CPT-11联合5-FU/FA方案治疗局部晚期或转移性结直肠癌的临床研究

目的评价CPT-11(开普拓)联合5-FU/FA治疗局部晚期或转移性结直肠癌的临床疗效及不良反应.方法符合收治标准者19例,可评价疗效者17例,入组Arm A方案8例,Arm B方案9例,ArmA方案:CPT-11270mg/m2静滴d1;FA200mg/m2,5-FU 425mg/m2分别静滴,均d1～5,每3周重复,两次CPT-11(6周)评价疗效.ArmB方案:CPT-11 180mg/m2静滴d1,LA200mg/m2,静滴d1～2,5-FU 400mg/m2静推,然后5-FU 600mg/m2,d1～2,每2周重复,应用3次CPT-11(6周)为一个周期.结果17例患者,CR 1例,PR 5例,SD 9例,PD 2例,总缓解率35%,稳定率52.9%,中位缓解时间7.5个月,中位稳定时间5个月.主要剂量限制毒性为迟发性腹泻及中性粒细胞减少.结论CPT-11联合5-FU/FA两种方案治疗局部晚期或转移性结直肠癌有较高的疾病缓解率和稳定率,主要剂量限制毒性为迟发性腹泻及中性粒细胞减少.

Clinical study of CPT-11 combined with 5-FU/FA policy in patients with advanced or metastatic colorectal cancer

iective To evaluate the clinical efficacy and adverse effects of irrinotecan(CPT-11) combined with FU/FA in the treatment of advanced or metastatic colorectal cancer. Methods Ninteen cases of metastatic colorectal cancer patients were treated, and 17cases were evaluahle for eaicacy. Of Which 8 cases were grouped with Arm A policy and 9 cases were grouped with Arm B policy. Arm A policy: CPT-11 270mg/m2 ivgtt d1; FA 200mg/m2 ivgtt d1-5; 5-FU 425mg/m2 d1-5, every 3 weeks repeated, a cycle was 6 weeks. Arm B: CPT-11 180mg/m2 ivgtt d1, LA200mg/m2 ivgtt follow by 5-FU 400mg/m2 iv and 5-FU 600mg/m2 ivgtt d1, 2 every 2 weeks repeated, a cycle was 6 weeks. Results In 17 evaluabfle patients, one case had completeresponse, 5 cases had partial response, 9 cases had stable disease and 2 with progressive disease. The Response rate of the whole groups was 35.0% and the stable rate was 52.9% . Dose limting toxicity (DLT) was delayed diarrhea and neutropenia. Conclusion The two policy of CPT-11 combined with FU/FA had higher response rate and stable rate in treatment metastatic colorectal cancer. Main DLT are delayed diarrhea and neutropenia .