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Title: Search: A phase III, randomized, double-blind, placebo-controlled trial of sorafenib plus erlotinib in patients with advanced hepatocellular carcinoma
Author: Zhu, Andrew X.
Rosmorduc, Olivier
Evans, T.R. Jeffry
Ross, Paul J.
Santoro, Armando
Carrilho, Flair Jose
Bruix Tudó, Jordi
Qin, Shukui
Thuluvath, Paul J.
Llovet i Bayer, Josep Maria
Leberre, Marie-Aude
Jensen, Markus
Meinhardt, Gerold
Kang, Yoon-Koo
Keywords: Càncer de fetge
Assaigs clínics de medicaments
Liver cancer
Drug testing
Placebos (Medicine)
Issue Date: 20-Feb-2014
Publisher: American Society of Clinical Oncology
Abstract: PURPOSE: To compare the clinical outcomes of sorafenib plus either erlotinib or placebo in patients with advanced hepatocellular carcinoma (HCC) in a multicenter, multinational, randomized, phase III trial. PATIENTS AND METHODS: Patients with advanced HCC and underlying Child-Pugh class A cirrhosis, who were naive to systemic treatment (N = 720), were randomly assigned to sorafenib plus either erlotinib (n = 362) or placebo (n = 358). The primary end point was overall survival (OS). RESULTS: Median OS was similar in the sorafenib plus erlotinib and sorafenib plus placebo groups (9.5 v 8.5 months, respectively; hazard ratio [HR], 0.929; P = .408), as was median time to progression (3.2 v 4.0 months, respectively; HR, 1.135; P = .18). In the sorafenib/erlotinib arm versus the sorafenib/placebo arm, the overall response rate trended higher (6.6% v 3.9%, respectively; P = .102), whereas the disease control rate was significantly lower (43.9% v 52.5%, respectively; P = .021). The median durations of treatment with sorafenib were 86 days in the sorafenib/erlotinib arm and 123 days in the sorafenib/placebo arm. In the sorafenib/erlotinib and sorafenib/placebo arms, the rates of treatment-emergent serious AEs (58.0% v 54.6%, respectively) and drug-related serious AEs (21.0% v 22.8%, respectively) were similar. AEs matched the known safety profiles of both agents, but rates of rash/desquamation, anorexia, and diarrhea were higher in the sorafenib/erlotinib arm, whereas rates of alopecia and hand-foot skin reaction were higher in the sorafenib/placebo arm. Withdrawal rates for AEs during cycles 1 to 3 were higher in the sorafenib/erlotinib arm. CONCLUSION: Adding erlotinib to sorafenib did not improve survival in patients with advanced HCC.
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It is part of: Journal of Clinical Oncology, 2014, vol. 33, num. 6, p. 559-566
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ISSN: 0732-183X
Appears in Collections:Articles publicats en revistes (Medicina)

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