better PS poorly differentiated tumors had survival. Hematologic alopecia worse arm. Conclusion Although plus achieved agents, did improve.