Show simple item record

dc.contributor.authorSchadendorf, Den_US
dc.contributor.authorWolchok, JDen_US
dc.contributor.authorHodi, FSen_US
dc.contributor.authorChiarion-Sileni, Ven_US
dc.contributor.authorGonzalez, Ren_US
dc.contributor.authorRutkowski, Pen_US
dc.contributor.authorGrob, J-Jen_US
dc.contributor.authorCowey, CLen_US
dc.contributor.authorLao, CDen_US
dc.contributor.authorChesney, Jen_US
dc.contributor.authorRobert, Cen_US
dc.contributor.authorGrossmann, Ken_US
dc.contributor.authorMcDermott, Den_US
dc.contributor.authorWalker, Den_US
dc.contributor.authorBhore, Ren_US
dc.contributor.authorLarkin, Jen_US
dc.contributor.authorPostow, MAen_US
dc.coverage.spatialUnited Statesen_US
dc.date.accessioned2018-03-05T16:19:51Z
dc.date.issued2017-12-01en_US
dc.identifierhttps://www.ncbi.nlm.nih.gov/pubmed/28841387en_US
dc.identifier.citationJ Clin Oncol, 2017, 35 (34), pp. 3807 - 3814en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/1565
dc.identifier.eissn1527-7755en_US
dc.identifier.doi10.1200/JCO.2017.73.2289en_US
dc.description.abstractPurpose Approximately 40% of patients with advanced melanoma who received nivolumab combined with ipilimumab in clinical trials discontinued treatment because of adverse events (AEs). We conducted a retrospective analysis to assess the efficacy and safety of nivolumab plus ipilimumab in patients who discontinued treatment because of AEs. Methods Data were pooled from phase II and III trials of patients who received nivolumab 1 mg/kg plus ipilimumab 3 mg/kg, every 3 weeks for four doses, followed by nivolumab monotherapy 3 mg/kg every 2 weeks (N = 409). Efficacy was assessed in all randomly assigned patients who discontinued because of AEs during the induction phase (n = 96) and in those who did not discontinue because of AEs (n = 233). Safety was assessed in treated patients who discontinued because of AEs (n = 176) at any time and in those who did not discontinue because of AEs (n = 231). Results At a minimum follow-up of 18 months, median progression-free survival was 8.4 months for patients who discontinued treatment because of AEs during the induction phase and 10.8 months for patients who did not discontinue because of AEs ( P = .97). Median overall survival had not been reached in either group ( P = .23). The objective response rate was 58.3% for patients who discontinued because of AEs during the induction phase and 50.2% for patients who did not discontinue. The vast majority of grade 3 or 4 AEs occurred during the induction phase, with most resolving after appropriate management. Conclusion Efficacy outcomes seemed similar between patients who discontinued nivolumab plus ipilimumab treatment because of AEs during the induction phase and those who did not discontinue because of AEs. Therefore, even after discontinuation, many patients may continue to derive benefit from combination therapy.en_US
dc.format.extent3807 - 3814en_US
dc.languageengen_US
dc.language.isoengen_US
dc.subjectAntibodies, Monoclonalen_US
dc.subjectClinical Trials, Phase II as Topicen_US
dc.subjectClinical Trials, Phase III as Topicen_US
dc.subjectDatabases, Factualen_US
dc.subjectDisease-Free Survivalen_US
dc.subjectDose-Response Relationship, Drugen_US
dc.subjectDrug Administration Scheduleen_US
dc.subjectDrug Therapy, Combinationen_US
dc.subjectFemaleen_US
dc.subjectHumansen_US
dc.subjectIpilimumaben_US
dc.subjectKaplan-Meier Estimateen_US
dc.subjectMaleen_US
dc.subjectMelanomaen_US
dc.subjectNeoplasm Invasivenessen_US
dc.subjectNeoplasm Stagingen_US
dc.subjectNivolumaben_US
dc.subjectPatient Safetyen_US
dc.subjectPrognosisen_US
dc.subjectProportional Hazards Modelsen_US
dc.subjectRandomized Controlled Trials as Topicen_US
dc.subjectRetrospective Studiesen_US
dc.subjectSkin Neoplasmsen_US
dc.subjectStatistics, Nonparametricen_US
dc.subjectSurvival Analysisen_US
dc.subjectTreatment Outcomeen_US
dc.subjectWithholding Treatmenten_US
dc.titleEfficacy and Safety Outcomes in Patients With Advanced Melanoma Who Discontinued Treatment With Nivolumab and Ipilimumab Because of Adverse Events: A Pooled Analysis of Randomized Phase II and III Trials.en_US
dc.typeJournal Article
rioxxterms.versionofrecord10.1200/JCO.2017.73.2289en_US
rioxxterms.licenseref.startdate2017-12-01en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfJ Clin Oncolen_US
pubs.issue34en_US
pubs.notesNot knownen_US
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Clinical Studies/Melanoma and Kidney Cancer/Melanoma and Kidney Cancer (hon.)
pubs.organisational-group/ICR/Primary Group/Royal Marsden Clinical Units
pubs.publication-statusPublisheden_US
pubs.volume35en_US
pubs.embargo.termsNot knownen_US
icr.researchteamMelanoma and Kidney Canceren_US
dc.contributor.icrauthorLarkin, Jamesen_US
dc.contributor.icrauthorMarsden,en_US


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record