Authors
Josep M Llovet, Sergio Ricci, Vincenzo Mazzaferro, Philip Hilgard, Edward Gane, Jean-Frédéric Blanc, Andre Cosme De Oliveira, Armando Santoro, Jean-Luc Raoul, Alejandro Forner, Myron Schwartz, Camillo Porta, Stefan Zeuzem, Luigi Bolondi, Tim F Greten, Peter R Galle, Jean-François Seitz, Ivan Borbath, Dieter Häussinger, Tom Giannaris, Minghua Shan, Marius Moscovici, Dimitris Voliotis, Jordi Bruix
Publication date
2008/7/24
Journal
New England journal of medicine
Volume
359
Issue
4
Pages
378-390
Publisher
Massachusetts Medical Society
Description
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 …
Total citations
Scholar articles
JM Llovet, S Ricci, V Mazzaferro, P Hilgard, E Gane… - New England journal of medicine, 2008
JM Llovet, S Ricci, V Mazzaferro, P Hilgard, E Gane… - New England Journal of Medicine, 2008