TY - JOUR
T1 - Sorafenib in advanced hepatocellular carcinoma
AU - Llovet, Josep M.
AU - Ricci, Sergio
AU - Mazzaferro, Vincenzo
AU - Hilgard, Philip
AU - Gane, Edward
AU - Blanc, Jean Frédéric
AU - De Oliveira, Andre Cosme
AU - Santoro, Armando
AU - Raoul, Jean Luc
AU - Forner, Alejandro
AU - Schwartz, Myron
AU - Porta, Camillo
AU - Zeuzem, Stefan
AU - Bolondi, Luigi
AU - Greten, Tim F.
AU - Galle, Peter R.
AU - Seitz, Jean François
AU - Borbath, Ivan
AU - Häussinger, Dieter
AU - Giannaris, Tom
AU - Shan, Minghua
AU - Moscovici, Marius
AU - Voliotis, Dimitris
AU - Bruix, Jordi
PY - 2008/7/24
Y1 - 2008/7/24
N2 - BACKGROUND: No effective systemic therapy exists for patients with advanced hepatocellular carcinoma. A preliminary study suggested that sorafenib, an oral multikinase inhibitor of the vascular endothelial growth factor receptor, the platelet-derived growth factor receptor, and Raf may be effective in hepatocellular carcinoma. METHODS: In this multicenter, phase 3, double-blind, placebo-controlled trial, we randomly assigned 602 patients with advanced hepatocellular carcinoma who had not received previous systemic treatment to receive either sorafenib (at a dose of 400 mg twice daily) or placebo. Primary outcomes were overall survival and the time to symptomatic progression. Secondary outcomes included the time to radiologic progression and safety. RESULTS: At the second planned interim analysis, 321 deaths had occurred, and the study was stopped. Median overall survival was 10.7 months in the sorafenib group and 7.9 months in the placebo group (hazard ratio in the sorafenib group, 0.69; 95% confidence interval, 0.55 to 0.87; P
AB - BACKGROUND: No effective systemic therapy exists for patients with advanced hepatocellular carcinoma. A preliminary study suggested that sorafenib, an oral multikinase inhibitor of the vascular endothelial growth factor receptor, the platelet-derived growth factor receptor, and Raf may be effective in hepatocellular carcinoma. METHODS: In this multicenter, phase 3, double-blind, placebo-controlled trial, we randomly assigned 602 patients with advanced hepatocellular carcinoma who had not received previous systemic treatment to receive either sorafenib (at a dose of 400 mg twice daily) or placebo. Primary outcomes were overall survival and the time to symptomatic progression. Secondary outcomes included the time to radiologic progression and safety. RESULTS: At the second planned interim analysis, 321 deaths had occurred, and the study was stopped. Median overall survival was 10.7 months in the sorafenib group and 7.9 months in the placebo group (hazard ratio in the sorafenib group, 0.69; 95% confidence interval, 0.55 to 0.87; P
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U2 - 10.1056/NEJMoa0708857
DO - 10.1056/NEJMoa0708857
M3 - Article
C2 - 18650514
AN - SCOPUS:47949116252
VL - 359
SP - 378
EP - 390
JO - New England Journal of Medicine
JF - New England Journal of Medicine
SN - 0028-4793
IS - 4
ER -