CAJ | 학술논문

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.
목적 탐토경도관간동맥화료전새(TACE)연합색랍비니치료중만기간세포암적료효화안전성.방법 회고성대비분석2008년7월지2010년11월수치적TACE후구복색랍비니적44례중만기간세포암환자(연합조),화동기부행TACE적44례중만기간세포암환자(개입조)적료효.료효판단채용수정후적실체류치료료효평개표준(mRECIST),관찰환자종TACE치료개시지질병진전시간(TTP)、총생존기(OS)、불량사건.결과채용Kaplan-Meier법화Log-rank검험진행생존평고.결과 수방지2011년1월,연합조24례환자존활(54.5％),20례(함실방)사망(45.5％)；개입조13례존활(29.5％),31례(함실방)사망(70.5％)；량조균몰유완전완해(CR)병례,연합조부분완해1례、병조은정24례、질병진전19례,개입조병조은정21례、질병진전23례.질병공제솔(DCR)연합조위56.8％(25/44),개입조위47.7％(21/44),량자차이무통계학의의(x2=0.729,P=0.393).중위OS연합조위21.0[95％가신구간(CI):14.9 ～27.1]개월,개입조위10.0(95％ CI:6.4 ～13.6)개월,량자차이유통계학의의(x2=7.436,P=0.006)；중위TTP연합조위11.0(95％ CI:8.7 ～13.3)개월,개입조위6.0(95％ CI:3.9 ～8.1)개월,량자차이야유통계학의의(x2=10.437,P=0.001).연합조불량반응주요시수족피부반응、식욕하강、발열,핍력、복사등；단순개입조불량반응주요시발열、식욕하강、악심구토、핍력등.기중수족반응、탈발、복사적발생솔연합조고우단순개입조(P치균＜0.05),량조불량반응주요시1～2급,경대증처리후대부분능구완해.결론 TACE연합색랍비니치료중만기간세포암교단용TACE치료능구연장환자OS화TTP,단DCR량조무차이.
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.