Sorafenib in advanced hepatocellular carcinoma.
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Sorafenib in advanced hepatocellular carcinoma. / Llovet, Josep M; Ricci, Sergio; Mazzaferro, Vincenzo; Hilgard, Philip; Gane, Edward; Blanc, Jean-Frédéric; Oliveira, de; Cosme, Andre; Santoro, Armando; Raoul, Jean-Luc; Forner, Alejandro; Schwartz, Myron; Porta, Camillo; Zeuzem, Stefan; Bolondi, Luigi; Buggisch, Peter; Galle, Peter R; Seitz, Jean-François; Borbath, Ivan; Häussinger, Dieter; Giannaris, Tom; Shan, Minghua; Moscovici, Marius; Voliotis, Dimitris; Bruix, Jordi.
in: NEW ENGL J MED, Jahrgang 359, Nr. 4, 4, 2008, S. 378-390.Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung
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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 - Oliveira, de
AU - Cosme, Andre
AU - Santoro, Armando
AU - Raoul, Jean-Luc
AU - Forner, Alejandro
AU - Schwartz, Myron
AU - Porta, Camillo
AU - Zeuzem, Stefan
AU - Bolondi, Luigi
AU - Buggisch, Peter
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
Y1 - 2008
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
M3 - SCORING: Zeitschriftenaufsatz
VL - 359
SP - 378
EP - 390
JO - NEW ENGL J MED
JF - NEW ENGL J MED
SN - 0028-4793
IS - 4
M1 - 4
ER -