CPT-11联合CF/5-FU方案治疗胃肠道癌的Ⅰ期临床研究  

Phase Ⅰ study of irinotecan combined with fluorouracil and leucovorin in patients with gastrointestinal cancer

作　　者：李玉升[1] 黄镜[1] 张弘刚[1] 杨林[1] 崔成旭[1] 迟.依荷芭丽 宋岩[1] 张文[1] 胡兴胜[1] 袁芃[1] 王金万[1] 

机构地区：[1]中国医学科学院中国协和医科大学肿瘤医院,北京100021

出　　处：《癌症进展》2004年第2期99-101,共3页Oncology Progress

摘　　要：目的 探索CPT-11(开普拓)联合CF/5-FU治疗胃肠道癌的最大耐受剂量(MTD)和剂量限制性毒性(DLT)。方法 CPT-11初始剂量为120mg/m2,然后150mg/m2,180mg/m2和200mg/m2 iv d1,递增剂量直至出现DLT。CF 200mg/m2 iv 2h,然后5-FU 400mg/m2快速静滴,接着5-FU 600mg/m2持续静滴22h,第1天、第2天给药,2周重复。结果 20例胃肠道癌患者共完成化疗111周期,中位数6周期。MTD为200mg/m2,DLT为腹泻和WBC减少。结论 我们推荐CPT-11180mg/m2联合CF/5-FU每2周重复的方法,作为国内PS为0-1胃肠癌患者的一线二线化疗方案。To determine the maximum - tolerated dose (MTD) and dose - limiting toxicity (DLT) of iri-notecan (CPT-11), fluorouracil (5-FU), and leucovorin (CF) in patients with gastrointestinal cancers. Methods CPT-11 was given at escalating doses until MTD was determined, from the initial dose of 120mg/m2 to 150mg/m2, 180mg/m2 and 200mg/m2 on d1. CF and 5-FU were given at fixed doses, with CF 200mg/m2 infused over 2 hours followed by 5-FU 400mg/m as an introuenous bolus precoding a continous infusion dose of 600mg/m2 over 22 hours on d1 and d2. Treatment cycle was repeated every 2 weeks. Results 20 patients received CPT-11 and CF/5-FU for a total of 111 courses ( median six courses). Diarrhea and neutropenia were dose-limiting toxicities. The MTD of CPT-11 is200mg/m2. Conclusion We recommend CPT-11 180mg/m2 combine with CF / 5-FU at a 2 - week intervals as 1st and 2nd line chemotherapy regimen for Chinese patients with GI cancer at PS 0-1.

关 键 词：CPT-11 胃肠道癌 最大耐受剂量 剂量限制性毒性 

分 类 号：R730.53[医药卫生—肿瘤]