摘要:
目的:以紫杉醇/顺铂/氟尿嘧啶/亚叶酸(TAX/DDP/5-FU/LV)治疗方案为对照,探讨依立替康/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-11 200 mg/d,静脉滴注2 h,第1天;LV200 mg/d,静脉滴注1 h,第1～5天;5-FU500 mg/d,静脉滴注2 h,第1～5天;对照组:TAX180 mg/d,静脉滴注2 h,第1天;DDP60 mg/d,静脉滴注1 h,第3天;LV200 mg/d,静脉滴注1 h,第1～5天;5-FU500 mg/d,静脉滴注2 h,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CR0例,PR8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。
关键词:
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依立替康 /
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氟尿嘧啶 /
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紫杉醇 /
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顺铂 /
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胃癌 /
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化疗
Abstract:
Objective :To investigate the efficacy and safety of irinotecan(CPT-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.
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