A Phase II study of combined oral uracil and ftorafur with leucovorin for patients with squamous cell carcinoma of the head and neck

BACKGROUND. The objective of this Phase II study was to define the response rate, safety profile, and toxicity of oral uracil and ftorafur (UFT) with leucovorin (UFT/ LV) as a palliative treatment for patients with squamous c ell carcinoma of the head and neck (SCCHN). METHODS. Patients with metastatic or recurrent SCCHN with an Eastern Cooper ative Oncology Group performance status < 2 and adequate organ function wer e enrolled in an institutional review board-approved trial. Prior induction or adjuvant chemotherapy was permitted provided 6 months had elapsed since the last chemotherapy. Patients were treated with UFT 300 mg/m(2) per day and leucovorin 90 mg per day administered in three doses daily for 28 days followed by a 7-day break for a 35-day cycle. Planned intrapatient dose mod ifications were based on individual toxicity. Patients were removed from th e study for progression of disease or unacceptable toxicity. RESULTS. One hundred six cycles of UFT/LV had been administered to 42 patie nts as of January 1, 2000. The most common toxicities, in descending order of incidence, were anemia, pain, fatigue, diarrhea, nausea, mucositis, and anorexia. Clinically significant toxicities attributable to UFT/ LV were pr imarily gastrointestinal. On an intent-to-treat basis, three patients (7%) achieved a complete response, and six patients (14%) achieved a partial res ponse. The overall response rate was 21% (95% confidence interval, 10-37%). CONCLUSIONS, UFT/LV therapy is feasible in this patient population and is g enerally well tolerated. Response rates are similar to the rates expected w ith continuous-infusion 5-fluorouracil. UFT/LV should be studied further bo th alone and in combination therapy for patients with SCCHN. (C) 2001 Ameri can Cancer Society.