A Pilot Study of Cisplatin, 5-Fluorouracil and High Dose Leucovorin in Chinese Patients with Head and Neck Cancer

Background: Cisplatin, 5-fluorouracil and high dose leucovorin PFL (HDLV) chemotherapy has been reported to be highly active in treatment of head and neck cancer patients. However overall toxicity was high. Before considering PFL (HDLV) chemotherapy for a phase III study in Taiwan, a pilot study of PFL (H DLV) chemotherapy is necessary. Methods: Patients with histologically proven squamous cell carcinoma of head and neck, American Journal Committee on Cancer (AJCC) stage TV, previouly untreated, were eligible for study. Cisplatin 20mg/m^2, 5-fluorouracil (5-FU) 800mg/m^2, leucovorin (LV) 500mg/m^2 were given as a continuous intravenous infusion over 96 hours and the cycle repeated every 28 days. Patients were evaluated for the response and toxicity. Results: Fourteen patients were studied. There were 1 CR (7%) and 8 PR (57%) with a overall response rate (CR+PR) of 64%. The major toxicities were mucositis and myelosuppression. Grade III to IV mucositis occurred in 35% of patients. No treatment related death occurred. Conclusion: Although PFL (HDLV) is an active chemotherapy regiment in head and neck cancer, but its toxicity appears to be excessive. Other PFL regimens that may be equally active but much less toxic should be considered for further evaluation in future studies.