Please use this identifier to cite or link to this item: https://ahro.austin.org.au/austinjspui/handle/1/18446
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dc.contributor.authorWolchok, Jedd D-
dc.contributor.authorChiarion-Sileni, Vanna-
dc.contributor.authorGonzalez, Rene-
dc.contributor.authorRutkowski, Piotr-
dc.contributor.authorGrob, Jean-Jacques-
dc.contributor.authorCowey, C Lance-
dc.contributor.authorLao, Christopher D-
dc.contributor.authorWagstaff, John-
dc.contributor.authorSchadendorf, Dirk-
dc.contributor.authorFerrucci, Pier F-
dc.contributor.authorSmylie, Michael-
dc.contributor.authorDummer, Reinhard-
dc.contributor.authorHill, Andrew-
dc.contributor.authorHogg, David-
dc.contributor.authorHaanen, John-
dc.contributor.authorCarlino, Matteo S-
dc.contributor.authorBechter, Oliver-
dc.contributor.authorMaio, Michele-
dc.contributor.authorMarquez-Rodas, Ivan-
dc.contributor.authorGuidoboni, Massimo-
dc.contributor.authorMcArthur, Grant-
dc.contributor.authorLebbé, Celeste-
dc.contributor.authorAscierto, Paolo A-
dc.contributor.authorLong, Georgina V-
dc.contributor.authorCebon, Jonathan S-
dc.contributor.authorSosman, Jeffrey-
dc.contributor.authorPostow, Michael A-
dc.contributor.authorCallahan, Margaret K-
dc.contributor.authorWalker, Dana-
dc.contributor.authorRollin, Linda-
dc.contributor.authorBhore, Rafia-
dc.contributor.authorHodi, F Stephen-
dc.contributor.authorLarkin, James-
dc.date2017-09-11-
dc.date.accessioned2018-08-30T06:04:41Z-
dc.date.available2018-08-30T06:04:41Z-
dc.date.issued2017-10-05-
dc.identifier.citationThe New England Journal of Medicine 2017; 377(14): 1345-1356-
dc.identifier.urihttps://ahro.austin.org.au/austinjspui/handle/1/18446-
dc.description.abstractBACKGROUND: Nivolumab combined with ipilimumab resulted in longer progression-free survival and a higher objective response rate than ipilimumab alone in a phase 3 trial involving patients with advanced melanoma. We now report 3-year overall survival outcomes in this trial. METHODS: We randomly assigned, in a 1:1:1 ratio, patients with previously untreated advanced melanoma to receive nivolumab at a dose of 1 mg per kilogram of body weight plus ipilimumab at a dose of 3 mg per kilogram every 3 weeks for four doses, followed by nivolumab at a dose of 3 mg per kilogram every 2 weeks; nivolumab at a dose of 3 mg per kilogram every 2 weeks plus placebo; or ipilimumab at a dose of 3 mg per kilogram every 3 weeks for four doses plus placebo, until progression, the occurrence of unacceptable toxic effects, or withdrawal of consent. Randomization was stratified according to programmed death ligand 1 (PD-L1) status, BRAF mutation status, and metastasis stage. The two primary end points were progression-free survival and overall survival in the nivolumab-plus-ipilimumab group and in the nivolumab group versus the ipilimumab group. RESULTS: At a minimum follow-up of 36 months, the median overall survival had not been reached in the nivolumab-plus-ipilimumab group and was 37.6 months in the nivolumab group, as compared with 19.9 months in the ipilimumab group (hazard ratio for death with nivolumab plus ipilimumab vs. ipilimumab, 0.55 [P<0.001]; hazard ratio for death with nivolumab vs. ipilimumab, 0.65 [P<0.001]). The overall survival rate at 3 years was 58% in the nivolumab-plus-ipilimumab group and 52% in the nivolumab group, as compared with 34% in the ipilimumab group. The safety profile was unchanged from the initial report. Treatment-related adverse events of grade 3 or 4 occurred in 59% of the patients in the nivolumab-plus-ipilimumab group, in 21% of those in the nivolumab group, and in 28% of those in the ipilimumab group. CONCLUSIONS: Among patients with advanced melanoma, significantly longer overall survival occurred with combination therapy with nivolumab plus ipilimumab or with nivolumab alone than with ipilimumab alone. (Funded by Bristol-Myers Squibb and others; CheckMate 067 ClinicalTrials.gov number, NCT01844505 .).-
dc.language.isoeng-
dc.titleOverall Survival with Combined Nivolumab and Ipilimumab in Advanced Melanoma.-
dc.typeReport-
dc.typeJournal Article-
dc.identifier.journaltitleThe New England Journal of Medicine-
dc.identifier.affiliationTexas Oncology-Baylor Cancer Center, Dallasen
dc.identifier.affiliationBristol-Myers Squibb, Princeton, NJen
dc.identifier.affiliationniversity Hospitals Leuven, KU Leuven, Leuven, Belgiumen
dc.identifier.affiliationGeneral University Hospital Gregorio Marañón, Madriden
dc.identifier.affiliationNorthwestern University, Chicagoen
dc.identifier.affiliationMemorial Sloan Kettering Cancer Center and Weill Cornell Medical College, New Yorken
dc.identifier.affiliationOncology Institute of Veneto Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS), Padua, Italyen
dc.identifier.affiliationEuropean Institute of Oncology, Milan, Italyen
dc.identifier.affiliationCenter for Immuno-Oncology, University Hospital of Siena, Istituto Toscano Tumori, Siena, Italyen
dc.identifier.affiliationImmunotherapy and Somatic Cell Therapy Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori, Meldola, Italyen
dc.identifier.affiliationIstituto Nazionale Tumori Fondazione Pascale, Naples, Italyen
dc.identifier.affiliationUniversity of Michigan, Ann Arboren
dc.identifier.affiliationthe College of Medicine, Swansea University, Swansea, United Kingdomen
dc.identifier.affiliationRoyal Marsden NHS Foundation Trust, London, United Kingdomen
dc.identifier.affiliationDepartment of Dermatology, University of Essen, Essen, Germanyen
dc.identifier.affiliationGerman Cancer Consortium, Heidelberg, Germanyen
dc.identifier.affiliationCross Cancer Institute, Edmonton, AB, Canadaen
dc.identifier.affiliationPrincess Margaret Cancer Centre, Toronto, Canadaen
dc.identifier.affiliationUniversitäts Spital, Zurich, Switzerlanden
dc.identifier.affiliationTasman Oncology Research, Southport Gold Coast, QLDen
dc.identifier.affiliationCrown Princess Mary Cancer Centre, Melanoma Institute Australia, University of Sydney, Sydney, Australiaen
dc.identifier.affiliationMelanoma Institute Australia, University of Sydney, and Royal North Shore and Mater Hospitals, Sydney, Australiaen
dc.identifier.affiliationPeter MacCallum Cancer Centre, University of Melbourne, Melbourne, Australiaen
dc.identifier.affiliationOlivia Newton-John Cancer Research Institute, Heidelberg, Victoria, Australiaen
dc.identifier.affiliationUniversity of Colorado, Denveren
dc.identifier.affiliationMaria Sklodowska-Curie Institute-Oncology Center, Warsaw, Polanden
dc.identifier.affiliationAix-Marseille University, Hôpital de la Timone, Marseille, Franceen
dc.identifier.affiliationAssistance Publique-Hôpitaux de Paris, Dermatology and Centres d'Investigation Clinique, INSERM Unité 976, Hôpital Saint-Louis, Université Paris Diderot, Paris, Franceen
dc.identifier.affiliationNetherlands Cancer Institute, Amsterdamen
dc.identifier.affiliationDana-Farber Cancer Institute, Bostonen
dc.identifier.doi10.1056/NEJMoa1709684-
dc.identifier.orcid0000-0002-3898-950X-
dc.identifier.pubmedid28889792-
dc.type.austinClinical Trial, Phase III-
dc.type.austinJournal Article-
dc.type.austinMulticenter Study-
dc.type.austinRandomized Controlled Trial-
dc.type.austinResearch Support, N.I.H., Extramural-
local.name.researcherCebon, Jonathan S
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.openairecristypehttp://purl.org/coar/resource_type/c_18cf-
item.cerifentitytypePublications-
item.cerifentitytypePublications-
item.fulltextNo Fulltext-
item.grantfulltextnone-
item.languageiso639-1en-
item.openairetypeReport-
item.openairetypeJournal Article-
crisitem.author.deptOlivia Newton-John Cancer Research Institute-
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