297Original Article Decreasing Dosage of Irinotecan, 5-Flurouracil (5-FU) and Leucovorin (LV) in the Treatment of Advanced and /or Metastatic Colorectal Cancer: A Phase II Study

Background: In this study, we attempted to determine the efficacy and toxicity of decreas-ing dosage of irinotecan plus 5-fluorouracil (5-FU) and leucovorin (LV) in the treatment of advanced colorectal cancer. Methods: A total of 250 mg/m2 Irinotecan (CPT-11) intravenous infusion for 90 min-utes was administered every 3 weeks. A 24-hour intravenous infusion with 2000 mg/m2 5-FU and 200 mg/m2 LV was administered through a port-A catheter system weekly for 2 consecutive weeks. Each treatment cycle was repeated every 3 weeks. Progression-free survival and survival curves were drawn according to Kaplan-Meier method. Tumor responses were deter-mined according to the RECIST guidelines. Toxicities were evaluated using the WHO criteria. Results: Thirty-eight patients were enrolled from September 2001 through October 2004. The median number of treatment courses was 8.1 (range, 1-14). Based on the intent-to-treat principle, the response rate was 39.5 % (95 % CI: 25.4-54.4%) which included 5.3 % complete response (CR) and 34.2 % partia