A phase I/II study of tegafur-uracil (UFT) plus oral leucovorin (LV) and biweekly CPT-11 therapy for patients (pts) with metastatic colorectal cancer (CRC)

Abstract

3736 Background: 5-fluorouracil plus leucovorin (5-FU/LV) and CPT-11 therapy is recently widely used as a first line chemotherapy for the treatment of metastatic CRC. We performed a phase I study of UFT/LV, all oral administration regimen, plus biweekly CPT-11 therapy for metastatic CRC and reported that the maximum tolerated dose and the recommended dose (RD) of CPT-11 were 140 and 130mg/m2, respectively (ASCO 2003). Objectives of the present trial were to estimate the response rate (RR) of this regimen. Methods: Eligibility criteria were as follows; histologically proven CRC with measurable metastatic lesions, PS 0–2, age< 80, adequate organ functions, and written informed consent. No prior chemotherapy except adjuvant setting was allowed. UFT/LV was administered orally (UFT: 400 mg/m2/day, LV: 15 mg/body/day) on 5 consecutive days with 2 days' rest for 4 weeks, and CPT-11 was infused at the RD in phase I trial (130mg/m2) on days 1 and 15. This schedule was repeated every 6 weeks. Results: Fourteen of 16 cases were treated by two or more courses of this regimen. Objective responses according to RECIST criteria were observed in 6 of the 14 pts (1 CR and 5 PRs. RR=43%). Six pts were treated without hospitalization, and for other pts 8–14 days of hospitalization in each course was necessary because of the adverse effects. Conclusions: High RR and mild toxicity profile of UFT/LV plus biweekly CPT-11 therapy may be favorable for outpatient clinic. No significant financial relationships to disclose.