Please use this identifier to cite or link to this item: http://hdl.handle.net/2445/117402
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dc.contributor.authorZhu, Andrew X.-
dc.contributor.authorRosmorduc, Olivier-
dc.contributor.authorEvans, T.R. Jeffry-
dc.contributor.authorRoss, Paul J.-
dc.contributor.authorSantoro, Armando-
dc.contributor.authorCarrilho, Flair José-
dc.contributor.authorBruix Tudó, Jordi-
dc.contributor.authorQin, Shukui-
dc.contributor.authorThuluvath, Paul J.-
dc.contributor.authorLlovet i Bayer, Josep Maria-
dc.contributor.authorLeberre, Marie-Aude-
dc.contributor.authorJensen, Markus-
dc.contributor.authorMeinhardt, Gerold-
dc.contributor.authorKang, Yoon-Koo-
dc.date.accessioned2017-11-06T10:56:54Z-
dc.date.available2017-11-06T10:56:54Z-
dc.date.issued2014-02-20-
dc.identifier.issn0732-183X-
dc.identifier.urihttp://hdl.handle.net/2445/117402-
dc.description.abstractPURPOSE: 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.extent8 p.-
dc.format.mimetypeapplication/pdf-
dc.language.isoeng-
dc.publisherAmerican Society of Clinical Oncology-
dc.relation.isformatofReproducció del document publicat a: https://doi.org/10.1200/JCO.2013.53.7746-
dc.relation.ispartofJournal of Clinical Oncology, 2014, vol. 33, num. 6, p. 559-566-
dc.relation.urihttps://doi.org/10.1200/JCO.2013.53.7746-
dc.rights(c) American Society of Clinical Oncology, 2014-
dc.sourceArticles publicats en revistes (Medicina)-
dc.subject.classificationCàncer de fetge-
dc.subject.classificationQuimioteràpia-
dc.subject.classificationAssaigs clínics de medicaments-
dc.subject.classificationPlacebos-
dc.subject.otherLiver cancer-
dc.subject.otherChemotherapy-
dc.subject.otherDrug testing-
dc.subject.otherPlacebos (Medicine)-
dc.titleSearch: A phase III, randomized, double-blind, placebo-controlled trial of sorafenib plus erlotinib in patients with advanced hepatocellular carcinoma-
dc.typeinfo:eu-repo/semantics/article-
dc.typeinfo:eu-repo/semantics/publishedVersion-
dc.identifier.idgrec649304-
dc.date.updated2017-11-06T10:56:54Z-
dc.rights.accessRightsinfo:eu-repo/semantics/openAccess-
dc.identifier.pmid25547503-
Appears in Collections:Articles publicats en revistes (Medicina)

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