Phase II Study of Irinotecan, Leucovorin, 5-Fluorouracil and Tegafur/Uracil for Metastatic Colorectal Cancer

Abstract

Irinotecan combined with continuous-infusion 5-fluorouracil (5FU) has been shown to be an effective and tolerable regimen in the treatment of metastatic colorectal cancer (MCRC). Tegafur/uracil (UFT) during 5FU infusion enhances plasma 5FU concentration, mimics continuous 5FU infusion and delivers the drug to target tumor cells. We conducted a phase II trial of four-agent combined therapy for MCRC, giving patients (pts) intravenous irinotecan (30 mg/m2 on day 1), leucovorin (LV, 200 mg/m2 on day 1 and 2), 5FU (300 mg/m2 on day 1 and 2), and UFT (400 mg/day for 14 days). The main endpoint was the objective tumor response rate. Sixteen pts with a good performance status were enrolled from February 2001 to May 2002. The response rate was 19% (3 partial responses), and 13 pts had stable disease. The median time to progression was 5.2 months, and the median survival time was 20.2 months. Considering the low toxicity and reasonable cost, this regimen deserves further investigation.

A phase I study of oral UFT/leucovorin and irinotecan, plus radiation for locally recurrent rectal cancer

“…Considering an effect of systemic chemotherapy is also required for locally recurrent rectal cancer. There are several reports investigating the systemic effects of UFT/LV/ CPT-11 in combination with chemotherapy for metastatic colorectal cancer [11][12][13][14][15] . According to these results, the response rate was almost 50%, and the progression-free survival was seven months.…”

“…Combination chemotherapy of UFT/LV plus irinotecan (CPT-11) seems to be an attractive option in the treatment of metastatic colorectal cancer, because of their ease of administration. Some phase II studies have shown that the UFT/LV/CPT-11 combination chemotherapy is effective and well tolerated for metastatic colorectal cancer [11][12][13][14][15] . Giralt et al reported a phase II trial of preoperative CRT with UFT/LV in patients with advanced rectal cancer 16) .…”