Survival benefit of oral tegafur/uracil and leucovorin as a first line therapy for elderly patients with advanced or metastatic colorectal cancer

This phase II trial was performed to evaluate the efficacy and tolerability of tegafur/uracil (UFT) and oral leucovorin (LV) in elderly patients with advanced or metastatic colorectal cancer who had not received prior chemotherapy.Patients agedor = 70 years were eligible. UFT and LV were taken orally on days 1-28 of the cycle at doses of 300 mg/m2/day and 75 mg/m2/day, respectively. Treatment was administered on an outpatient basis every 35 days and consisted of at least two cycles until disease progression.A total of 30 patients were enrolled in this study. The median age of the patients was 81.5 years (range: 74-88 years). The observed overall response rate was 17.9%. The estimated median overall survival time was 23.5 months. Two patients (7%) experienced toxicities with a worst grade of 3, and one patient (4%) experienced toxicities with a worst grade of 4. There were no treatment-related deaths. No patients experienced grade 3 or 4 hematological adverse events.Although the response rate to UFT/LV was moderate, a favorable survival time was observed. Lower hematological adverse event rate of UFT/LV may introduce second line therapy safely to elderly colorectal cancer patients and contribute longer survival.