改良FOLFIRI方案用于奥沙利铂和氟尿嘧啶类药物治疗失败的晚期结直肠癌临床研究

Multicenter phase Ⅱ study of modified FOLFIRI regimen in the advanced colorectal cancer patient refractory to fluoropyrimidine and oxaliplatin

目的评价改良的FOLFIRI(mFOLFIRI)方案用于奥沙利铂和氟尿嘧啶类药物治疗失败的晚期结直肠癌的疗效和安全性。方法对奥沙利铂和氟尿嘧啶类药物治疗失败的83例晚期结直肠癌患者,采用mFOLFIRI方案治疗。伊立替康180 mg／m2,静脉滴注90 min,第1天;甲酰四氢叶酸(LV)200 mg/m2,静脉滴注2 h,第1天;5-氟尿嘧啶(5-Fu)400 mg／m2,静脉推注,第1天;5-Fu 2．4 g/m2,静脉滴注46 h(泵);每14天重复。观察疗效和不良反应。结果80例可评价疗效患者中,部分缓解(PR)10例(12．5％),稳定(SD)51例(63．7％),疾病进展(PD)19例(23．8％)。中位至疾病进展时间96 d。83例患者可评价安全性。最常见的Ⅲ、Ⅳ度毒性是中性粒细胞减少(24．1％)、恶心、呕吐(8．4％)和延迟性腹泻(2．4％)。结论mFOLFTRI方案应用于奥沙利铂和氟尿嘧啶类药物治疗失败的晚期结直肠癌安全有效。

Objective To evaluate the efficacy and safety of modified FOLFIRI regimen in advanced colorectal cancer （CRC） patients refractory to fluoropyrimidine and oxaliplatin. Methods The modified FOLFIRI regimen consisted of intravenous infusion of irinotecan 180 mg/m^2 dl ＋ LV 200 mg/m^2 dl ＋ 5-Fu 400 mg/m^2 bolus dl plus 46-hour intravenous infusion of 5-Fu 2.4 g/m^2 , every 2 weeks as one cycle. The main selection criterion for this study was the advanced CRC refractory to fluoropyrimidine and oxaliplatin. Results Of the 80 evaluable patients for efficacy： 10 （ 12.5% ） had a partial response, 51 （63.7%） stable disease, and 19 （23.8%） progressive disease. The median time to progression was 96 days. Safety analysis was based on the data of 83 evaluable patients. The most frequently observed grade 3 or 4 toxicities were neutropenia （24. 1% ）, nausea/vomiting （8.4%）, and diarrhea （2.4%）. Conclusion Modified FOLFIRI regimen is effective and well tolerated in patients with advanced colorectal cancer refractory to fluoropyrimidine and oxaliplatin.