依立替康 (Irinotecan ,CPT -11)治疗晚期大肠癌临床研究

Clinical study of irinotecan in Chinese patients with metastatic colorectal cancer

目的 :评价CPT 11(商标名 :开普拓 )单药治疗晚期大肠癌的临床疗效及其不良反应。材料与方法 :从 1997年 11月至 1999年 3月入选晚期大肠癌 6 9例 ,符合收治标准者 6 1例 ,可评价疗效者 5 0例 ,其中 ,以前未接受过任何化疗的病人 2 5例 ,经过一个 5FU为主方案化疗后耐药的病人 2 5例。CPT 113 0 0mg/m2 ,静脉点滴 ,每 3周为一疗程。除PD病人外 ,至少用药 3周期。结果 :在可评价病例中 ,8例 ( 16 .0 % )获PR ,第一线及第二线病人缓解率分别为 12 .0 %及 2 0 .0 % ,中位缓解时间 5 .42个月。全部可评价病例中位进展时间 3 .75个月。 4%及5 2 %病人分别获MR或稳定。主要剂量限制性毒性为迟发性腹泻 (Ⅲ、Ⅳ度 2 7.5 % )及中性粒细胞减少 (Ⅲ、Ⅳ度47.8% ) ,因治疗毒性死亡一例。结论 :CPT 11是治疗晚期大肠癌的有效药物 ,对 5 FU耐药的病例仍可有效 ,主要剂量限制性毒性为迟发性腹泻与中性粒细胞减少 。

Objective:To evaluate the clinical efficacy and adverse effects of irinotecn (CPT 11) in the treatment of metastatic colorectal cancer. Methods:From November 1997 to March 1999,69 cases of metastatic colorectal cancer patients were treated with single drug CPT 11 300 mg/m 2 iv infusion every 3 weeks. All these patients were evaluable for toxicity,50 cases were evaluable for response including 25 chemonaive patients and 25 patients who failed one of 5 Fu based regimens. Results:The response rate of the whole group was 16.0%(12.0%for first line and 20.0%for second line). The median respond period was 5.42 month (4.44～7.79). Median time to progression was 3.75 months (2.10～4.47). Dose limiting toxicity (DLT) was delayed diarrhea (Grade 3+4 cases 27.5%) and neutropenia (grade 3+4 cases 47.8%). One case died of toxicity. These results are very similar to the reported experience in Western countries. Conclusions:CPT 11 is an active drug for advanced colorectal cancer,in chemonaive as well as 5 Fu resistant cases. Main DLT are delayed diarrhea and neutropenia. The efficacy and toxicity of this drug in Chinese patients are comparable to the experience in US and Europe.