Phase II Study of Irinotecan, 5-Fluorouracil, and Leucovorin in Relapsed or Metastatic Colorectal Cancer as First-line Therapy
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Abstract
Background: The purpose of this study was to assess the efficacy and toxicity of biweekly irinotecan plus 5-fluorouracil (FU) and leucovorin (LV) in patients with relapsed or metastatic colorectal cancer. Materials and Methods: Between March 2002 and May 2004, 24 patients with histologically confirmed relapsed or metastatic colorectal cancer were enrolled in this study. One chemotherapy cycle consisted of irinotecan 180 mg/m2 on days 1 and 15; 5-FU 400 mg/m2 bolus IV with 600 mg/m2 by a 22 hour intravenous infusion on days 1, 2, 15 and 16; and leucovorin 20 mg/m2 on days 1, 2, 15 and 16, every 4 weeks. Results: The median age of the 24 was 57.5 years (range, 38~69). Their metastatic sites included: the liver (62.5&), lung (20.8&), peritoneum (16.7&), lymph node (12.5&), ovary (8.3&) and pelvis/vagina (8.3&). Twenty- two patients were evaluable for a response. Six and 7 patients achieved partial responses and stable diseases, respectively. The overall response rate was 27.3& (95& Confidence interval; 10.3~44.5&). The median follow-up duration for surviving patients was 14.7 months (range, 1.7~26.5). Median overall survival (OS) and 1-year OS rates were 19 months and 86.3&, respectively. Median response duration and median progression free survival were 7.47 and 5.57 months, respectively. A total of 83 cycles (median 4 cycles) were administered. The main non-hematologic toxicities were nausea/vomiting (44.5&/ 18.1&) and diarrhea (8.4&). The most common hematologic toxicity was NCI grade I/II anemia (31.3&) and grade I/II neutropenia was 10.8&. There was no life-threatening toxicity. Conclusion: The results suggested that irinotecan, 5-FU and leucovorin combination chemotherapy in a biweekly schedule is a practical and tolerable treatment option in patients with advanced colorectal cancer.(Cancer Res Treat. 2004;36:235-239)
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