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Japanese Journal of Clinical Oncology Advance Access originally published online on August 24, 2007
Japanese Journal of Clinical Oncology 2007 37(9):686-691; doi:10.1093/jjco/hym091
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© 2007 Foundation for Promotion of Cancer Research

Efficacy and Safety of an Irinotecan plus Bolus 5-Fluorouracil and L-Leucovorin Regimen for Metastatic Colorectal Cancer in Japanese Patients: Experience in a Single Institution in Japan

Takayuki Yoshino, Narikazu Boku, Yusuke Onozawa, Shuichi Hironaka, Akira Fukutomi, Yuichiro Yamaguchi, Noriaki Hasuike, Kentaro Yamazaki, Nozomu Machida and Hiroyuki Ono

Division of Gastrointestinal Oncology, Shizuoka Cancer Center, Shizuoka, Japan

For reprints and all correspondence: Takayuki Yoshino, Division of Gastrointestinal Oncology, Shizuoka Cancer Center, 1007 Shimonagakubo, Nagaizumi-cho, Sunto-gun, Shizuoka 411-8777, Japan; E-mail: t.yoshino{at}scchr.jp

Received January 4, 2007; accepted May 17, 2007

Background: Short-term infusion of 5-fluorouracil with leucovorin in combination with irinotecan or oxaliplatin has been considered as standard treatment for metastatic colorectal cancer. However, until infusion of 5-fluorouracil regimens and oxaliplatin was approved for the treatment of metastatic colorectal cancer in Japan early in 2005, combination of irinotecan with bolus 5-fluorouracil/leucovorin had been the standard treatment. This retrospective study evaluates the efficacy and safety of a modified irinotecan with bolus 5-fluorouracil/leucovorin regimen in Japanese colorectal cancer patients.

Methods: Forty-six patients untreated with chemotherapy for metastatic colorectal cancer received a modified form of the irinotecan with bolus 5-fluorouracil/leucovorin regimen, consisting of intravenous irinotecan (100 mg/m2) and L-leucovorin (10 mg/m2), and then 5-fluorouracil 500 mg/m2 as an intravenous bolus infusion, weekly for 4 weeks, repeated every 6 weeks until progression or unacceptable toxicity.

Results: The overall response rate was 48% (95% confidence interval, 34–62%), and 48% of patients had stable disease. Median progression-free survival was 8.3 months and overall survival was 20.3 months. The incidence of grade 3 or 4 toxicity was as follows: neutropenia, 50%; diarrhea, 4%; fatigue, 13%; nausea, 7%; and vomiting, 7%. Neither treatment-related nor all-cause mortality occurred within 60 days of chemotherapy initiation. Despite the limited availability of oxaliplatin, 29 patients received an oxaliplatin-based regimen after progression.

Conclusion: A modified irinotecan plus bolus 5-fluorouracil/L-leucovorin regimen was an active and well-tolerated regimen in Japanese patients with advanced colorectal cancer, showing a different toxicity profile from Western patients.

Key Words: colorectal cancer • 5-fluorouracil • irinotecan • L-leucovorin • IFL regimen


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