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dc.contributor.authorSpigel, David R
dc.contributor.authorEdelman, Martin J
dc.contributor.authorO'Byrne, Kenneth
dc.contributor.authorPaz Ares, Luis Gonzaga 
dc.contributor.authorMocci, Simonetta
dc.contributor.authorPhan, See
dc.contributor.authorShames, David S
dc.contributor.authorSmith, Dustin
dc.contributor.authorYu, Wei
dc.contributor.authorPaton, Virginia E
dc.contributor.authorMok, Tony
dc.date.accessioned2019-09-27T08:10:04Z
dc.date.available2019-09-27T08:10:04Z
dc.date.issued2017-02
dc.identifier.citationJ Clin Oncol. 2017;35(4):412-420.es_ES
dc.identifier.issn0732-183Xes_ES
dc.identifier.urihttp://hdl.handle.net/20.500.12105/8385
dc.description.abstractPurpose The phase III OAM4971g study (METLung) examined the efficacy and safety of onartuzumab plus erlotinib in patients with locally advanced or metastatic non-small-cell lung cancer selected by MET immunohistochemistry whose disease had progressed after treatment with a platinum-based chemotherapy regimen. Patients and Methods Patients were randomly assigned at a one-to-one ratio to receive onartuzumab (15 mg/kg intravenously on day 1 of each 21-day cycle) plus daily oral erlotinib 150 mg or intravenous placebo plus daily oral erlotinib 150 mg. The primary end point was overall survival (OS) in the intent-to-treat population. Secondary end points included median progression-free survival, overall response rate, biomarker analysis, and safety. Results A total of 499 patients were enrolled (onartuzumab, n = 250; placebo, n = 249). Median OS was 6.8 versus 9.1 months for onartuzumab versus placebo (stratified hazard ratio [HR], 1.27; 95% CI, 0.98 to 1.65; P = .067), with a greater number of deaths in the onartuzumab arm (130 [52%] v 114 [46%]). Median progression-free survival was 2.7 versus 2.6 months (stratified HR, 0.99; 95% CI, 0.81 to 1.20; P = .92), and overall response rate was 8.4% and 9.6% for onartuzumab versus placebo, respectively. Exploratory analyses using MET fluorescence in situ hybridization status and gene expression showed no benefit for onartuzumab; patients with EGFR mutations showed a trend toward shorter OS with onartuzumab treatment (HR, 4.68; 95% CI, 0.97 to 22.63). Grade 3 to 5 adverse events were reported by 56.0% and 51.2% of patients, with serious AEs in 33.9% and 30.7%, for experimental versus control arms, respectively. Conclusion Onartuzumab plus erlotinib did not improve clinical outcomes, with shorter OS in the onartuzumab arm, compared with erlotinib in patients with MET-positive non-small-cell lung cancer.es_ES
dc.language.isoenges_ES
dc.publisherAmerican Society of Clinical Oncology (ASCO) es_ES
dc.type.hasVersionVoRes_ES
dc.rights.urihttp://creativecommons.org/licenses/by-nc-sa/4.0/*
dc.subject.meshAdministration, Intravenouses_ES
dc.subject.meshAdministration, Orales_ES
dc.subject.meshAdult es_ES
dc.subject.meshAged es_ES
dc.subject.meshAged, 80 and over es_ES
dc.subject.meshAntibodies, Monoclonal es_ES
dc.subject.meshAntineoplastic Combined Chemotherapy Protocols es_ES
dc.subject.meshCarcinoma, Non-Small-Cell Lung es_ES
dc.subject.meshDisease-Free Survival es_ES
dc.subject.meshDrug Administration Schedule es_ES
dc.subject.meshErlotinib Hydrochloride es_ES
dc.subject.meshFemale es_ES
dc.subject.meshHumans es_ES
dc.subject.meshKaplan-Meier Estimate es_ES
dc.subject.meshLung Neoplasms es_ES
dc.subject.meshMale es_ES
dc.subject.meshMiddle Aged es_ES
dc.subject.meshNeoplasm Staging es_ES
dc.subject.meshProtein Kinase Inhibitors es_ES
dc.subject.meshYoung Adult es_ES
dc.titleResults From the Phase III Randomized Trial of Onartuzumab Plus Erlotinib Versus Erlotinib in Previously Treated Stage IIIB or IV Non-Small-Cell Lung Cancer: METLunges_ES
dc.typejournal articlees_ES
dc.rights.licenseAtribución-NoComercial-CompartirIgual 4.0 Internacional*
dc.identifier.pubmedID27937096es_ES
dc.format.volume35es_ES
dc.format.number4es_ES
dc.format.page412-420es_ES
dc.identifier.doi10.1200/JCO.2016.69.2160es_ES
dc.contributor.funderHoffmann-La Roche 
dc.description.peerreviewedes_ES
dc.identifier.e-issn1527-7755es_ES
dc.relation.publisherversionhttps://doi.org/10.1200/JCO.2016.69.2160.es_ES
dc.identifier.journalJournal of clinical oncology : official journal of the American Society of Clinical Oncologyes_ES
dc.repisalud.institucionCNIOes_ES
dc.repisalud.orgCNIOCNIO::Unidades técnicas::Unidad de Investigación Clínica de Cáncer Pulmón H12O-CNIOes_ES
dc.rights.accessRightsopen accesses_ES


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