Adjuvant transcatheter arterial chemoembolization after curative resection for hepatocellular carcinoma patients with solitary tumor and microvascular invasion: a randomized clinical trial of efficacy and safety  

作　　者：Wei Wei Pei-En Jian Shao-Hua Li Zhi-Xing Guo Yong-Fa Zhang Yi-Hong Ling Xiao-Jun Lin Li Xu Ming Shi Lie Zheng Min-Shan Chen Rong-Ping Guo 

机构地区：[1]State Key Laboratory of Oncology in South China,Collaborative Innovation Center for Cancer Medicine,Sun Yat-sen University Cancer Center,Guangzhou 510060,Guangdong,P.R.China [2]Department of Hepatobiliary and Pancreatic Surgery,Sun Yat-sen University Cancer Center,Guangzhou 510060,Guangdong,P.R.China [3]Department of Pathology,Sun Yat-sen University Cancer Center,Guangzhou 510060,Guangdong,P.R.China [4]Department of Medical Imaging,Sun Yat-sen University Cancer Center,Guangzhou 510060,Guangdong,P.R.China

出　　处：《Cancer Communications》2018年第1期655-666,共12页癌症通讯（英文）

基　　金：supported by the National Natural Science Foundation of China(No.81172037);Science and Technology Program of Guangdong Province,China(No.2013B021800159);Clinical Trials Project(308 Project)of Sun Yat-sen University Cancer Center(No.308-2015-014).

摘　　要：Background:The optimal strategy for adjuvant therapy after curative resection for hepatocellular carcinoma(HCC)patients with solitary tumor and microvascular invasion(MVI)is controversial.This trial evaluated the efficacy and safety of adjuvant transcatheter arterial chemoembolization(TACE)after hepatectomy versus hepatectomy alone in HCC patients with a solitary tumor≥5 cm and MVI.Methods:In this randomized,open-labeled,phase III trial,HCC patients with a solitary tumor≥5 cm and MVI were randomly assigned(1:1)to receive either 1-2 cycles of adjuvant TACE after hepatectomy(Hepatectomy-TACE)or hepatectomy alone(Hepatectomy Alone).The primary endpoint was disease-free survival(DFS);the secondary end-points included overall survival(OS)and adverse events.Results:Between June 1,2009,and December 31,2012,250 patients were enrolled and randomly assigned to the Hepatectomy-TACE group(n=125)or the Hepatectomy Alone group(n=125).Clinicopathological characteristics were balanced between the two groups.The median follow-up time from randomization was 37.5 months[interquartile range 18.3-48.2 months].The median DFS was significantly longer in the Hepatectomy-TACE group than in the Hepatectomy Alone group[17.45 months(95%confidence interval[CI]11.99-29.14)vs.9.27 months(95%CI 6.05-13.70),hazard ratio[HR]=0.70(95%CI 0.52-0.95),P=0.020],respectively.The median OS was also significantly longer in the Hepatectomy-TACE group than in the Hepatectomy Alone group[44.29 months(95%CI 25.99-62.58)vs.22.37 months(95%CI 10.84-33.91),HR=0.68(95%CI 0.48-0.97),P=0.029].Treatment-related adverse events were more frequently observed in the Hepatectomy-TACE group,although these were generally mild and manageable.The most common grade 3 or 4 adverse events in both groups were neutropenia and liver dysfunction.Conclusion:Hepatectomy followed by adjuvant TACE is an appropriate option after radical resection in HCC patients with solitary tumor≥5 cm and MVI,with acceptable toxicity.

关 键 词：Solitary tumor Hepatocellular carcinoma Adjuvant therapy Transcatheter arterial chemoembolization Hepatectomy alone Microvascular invasion 

分 类 号：R73[医药卫生—肿瘤]