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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

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Cancer Communications 2018年第1期38卷 655-666页

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 State Key Laboratory of Oncology in South China Collaborative Innovation Center for Cancer MedicineSun Yat-sen University Cancer CenterGuangzhou 510060GuangdongP.R.China Department of Hepatobiliary and Pancreatic Surgery Sun Yat-sen University Cancer CenterGuangzhou 510060GuangdongP.R.China Department of Pathology Sun Yat-sen University Cancer CenterGuangzhou 510060GuangdongP.R.China Department of Medical Imaging Sun Yat-sen University Cancer CenterGuangzhou 510060GuangdongP.R.China

Background:The optimal strategy for adjuvant therapy after curative resection for hepatocellular carcinoma(HCC)patients with solitary tumor and microvascular invasion(MVI)is *** 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 ***: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 ***: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 *** 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],*** 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 *** most common grade 3 or 4 adverse events in both groups were neutropenia and liver ***: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

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