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J Clin Oncol. 2015 Feb 20;33(6):559-66. doi: 10.1200/JCO.2013.53.7746. Epub 2014 Dec 29.

SEARCH: a phase III, randomized, double-blind, placebo-controlled trial of sorafenib plus erlotinib in patients with advanced hepatocellular carcinoma.

Author information

1
Andrew X. Zhu, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA; Olivier Rosmorduc, Service d'Hépatologie, Hôpital Saint-Antoine, Paris; Marie-Aude Leberre, Bayer HealthCare Pharmaceuticals, Loos, France; T.R. Jeffry Evans, Beatson West of Scotland Cancer Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow; Paul J. Ross, King's College Hospital, London, United Kingdom; Armando Santoro, Humanitas Cancer Center, Milan, Italy; Flair Jose Carrilho, University of São Paulo School of Medicine, São Paulo, Brazil; Jordi Bruix and Josep M. Llovet, Barcelona Clínic Liver Cancer Group, Institut d'Investigacions Biomèdiques, August Pi i Sunyer, Hospital Clínic Barcelona, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Barcelona; Josep M. Llovet, Institució Catalana de Recerca I Estudis Avançats, Catalonia, Spain; Shukui Qin, People's Liberation Army Cancer Center of Nanjing Bayi Hospital, Jiangsu, China; Paul J. Thuluvath, Institute for Digestive Health and Liver Diseases, Mercy Medical Center, Baltimore, MD; Josep M. Llovet, Mount Sinai Liver Cancer Program, Mount Sinai School of Medicine, New York, NY; Markus Jensen, Bayer Vital GmbH, Leverkusen, Germany; Gerold Meinhardt, Bayer HealthCare Pharmaceuticals, Montville, NJ; and Yoon-Koo Kang, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea. azhu@partners.org.
2
Andrew X. Zhu, Massachusetts General Hospital Cancer Center, Harvard Medical School, Boston, MA; Olivier Rosmorduc, Service d'Hépatologie, Hôpital Saint-Antoine, Paris; Marie-Aude Leberre, Bayer HealthCare Pharmaceuticals, Loos, France; T.R. Jeffry Evans, Beatson West of Scotland Cancer Centre, Institute of Cancer Sciences, University of Glasgow, Glasgow; Paul J. Ross, King's College Hospital, London, United Kingdom; Armando Santoro, Humanitas Cancer Center, Milan, Italy; Flair Jose Carrilho, University of São Paulo School of Medicine, São Paulo, Brazil; Jordi Bruix and Josep M. Llovet, Barcelona Clínic Liver Cancer Group, Institut d'Investigacions Biomèdiques, August Pi i Sunyer, Hospital Clínic Barcelona, Centro de Investigación Biomédica en Red de Enfermedades Hepáticas y Digestivas, Barcelona; Josep M. Llovet, Institució Catalana de Recerca I Estudis Avançats, Catalonia, Spain; Shukui Qin, People's Liberation Army Cancer Center of Nanjing Bayi Hospital, Jiangsu, China; Paul J. Thuluvath, Institute for Digestive Health and Liver Diseases, Mercy Medical Center, Baltimore, MD; Josep M. Llovet, Mount Sinai Liver Cancer Program, Mount Sinai School of Medicine, New York, NY; Markus Jensen, Bayer Vital GmbH, Leverkusen, Germany; Gerold Meinhardt, Bayer HealthCare Pharmaceuticals, Montville, NJ; and Yoon-Koo Kang, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Republic of Korea.

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.

PMID:
25547503
DOI:
10.1200/JCO.2013.53.7746
[Indexed for MEDLINE]
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