Randomized, prospective, comparative study on the effects and safety of sorafenib vs. hepatic arterial infusion chemotherapy in patients with advanced hepatocellular carcinoma with portal vein tumor thrombosis
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Treatment responses of advanced hepatocellular carcinoma (HCC) with portal vein tumor thrombosis (PVTT) remain unacceptably low and treatment modalities are limited. We compared the efficacy and safety of sorafenib and hepatic arterial infusion chemotherapy (HAIC).
In this randomized, prospective, comparative study, data on 58 patients with advanced HCC with PVTT, with Child–Turcotte–Pugh (CTP) scores of 5–7, were collected from six university hospitals between January 2013 and October 2015. Twenty-nine patients were treated with sorafenib and twenty-nine with HAIC.
The median overall survival (OS) and time to progression (TTP) were significantly longer in the HAIC group than in the sorafenib group (14.9 vs.7.2 months, p = 0.012 and 4.4 vs. 2.7 months, p = 0.010). The objective response (OR) rates were 27.6 and 3.4% in the HAIC and sorafenib groups, respectively (p = 0.001). In univariate analysis, sex, main portal vein invasion and treatment modality were significant prognostic factors of OS (p = 0.044, 0.040, 0.015), whereas cause of HCC, tumor number, tumor location and treatment modality were significant prognostic factors of TTP (p = 0.040, 0.002, 0.034, 0.014). In multivariate analysis, sex and treatment modality were significant prognostic factors of OS (p = 0.008, 0.005), whereas cause of HCC, tumor number, tumor location and treatment modality were significant prognostic factors of TTP (p = 0.038, 0.038, 0.015, 0.011). Major complications included hyperbilirubinemia (44.8%), AST elevation (34.5%), ascites (13.8%) and catheter-related complications (3.4%) in the HAIC group and hyperbilirubinemia (34.5%), hand-foot syndrome (31.0%) and AST elevation (27.6%) in the sorafenib group.
For managing advanced HCC with PVTT, HAIC may be a valuable treatment modality.
KeywordsHepatocellular carcinoma Portal vein tumor thrombosis Sorafenib Hepatic arterial infusion chemotherapy Prognosis
Portal vein tumor thrombosis
Hepatic arterial infusion chemotherapy
Hepatitis B virus
Hepatitis C virus
Modified Union for International Cancer Control
Eastern Cooperative Oncology Group
Absolute neutrophil count
Time to progression
Barcelona Clinic Liver Cancer
European Association for the Study of Liver
Magnetic resonance imaging
Modified Response Evaluation Criteria in Solid Tumors
Compliance with ethical standards
Conflict of interest
The authors have no conflicts of interest to declare.
All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.
Informed consent was obtained from all individual participants included in the study.
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