Background/aims: 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.
Methodology: Patients aged > or = 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.
Results: 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.
Conclusions: 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.