Sorafenib in advanced hepatocellular carcinoma

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 GiannarisMinghua Shan, Marius Moscovici, Dimitris Voliotis, Jordi Bruix

Research output: Contribution to journalArticlepeer-review

Abstract

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

Original languageEnglish
Pages (from-to)378-390
Number of pages13
JournalNew England Journal of Medicine
Volume359
Issue number4
DOIs
Publication statusPublished - Jul 24 2008

ASJC Scopus subject areas

  • Medicine(all)

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