Cancer Res Treat.  2004 Aug;36(4):235-239.

Phase II Study of Irinotecan, 5-Fluorouracil, and Leucovorin in Relapsed or Metastatic Colorectal Cancer as First-line Therapy

• Won YW
• Lim YH
• Park HY
• Oh HS
• Choi JH
• Lee YY
• Kim IS
• Choi IY
• Ahn MJ

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.

Keyword

Irinotecan; 5-Fluorouracil; Leucovorin; Metastatic colorectal cancer

MeSH Terms

Anemia
Appointments and Schedules
Colorectal Neoplasms*
Diarrhea
Disease-Free Survival
Drug Therapy
Drug Therapy, Combination
Female
Fluorouracil*
Follow-Up Studies
Humans
Infusions, Intravenous
Leucovorin*
Liver
Lung
Lymph Nodes
Neutropenia
Ovary
Peritoneum
Fluorouracil
Leucovorin

Figure

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  Fig. 1 Kaplan-Meier estimate of overall survival.

• 

  Fig. 2 Kaplan-Meier estimate of time to progression.

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