Show simple item record

dc.contributor.authorSchadendorf, D
dc.contributor.authorWolchok, JD
dc.contributor.authorHodi, FS
dc.contributor.authorChiarion-Sileni, V
dc.contributor.authorGonzalez, R
dc.contributor.authorRutkowski, P
dc.contributor.authorGrob, J-J
dc.contributor.authorCowey, CL
dc.contributor.authorLao, CD
dc.contributor.authorChesney, J
dc.contributor.authorRobert, C
dc.contributor.authorGrossmann, K
dc.contributor.authorMcDermott, D
dc.contributor.authorWalker, D
dc.contributor.authorBhore, R
dc.contributor.authorLarkin, J
dc.contributor.authorPostow, MA
dc.date.accessioned2018-03-05T16:19:51Z
dc.date.issued2017-12
dc.identifier.citationJournal of clinical oncology : official journal of the American Society of Clinical Oncology, 2017, 35 (34), pp. 3807 - 3814
dc.identifier.issn0732-183X
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/1565
dc.identifier.eissn1527-7755
dc.identifier.doi10.1200/jco.2017.73.2289
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.
dc.formatPrint-Electronic
dc.format.extent3807 - 3814
dc.languageeng
dc.language.isoeng
dc.subjectHumans
dc.subjectMelanoma
dc.subjectSkin Neoplasms
dc.subjectNeoplasm Invasiveness
dc.subjectAntibodies, Monoclonal
dc.subjectNeoplasm Staging
dc.subjectPrognosis
dc.subjectDisease-Free Survival
dc.subjectTreatment Outcome
dc.subjectDrug Therapy, Combination
dc.subjectWithholding Treatment
dc.subjectDrug Administration Schedule
dc.subjectProportional Hazards Models
dc.subjectStatistics, Nonparametric
dc.subjectSurvival Analysis
dc.subjectRetrospective Studies
dc.subjectDose-Response Relationship, Drug
dc.subjectDatabases, Factual
dc.subjectFemale
dc.subjectMale
dc.subjectRandomized Controlled Trials as Topic
dc.subjectClinical Trials, Phase II as Topic
dc.subjectClinical Trials, Phase III as Topic
dc.subjectKaplan-Meier Estimate
dc.subjectPatient Safety
dc.subjectIpilimumab
dc.subjectNivolumab
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.
dc.typeJournal Article
rioxxterms.versionofrecord10.1200/jco.2017.73.2289
rioxxterms.licenseref.startdate2017-12
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfJournal of clinical oncology : official journal of the American Society of Clinical Oncology
pubs.issue34
pubs.notesNot known
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.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-statusPublished
pubs.volume35
pubs.embargo.termsNot known
icr.researchteamMelanoma and Kidney Canceren_US
dc.contributor.icrauthorLarkin, Jamesen
dc.contributor.icrauthorMarsden,en


Files in this item

Thumbnail

This item appears in the following collection(s)

Show simple item record