依立替康/氟尿嘧啶/亚叶酸三药联用治疗晚期胃癌的临床疗效观察

Clinical study on combination chemotherapy with irinotecan,fluorouracil,and leucovorin in patients with advanced gastric carcinoma

目的：以紫杉醇／顺铂／氟尿嘧影亚叶酸（TAX／DDP／5-FU／LV）治疗方案为对照，探讨依立替影氟尿嘧啶／亚叶酸（CPT-11／5-FU／LV）联合用药治疗进展期胃癌的疗效和安全性。方法：63例不能手术切除或已有转移的胃癌患者随机分为2组，治疗组：CTP-11 200mg／d，静脉滴注2h，第1天；LV200mg,／d，静脉滴注1h，第1～5天；5-FU 500mg／d，静脉滴注2h，第1—5天；对照组：TAX 180mg／d，静脉滴注2h，第1天；DDP 60mg／d，静脉滴注1h，第3天；LV 200mg／d，静脉滴注1h，第1～5天；5-FU 500mg／d，静脉滴注2h，第1～5天。两组均3周为1个周期，治疗至少2个周期，观察其有效率、生存期和毒副作用。结果：治疗组：可评价病例31例，其中CR0例，PR8例（25．8％），SD12例（38．7％），PD11例（35．5％），总有效率25．8％（8／31）；对照组：可评价病例29例，其中CR 0例，PR 8例（27．6％），SD 12例（41．4％），PD 9例（31．0％），总有效率27．6％（8／29）；两组有效率无显著性差异。治疗组和对照组中位生存期分别为7．7个月和8．3个月，1年生存率分别为34．4％和41．4％，两组比较无显著性差异。毒副作用主要为中性粒细胞下降、肝功能损伤、神经毒性、恶心、呕吐、腹泻等，多表现为Ⅰ、Ⅱ度，治疗组的腹泻发生率显著高于对照组；Ⅲ、Ⅳ度反应主要为中性粒细胞下降及神经毒性，治疗组发生率显著低于对照组。没有出现治疗相关性死亡。结论：CPT-11／5-FU／LV静滴给药是治疗进展期胃癌的有效化疗手段，毒性反应较低，但合理剂量和疗程还需进一步的大样本治疗观察。

Objective： To investigate the efficacy and safety of irinotecan （CFF-11 ） plus fluorouracil （5-FU） and leucovorin （LV） in patients with advanced gastric carcinoma, in reference to those of paclitaxel （TAX） and cisplatin （DDP） combined with 5- FU and LV. Methods：63 Patients with untreated advanced gastric carcinoma were randomly enrolled into treatment group and control group. The treatment group were treated with CTP-11 200 mg on day 1, LV 200 mg and 5-FU 500 mg on day 1 - 5 while the control group were given TAX 180 mg on day 1, DDP 60mg on day 3, LV 200 mg and 5-FU 500 mg on day 1 - 5. Both regimens were repeated every 3 weeks. All the patients received at least two treatments and were evaluable for response rate, survival time, and adverse effect. Results： In 31 evaluable patients in treatment group, CR 0 case, PR 8 cases （25.8 % ）, SD 12 cases （38.7 % ）, and PD 11 cases （35.5 % ）. The response rate was 25.8 % （8/31）. In 29 evaluable patients in control group, CR 0 case, PR 8 cases （27.6 % ）, SD 12 cases （41.4 % ）, and PD 9 cases （31.0 % ）. The response rate was 25.8 % （ 8/31 ）. No significant difference was found in terms of response rate between two groups. The median survival and 1-year survival rates were 7.7 and 8.3 months, and 34. 4 % and 41.4 % for both groups, respectively. There was no significant difference between two groups. The most common drug-related adverse effects, mainly grade Ⅰ and Ⅱ , included neutropenia, hepatic toxicity, neurotoxicity, diarrhea, nausea, and vomiting. The incidence rate of diarrhea in treatment group was significantly higher than that in control group. Adverse effects of grade Ⅲ and Ⅳ rested on neutropenia and neurotoxicity, and the incidence rate in treatment group was significantly lower than that in control group. No treatment-related death occurred. Conclusion：Intravenous drip of CPT-11/5-FU/LV seems an active approach for untreated advanced gastric carcinoma with tolerated side effects. Further extensive investigations concerning the dose and course of treatment are demand.