Oral regimen consisting of UFT/UZEL for elderly patients with colorectal cancer

A clinical trial has been planned to assess the safety and efficacy of oral administration of UFT and leucovorin (UZEL) in elderly patients with advanced colorectal cancer (CRC).Twenty-six patients with advanced CRC who were over 70 years and considered ineligible for combination chemotherapy received oral UFT 300 mg/day and UZEL 75mg/day were administered orally for 28 days followed by a 7-day rest period. Treatment was repeated every 5 weeks until disease progression.A total of 106 cycles of UFT/UZEL were administered (median, four cycles; range, one to twelve cycles). UFT/UZEL was well tolerated. The response rate was 11% (3 partial responses, 16 stable diseases, and 7 progressive diseases). The median progression-free survival rate was 3.9 months and the median survival time was 9.8 months. Treatment-related grade 3 and 4 adverse events were not observed.Oral regimen consisting of UFT/ UZEL is effective and well tolerated in elderly patients with advanced CRC who are considered ineligible for combination chemotherapy.