• Riccardo Lencioni, Josep M Llovet, Guohong Han, Won Young Tak, Jiamei Yang, Alfredo Guglielmi, Paik Seung Woon SW Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea., Maria Reig, Kim Do Young DY Yonsei University College of Medicine, Seoul, South Korea., Gar-Yang Chau, Angelo Luca, Luis Ruiz Del Arbol, Marie-Aude Leberre, Woody Niu, Kate Nicholson, Gerold Meinhardt, and Jordi Bruix.
• University of Miami Miller School of Medicine, Miami, FL, USA; Pisa University School of Medicine, Pisa, Italy. Electronic address: rlencioni@med.miami.edu.
• J. Hepatol. 2016 May 1; 64 (5): 1090-1098.

Background & AimsTransarterial chemoembolization with doxorubicin-eluting beads (DC Bead®; DEB-TACE) is effective in patients with Barcelona clinic liver cancer stage B hepatocellular carcinoma (HCC). The multikinase inhibitor sorafenib enhances overall survival (OS) and time-to-tumor progression (TTP) in patients with advanced HCC. This exploratory phase II trial tested the efficacy and safety of DEB-TACE plus sorafenib in patients with intermediate stage HCC.MethodsPatients with intermediate stage multinodular HCC without macrovascular invasion (MVI) or extrahepatic spread (EHS) were randomized 1:1 to DEB-TACE (150 mg doxorubicin) plus sorafenib 400 mg twice daily or placebo. The primary endpoint was TTP by blinded central review. Secondary endpoints included time to MVI/EHS, OS, overall response rate (ORR) using modified response evaluation criteria in solid tumors, disease control rate (DCR), time to unTACEable progression (TTUP), and safety.ResultsOf 307 patients randomized, 154 received sorafenib and 153 received placebo. Median TTP for subjects receiving sorafenib plus DEB-TACE or placebo plus DEB-TACE was similar (169 vs. 166 days, respectively; hazard ratio (HR) 0.797, p=0.072). Median time to MVI/EHS (HR 0.621, p=0.076) and OS (HR 0.898, p=0.29) had not been reached. The ORRs for patients in the sorafenib and placebo groups with post-baseline scans were 55.9% and 41.3%, respectively, and the DCRs were 89.2% and 76.1%, respectively. TTUP was lower with sorafenib than with placebo (HR 1.586; 95% confidence intervals, 1.200-2.096; median 95 vs. 224 days). No unexpected adverse events related to sorafenib were observed.ConclusionSorafenib plus DEB-TACE was technically feasible, but the combination did not improve TTP in a clinically meaningful manner compared with DEB-TACE alone.Copyright © 2016 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.

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