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
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
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DOI：
10.1093/jjco/hym091
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发表时间：
2007-09-01
影响因子：
2.4
通讯作者：
Ono, Hiroyuki
中科院分区：
文献类型：
--
作者：
Yoshino, Takayuki;Boku, Narikazu;Ono, Hiroyuki
背景：短期输注5-氟尿嘧啶、亚叶酸钙、伊立替康或奥沙利铂已被认为是转移性结直肠癌的标准治疗方案。然而，在2005年初日本批准输注5-氟尿嘧啶方案和奥沙利铂用于治疗转移性结直肠癌之前，伊立替康联合5-氟尿嘧啶/亚叶酸钙一直是标准治疗方案。方法：46例未接受化疗的转移性结直肠癌患者接受改良的伊立替康联合5-氟尿嘧啶/亚叶酸钙方案治疗，包括伊立替康100 mg/m(2)和L-亚叶酸钙10 mg/m(2)静脉滴注，然后5-氟尿嘧啶500 mg/m(2)静脉滴注，每周4周，每6周重复一次，直到病情进展或不可接受毒性为止。结果：总有效率为48%(95%可信区间，95%可信区间)。34-62%)，48%的患者病情稳定。中位无进展生存期为8.3个月，总生存期为20.3个月。3~4级毒性发生率：中性粒细胞减少50%，腹泻4%，乏力13%，恶心7%，呕吐7%。在化疗开始后的60天内，既没有发生与治疗相关的死亡，也没有发生全因死亡。结论：改良伊立替康联合5-氟尿嘧啶/L-亚叶酸钙方案对日本晚期结直肠癌患者是一种有效且耐受性良好的方案，表现出与西方患者不同的毒副作用。
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/m(2)) and L-leucovorin (10 mg/m(2)), and then 5-fluorouracil 500 mg/m(2) 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.