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Title: Brivanib as adjuvant therapy to transarterial chemoembolization in patients with hepatocellular carcinoma: A randomized phase III trial
Authors: Masatoshi Kudo
Guohong Han
Richard S. Finn
Ronnie T.P. Poon
Jean Frederic Blanc
Lunan Yan
Jijin Yang
Ligong Lu
Won Young Tak
Xiaoping Yu
Joon Hyeok Lee
Shi Ming Lin
Changping Wu
Tawesak Tanwandee
Guoliang Shao
Ian B. Walters
Christine Dela Cruz
Valerie Poulart
Jian Hua Wang
Kindai University School of Medicine
The Fourth Military Medical University
David Geffen School of Medicine at UCLA
The University of Hong Kong
CHU Hopitaux de Bordeaux
West China Hospital of Sichuan University
Changhai Hospital
Guangdong General Hospital
Kyungpook National University Hospital
Hunan Provincial Tumor Hospital
SungKyunKwan University, School of Medicine
Chang Gung Memorial Hospital
First People's Hospital of Changzhou
Mahidol University
Zhejiang Cancer Hospital
Bristol-Myers Squibb
Bristol-Myers Squibb
Zhongshan Hospital Shanghai
Keywords: Medicine
Issue Date: 1-Jan-2014
Citation: Hepatology. Vol.60, No.5 (2014), 1697-1707
Abstract: © 2014 by the American Association for the Study of Liver Diseases. Transarterial chemoembolization (TACE) is the current standard of treatment for unresectable intermediate-stage hepatocellular carcinoma (HCC). Brivanib, a selective dual inhibitor of vascular endothelial growth factor and fibroblast growth factor signaling, may improve the effectiveness of TACE when given as an adjuvant to TACE. In this multinational, randomized, double-blind, placebo-controlled, phase III study, 870 patients with TACE-eligible HCC were planned to be randomly assigned (1:1) after the first TACE to receive either brivanib 800 mg or placebo orally once-daily. The primary endpoint was overall survival (OS). Secondary endpoints included time to disease progression (TTDP; a composite endpoint based on development of extrahepatic spread or vascular invasion, deterioration of liver function or performance status, or death), time to extrahepatic spread or vascular invasion (TTES/VI), rate of TACE, and safety. Time to radiographic progression (TTP) and objective response rate were exploratory endpoints. The trial was terminated after randomization of 502 patients (brivanib, 249; placebo, 253) when two other phase III studies of brivanib in advanced HCC patients failed to meet OS objectives. At termination, median follow-up was approximately 16 months. Intention-to-treat analysis showed no improvement in OS with brivanib versus placebo (median, 26.4 [95% confidence interval {CI}: 19.1 to not reached] vs. 26.1 months [19.0-30.9]; hazard ratio [HR]: 0.90 [95% CI: 0.66-1.23]; log-rank P=0.5280). Brivanib improved TTES/VI (HR, 0.64 [95% CI: 0.45-0.90]), TTP (0.61 [0.48-0.77]), and rate of TACE (0.72 [0.61-0.86]), but not TTDP (0.94 [0.72-1.22]) versus placebo. Most frequent grade 3-4 adverse events included hyponatremia (brivanib, 18% vs. placebo, 5%) and hypertension (13% vs. 3%). Conclusions: In this study, brivanib as adjuvant therapy to TACE did not improve OS. (Hepatology 2014;60:1697-1707).
ISSN: 15273350
Appears in Collections:Scopus 2011-2015

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