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Clinical Trial
. 2008 Jul 24;359(4):378-90.
doi: 10.1056/NEJMoa0708857.

Sorafenib in advanced hepatocellular carcinoma

Josep M Llovet  1 , 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; SHARP Investigators Study Group
Collaborators, Affiliations
Free article
Clinical Trial

Sorafenib in advanced hepatocellular carcinoma

Josep M Llovet et al. N Engl J Med. .
Free article

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<0.001). There was no significant difference between the two groups in the median time to symptomatic progression (4.1 months vs. 4.9 months, respectively, P=0.77). The median time to radiologic progression was 5.5 months in the sorafenib group and 2.8 months in the placebo group (P<0.001). Seven patients in the sorafenib group (2%) and two patients in the placebo group (1%) had a partial response; no patients had a complete response. Diarrhea, weight loss, hand-foot skin reaction, and hypophosphatemia were more frequent in the sorafenib group.

Conclusions: In patients with advanced hepatocellular carcinoma, median survival and the time to radiologic progression were nearly 3 months longer for patients treated with sorafenib than for those given placebo. (ClinicalTrials.gov number, NCT00105443.)

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