A multicenter phase II trial of bi-weekly irinotecan (CPT11), infusional 5-fluorouracil (5FU) and leucovorin (LV) with oral tegafur/uracil (UFT) for metastatic colorectal cancer (MCRC)

Abstract

3666 Background: : CPT11 combined with continuous infusional 5FU has shown to be an effective and tolerable regimen in MCRC.UFT enhanced plasma 5FU concentration and anti-tumor effects during 5FU infusion. We examined phase II trial of CPT11/infusional5FU/LV/UFT combined therapy for MCRC. Methods: CPT11; 30 mg/m2 (day1, i.v.1hr), leucovorin (LV); 200 mg/m2 (day1, 2i.v.1hr), 5-fluorouracil (5-FU); 300 mg/m2 (day1, 2c.i.v. in 22hr) bi-weekly, UFT was 400mg/day (day1–14 p.o.). Based on newly available phase I trial results, the CPT11 dose was reduced from 100 to 30 mg/m2 after January 2001. The main endpoint of this trial was the objective tumor response rate (RECIST criteria). Results: Sixteen patients with good performance status (ECOG0–1) entered the trial from February 2001 until May 2002 (9m/7f; median age=62, range39–77). The response rate was 19% (3PR) (RECIST criteria). Stable disease (SD) plus partial response was 100% (16/16). Median time to progression (TTP) was 5.2 months and median survival time (MST) was 20.2 months (95%CI: 14.6–25.8). In total, 416 cycles were administered, with a median of 26cylcles (MC)(range: 5–61). Presence of TTP (P=0.04 loglank) and MC (P=0.02 loglank) correlated with MST.The major toxicity was not recognized. Grade1/2 nausea was common.No treatment related death was recorded. Conclusions: Considering toxicity, TTP and economic burden of a patient, the bi-weekly CPT11/infusional5FU/LV/UFT regimen will be used for further comparative trials of the group. As for this regimen, long-term outcome treatment is possible and the quality of life analyses will be presented at the meeting. No significant financial relationships to disclose.