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http://hdl.handle.net/2445/117402
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DC Field | Value | Language |
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dc.contributor.author | Zhu, Andrew X. | - |
dc.contributor.author | Rosmorduc, Olivier | - |
dc.contributor.author | Evans, T.R. Jeffry | - |
dc.contributor.author | Ross, Paul J. | - |
dc.contributor.author | Santoro, Armando | - |
dc.contributor.author | Carrilho, Flair José | - |
dc.contributor.author | Bruix Tudó, Jordi | - |
dc.contributor.author | Qin, Shukui | - |
dc.contributor.author | Thuluvath, Paul J. | - |
dc.contributor.author | Llovet i Bayer, Josep Maria | - |
dc.contributor.author | Leberre, Marie-Aude | - |
dc.contributor.author | Jensen, Markus | - |
dc.contributor.author | Meinhardt, Gerold | - |
dc.contributor.author | Kang, Yoon-Koo | - |
dc.date.accessioned | 2017-11-06T10:56:54Z | - |
dc.date.available | 2017-11-06T10:56:54Z | - |
dc.date.issued | 2014-02-20 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.uri | http://hdl.handle.net/2445/117402 | - |
dc.description.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. | - |
dc.format.extent | 8 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1200/JCO.2013.53.7746 | - |
dc.relation.ispartof | Journal of Clinical Oncology, 2014, vol. 33, num. 6, p. 559-566 | - |
dc.relation.uri | https://doi.org/10.1200/JCO.2013.53.7746 | - |
dc.rights | (c) American Society of Clinical Oncology, 2014 | - |
dc.source | Articles publicats en revistes (Medicina) | - |
dc.subject.classification | Càncer de fetge | - |
dc.subject.classification | Quimioteràpia | - |
dc.subject.classification | Assaigs clínics de medicaments | - |
dc.subject.classification | Placebos | - |
dc.subject.other | Liver cancer | - |
dc.subject.other | Chemotherapy | - |
dc.subject.other | Drug testing | - |
dc.subject.other | Placebos (Medicine) | - |
dc.title | Search: A phase III, randomized, double-blind, placebo-controlled trial of sorafenib plus erlotinib in patients with advanced hepatocellular carcinoma | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.identifier.idgrec | 649304 | - |
dc.date.updated | 2017-11-06T10:56:54Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 25547503 | - |
Appears in Collections: | Articles publicats en revistes (Medicina) |
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File | Description | Size | Format | |
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649304.pdf | 165.12 kB | Adobe PDF | View/Open |
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