Authors
JM Llovet, S Ricci, V Mazzaferro, P Hilgard, E Gane, JF Blanc, AC de Oliveira, A Santoro, JL Raoul, A Forner, M Schwartz, C Porta, S Zeuzem, L Bolondi, TF Greten, PR Galle, JF Seitz, I Borbath, D Haussinger, T Giannaris, M Shan, M Moscovici, D Voliotis, J Bruix
Publication date
2008
Journal
New England Journal of Medicine
Volume
359
Issue
23
Pages
378-390
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
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Scholar articles
JM Llovet, S Ricci, V Mazzaferro, P Hilgard, E Gane… - New England journal of medicine, 2008
JM Llovet, S Ricci - Hilgard P, Gane E, Blanc JF, de Oliveira AC, Santoro A …, 2008
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… - Sorafenib in advanced hepatocellular carcinoma. New …, 2008