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Japanese Journal of Clinical Oncology 2005 35(4):214-217; doi:10.1093/jjco/hyi061
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© 2005 Foundation for Promotion of Cancer Research

Phase II Study of Irinotecan, 5-Fluorouracil and Leucovorin as First-line Therapy for Advanced Colorectal Cancer

Sang Hoon Ji, Young Suk Park, Jeeyun Lee, Do Hyoung Lim, Byeong-Bae Park, Keun Woo Park, Jung Hun Kang, Se-Hoon Lee, Joon Oh Park, Kihyun Kim, Won Seog Kim, Chul Won Jung, Young-Hyuck Im, Won Ki Kang and Keunchil Park

Division of Hematology-Oncology. Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea

For reprints and all correspondence: Young Suk Park, Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 50 Ilwon-Dong Kangnam-Ku, Seoul, 135-710, Korea. E-mail: pys27hmo{at}smc.samsung.co.kr

Received August 20, 2004; accepted February 24, 2005

Background: We evaluated the efficacy and tolerability of a modified biweekly irinotecan, 5-fluorouracil and leucovorin regimen (modified Douillard regimen) as the first-line therapy in patients with advanced colorectal cancer.

Methods: A total of 80 patients (41 male, 39 female) with recurrent or metastatic colorectal cancer were enrolled between April 2001 and December 2003. The treatment cycle consisted of irinotecan 150 mg/m2 as a 90 min infusion on day 1, leucovorin 20 mg/m2 intravenous bolus, immediately followed by a 48 h continuous infusion of 5-fluorouracil 3000 mg/m2 on day 1. The primary end-point was response rate, and the secondary end-points were time to progression and toxicity profile.

Results: An overall objective response rate of 38.7% [95% confidence interval (CI) 27.84–49.66%] was achieved. The median time to progression was 6.1 months (95% CI 4.63–7.57 months) and the median overall survival time was 20.2 months (95% CI 15.50–24.90 months). The median duration of follow-up for patients was 16.9 months. The toxicity profile was more favorable than for the conventional Douillard regimen.

Conclusion: We conclude that the modified Douillard regimen may be a practical and more tolerable treatment option in patients with advanced colorectal cancer.

Key Words: colorectal cancer • chemotherapy • irinotecan • 5-fluorouracil • leucovorin


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