FOLFIRI方案二线治疗复发或转移性结直肠癌  

Irinotecan plus fuorouracil/leucovorin （FOLFIRI）as a second line chemotherapy for refractory or metastatic colorectal cancer

作　　者：李健 徐建明[2] 李洁[1] 张晓东[1] 白羽[3] 初玉萍[4] 王永华[5] 刘端琪[6] 金懋林[1] 沈琳[1] 

机构地区：[1]北京大学临床肿瘤学院消化内科,100036 [2]军事医学科学院附属307医院肿瘤内科 [3]北京大学第一医院肿瘤科 [4]首都医科大学附属北京朝阳医院肿瘤科 [5]解放军总医院消化内科 [6]北京军区总医院肿瘤科

出　　处：《中华肿瘤杂志》2008年第3期225-227,共3页Chinese Journal of Oncology

摘　　要：目的探讨FOLFIRI方案（伊立替康＋5-氟尿嘧啶＋醛氢叶酸）用于奥沙利铂治疗失败的复发或转移性结直肠癌的临床疗效和安全性。方法为前瞻性、单组开放式、多中心临床研究。一线化疗失败的结直肠癌患者66例，接受FOLFIRI方案化疗，直至病情进展或不良反应不能耐受。每3个周期评价疗效，并观察不良反应。结果61例患者可评价客观疗效，客观有效率为16．4％，疾病控制率为73．8％。59例患者随访资料完整，中位疾病进展时间（TTP）为5．0个月，中位至死亡时间（TTD）为9．9个月，中位生存时间为18．2个月。不良反应以中性粒细胞减少、恶心呕吐、急性胆碱能综合征、脱发、迟发性腹泻最常见。3和4度中性粒细胞减少的发生率为22．7％。结论FOLFIRI方案二线治疗奥沙利铂化疗失败的晚期结直肠癌，有较高的肿瘤控制率，患者耐受性好，并可以延长患者的总生存期。Objective Irinoteean （ CPT-11 ） , a specific inhibitor of topoisomerase Ⅰ , has been proven to be effective in the treatment of refractory or metastatic eoloreetal cancer. Furthermore, several first line phaseⅢ trials of the combination therapy（FOLFIRI） using CVT-11 and fuorouraeil/leueovorin （5-Fu/LV） were reported to have significant improvement in treatment result. Therefore, we designed a multieenter clinical study to observe the overall survival（OS） , time to death（TTD） , time to progression（TTP） , efficacy and safety of FOLFIRI regimen for patients with refractory or metastatic eoloreetal cancer after first line chemotherapy failure. Methods Patients with metastatic or refractory eoloreetal cancer after first line oxaliplatin-based chemotherapy failure were enrolled into this prospective, one arm and open-labeled multieenter study. Irinoteean 180 mg/m^2 was administered biweekly on D1 ,LV 200 mg/m^2 by intravenous infusion in 2 hours before bolus intravenous injection of 5-Fu 400 mg/m^2, then followed immediately by intravenous infusion of 5-Fu 2.4 g/m2 in 46 hours. OS, TTD, TIP, response rate（RR） and adverse events were assessed according to RSCIST criteria and NCIC-CTG CTCAE （3.0）. Results Sixty-six patients were valuable for safety assessment and and 61 for efficacy. There was no CR patient in this series. Ten patients had PR, 35 SD （ 57.4% ） and 16 PD （ 26.2 % ） with a response rate of 16.4 % （ 10/61 ）. The median TTP was 5.0 months（1-12 months）, median TrD 9.9 months（5-27 months）and median OS 18.2 months （ 7-33 months）. The adverse events including nausea, vomiting, anorexia, diarrhea, leucopenia and cholinergic syndrome were frequent, but usually in Ⅰ - Ⅱ degree. The rate of Ⅲ/Ⅳ degree diarrhea and leucopenia was 7.6% and 22.7%, respectively. Conclusion The regimen of irinotecan plus fuorouracil/leucovorin （FOLFIRI） is effective and well-tolerated as a second-line chemotherapy and may prolong the overall survival for the patient w

关 键 词：结直肠肿瘤 伊立替康 二线治疗 至死亡时间 总生存期 

分 类 号：R686[医药卫生—骨科学]