Phase II study of UFT with leucovorin and irinotecan (TEGAFIRI):: first-line therapy for metastatic colorectal cancer

This phase II trial was performed to evaluate the efficacy and tolerability of oral tegafur - uracil ( UFT (R)) with leucovorin ( LV) combined with intravenous ( i. v.) irinotecan every 3 weeks ( TEGAFIRI) as first- line treatment for patients with metastatic colorectal cancer ( mCRC). Patients received oral UFT 250 mgm(-2) day (-1) and LV 90 mg day(-1) in three divided daily doses for 14 days followed by a 1- week rest and i. v. irinotecan 250 mgm(-2) as a 90- min infusion every 3 weeks. Tumour responses, assessed every two cycles using RECIST criteria, were reviewed by an independent review committee. In 52 evaluable patients, the best overall response rate was 33% ( 95% confidence intervals ( CI) 20 - 47%; 1 complete and 16 partial responses). The median time to progression was 5.4 months ( 95% CI 3.02 - 7.52 months) and median overall survival was 14.9 months ( 11.73 - 17.97 months). A total of 307 cycles were administered, with a median number of five cycles per patient ( range: 1 - 10). The most common grade 3/ 4 toxicities were neutropenia ( 25% of patients), diarrhoea ( 22%), vomiting ( 11%) and anaemia ( 11%). The TEGAFIRI regimen is a feasible, welltolerated and convenient treatment option for patients with non- resectable mCRC.