肝动脉化疗栓塞联合索拉非尼治疗中晚期肝细胞癌的临床疗效观察
Clinical observation of transcatheter arterial chemoembolization combined with sorafenib on intermediate-advanced hepatocellular carcinoma
目的 探讨经导管肝动脉化疗栓塞(TACE)联合索拉非尼治疗中晚期肝细胞癌的疗效和安全性.方法 回顾性对比分析2008年7月至2010年11月收治的TACE后口服索拉非尼的44例中晚期肝细胞癌患者(联合组),和同期仅行TACE的44例中晚期肝细胞癌患者(介入组)的疗效.疗效判断采用修正后的实体瘤治疗疗效评价标准(mRECIST),观察患者从TACE治疗开始至疾病进展时间(TTP)、总生存期(OS)、不良事件.结果采用Kaplan-Meier法和Log-rank检验进行生存评估.结果 随访至2011年1月,联合组24例患者存活(54.5%),20例(含失访)死亡(45.5%);介入组13例存活(29.5%),31例(含失访)死亡(70.5%);两组均没有完全缓解(CR)病例,联合组部分缓解1例、病灶稳定24例、疾病进展19例,介入组病灶稳定21例、疾病进展23例.疾病控制率(DCR)联合组为56.8%(25/44),介入组为47.7%(21/44),两者差异无统计学意义(x2=0.729,P=0.393).中位OS联合组为21.0[95%可信区间(CI):14.9 ~27.1]个月,介入组为10.0(95% CI:6.4 ~13.6)个月,两者差异有统计学意义(x2=7.436,P=0.006);中位TTP联合组为11.0(95% CI:8.7 ~13.3)个月,介入组为6.0(95% CI:3.9 ~8.1)个月,两者差异也有统计学意义(x2=10.437,P=0.001).联合组不良反应主要是手足皮肤反应、食欲下降、发热,乏力、腹泻等;单纯介入组不良反应主要是发热、食欲下降、恶心呕吐、乏力等.其中手足反应、脱发、腹泻的发生率联合组高于单纯介入组(P值均<0.05),两组不良反应主要是1~2级,经对症处理后大部分能够缓解.结论 TACE联合索拉非尼治疗中晚期肝细胞癌较单用TACE治疗能够延长患者OS和TTP,但DCR两组无差异.
更多Objective To evaluate the treatment effect and security of transcatheter arterial chemoembolization(TACE)combined with sorafinib for intermediate-advanced hepatocellular carcinoma.Methods From July 2008 to November 2010,the treatment effects of two groups of patients with advanced hepatocellular carcinoma were retrospectively analyzed and compared,including 44 patients treated by sorafenib combined with TACE(test group)and the other 44 patients treated only with TACE(control group).To assess the treatment effect based on mRECIST,the time for patients' tumor progression(TTP),overall survival(OS)time and adverse events were recorded.Survival rate were analyzed using KaplanMeier method and Log-rank analysis in SPSS 18.0.Results Till January 2011,24 patients(54.5%)survived and 20 patients(include patients lost to visit)died(45.5%)among the test group,13 patients survived(29.5 %)and 31 patients(include patients lost to visit)died(70.5 %)among the control group.No complete remission condition was observed in all patients.Among the test group,1 patient got partial remission,24 ones remain stable and 19 patients got progression.While among the control group,conditions remained stable in 21 patients and progressed in rest 23 ones.The disease control rate(DCR)in the test group and control group were 56.8%(25/44)and 47.7%(21/44)respectively,with no statistical significance(x2 =0.729,P =0.393).The median overall survival time(mOS)of test group and control group were 21.0(95 % CI:14.9-27.1)months and 10.0(95 % CI:6.4-13.6)months respectively,and the difference reached statistical significance(x2 =7.436,P =0.006).The median time to tumor progression(mTTP)of test group and control group was 1 1.0(95% CI:8.7-13.3)and 6.0(95% CI:3.9-8.1)months respectively,and the difference had statistical significance(x2 =10.437,P =0.001).The adverse events of test group mainly included hand-foot skin reaction,loss of appetite,fever,fatigue and diarrhea.The adverse events of control group mainly included fever,loss of appetite,nausea,vomiting and fatigue.The incidences of hand-foot skin reaction,baldness,diarrhea were significantly higher in test group than those in the control group(P <0.05).In most patients,these side effects were mild-to-moderate,and alleviated remarkablely after symptomatic treatment.Conclusions Compared with TACE alone,TACE combined with sorafenib can prolong the OS and TTP significantly for the patients with intermediate-advanced hepatocellular carcinoma.However,the DCR of the two groups has no statistical significance.
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