To determine the efficacy and safety profile of the combination of cisplatin and 5-fluorouracil modulatedboth by methotrexate and leucovorin in metastatic/recurrent squamous cell carcinoma of the head and neck.
Twenty-eight patients were treated with cisplatin 40 mg/m2/day continuous infusion for 24 hours on day 1;high-dose 5-fluorouracil 2,000 mg/m2/day and leucovorin 100 mg/m2/day continuous infusion for 48 hours on days 1and 2; methotrexate 40 mg/m2/day as a bolus infusion 4 hours before 5-fluorouracil and leucovorin on day 1. The treat-ment was repeated every 2 weeks in a cycle.
The overall response rate was 25%, and 14% of the patients achieved stable disease status. Subgroup analy-sis demonstrated significantly improved overall survival in the disease-control group (12.0 months vs. 5.3 months, p < 0.001). Only 3 (10.7%) patients developed grade 3–4 neutropenia, and none developed grade 3–4 non-hematologictoxicity.
This multiagent-containing regimen has an excellent safety profile and improved survival in disease-controlgroup of patients with metastatic/recurrent squamous cell carcinoma of the head and neck.