A randomized phase III trial of cisplatinum, methotrexate, cisplatinum + methotrexate, and cisplatinum + 5-fluoro-uracil in end-stage head and neck cancer.

In a previous phase III trial of chemotherapy for patients with end-stage squamous cell carcinoma of the head and neck we have shown that Bleomycin shortened the survival period, compared with untreated controls. The survival of patients treated with Cisplatinum and Bleomycin did not differ significantly from untreated patients, but Cisplatinum significantly prolonged survival. A further similar trial is reported here, the four treatment arms were Methotrexate alone, Cisplatinum alone, Cisplatinum + Methotrexate, and Cisplatinum + 5-Fluoro-uracil. The response rates were: Methotrexate alone 19%, Cisplatinum alone 40%, Cisplatinum + Methotrexate 31%, and Cisplatinum + 5-Fluoro-uracil 33%. The median survival time for the Cisplatinum alone group, 260 days, was significantly longer than the 80 days for the Methotrexate alone group. The median survival times for Cisplatinum + Methotrexate (160 days) and for Cisplatinum + 5-Fluoro-uracil (200 days) did not differ significantly from that for Cisplatinum alone.