A phase III randomised trial of cisplatinum, methotrextate, cisplatinum + methotrexate and cisplatinum + 5-FU in end stage squamous carcinoma of the head and neck

Abstract

We describe a phase III trial on 200 patients with end stage squamous cell carcinoma of the head and neck. The patients were randomised to one of four treatment arms: cisplatinum alone, methotrexate alone, cisplatinum + 5-FU and cisplatinum + methotrexate. There was no significant difference in the response rates, but the survival of the cisplatinum arm was significantly better than that of the methotrexate arm. The survival of patients receiving cisplatinum as a single agent was longer than that of patients receiving cisplatinum in combination with methotrexate or 5-FU, but not significantly so. Nausea/vomiting and anaemia were significantly more common in the cisplatinum arms than in the methotrexate arm, but the toxicity of combination regimens was not significantly greater than that of cisplatinum used as a single agent.