固定剂量率吉西他滨联合奥沙利铂治疗晚期肝细胞癌的临床对比研究

目的:对比研究吉西他滨方案治疗晚期肝细胞癌的疗效和毒副作用。方法:70例晚期肝细胞癌患者随机分为试验组和常规GEMOX组,试验组均接受吉西他滨1 000 mg/m2[电脑泵以10 mg/(min.m2)速度输注]d1,8+奥沙利铂130 mg/m2d1 q3w。常规GEMOX组:吉西他滨1 000 mg/m2(输注30 min)d1,8+奥沙利铂130 mg/m2d1 q3w。结果:试验组RR率为19.4%,DCR率为45.2%,中位mPFS为5.6月,中位mOS为11.3月;常规GEMOX组RR率为14.8%,DCR率为48.1%,中位mPFS为5.3月,mOS为10.6月。两组RR率、DCR率均无显著差异(P>0.05)。两组中位mOS及中位mPFS亦无显著性差异(P>0.05)。两组毒性发生率均不高,安全性较好。其中试验组相比于常规GEMOX组的中性粒细胞减少、胃肠道反应发生率显著低于常规GEMOX组。结论:吉西他滨固定剂量率静滴联合奥沙利铂治疗晚期肝细胞癌疗效与常规GEMOX无显著差异,不良反应较轻。

Comparison of Fixed-dose Rate Gemcitabine Infusion Combined with Oxaliplatin and Routine GEMOX Regimen in Treatment of Patients with Advanced Hepatocellular Carcinoma

Objective:To Compare efficiency and toxicity of Fixed-dose Rate Gemcitabine Infusion Combined with Oxaliplatin and routine GEMOX regimen in treatment of patients with advanced hepatocellular carcinoma.Methods:Seventy cases with advanced HCC were randomized into a test group,given gemcitabine at the dose of 1 000 mg/m2,10 mg/(m2·min) intravenous infusion,d1,8 plus oxaliplatin at 130 mg/m2 intravenous drip 2h on d1.Every 3 weeks as a cycle,and a control group,given routine GEMOX regimen(gemcitabine at the dose of 1 000 mg/m2,intravenous infusion 30 mins,d1,8 plus at 130 mg/m2 intravenous drip 2h on d1.Every 3 weeks as a cycle.Results:In test group,the overall response rate was 19.4%.The overall disease control rate was 45.2%,median progression-free survival(mPFS) was 5.6 months and the median overall survival(OS) was 11.3 months.In the routine GEMOX regimen group,The overall response rate was 14.8%.The overall disease control rate was 48.1%,median progression-free survival(mPFS) was 5.3 months and the median overall survival(mOS) was 10.6 months.There are no significant difference in RR,DCR,mPFS,mOS(P>0.05) between two groups.The main toxicity was slight.The possibility of neutropenia,nausea and vomiting in test group was significant lower than routine GEMOX group.Conclusion:There are no significant difference of efficacy between Fixed-dose Rate Gemcitabine Infusion Combined with Oxaliplatin and routine GEMOX regimen in treatment of patients with advanced hepatocellular carcinoma.But toxicity in Former is lower.