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dc.contributor.authorEggermont, AMM
dc.contributor.authorBlank, CU
dc.contributor.authorMandala, M
dc.contributor.authorLong, GV
dc.contributor.authorAtkinson, V
dc.contributor.authorDalle, S
dc.contributor.authorHaydon, A
dc.contributor.authorLichinitser, M
dc.contributor.authorKhattak, A
dc.contributor.authorCarlino, MS
dc.contributor.authorSandhu, S
dc.contributor.authorLarkin, J
dc.contributor.authorPuig, S
dc.contributor.authorAscierto, PA
dc.contributor.authorRutkowski, P
dc.contributor.authorSchadendorf, D
dc.contributor.authorKoornstra, R
dc.contributor.authorHernandez-Aya, L
dc.contributor.authorMaio, M
dc.contributor.authorvan den Eertwegh, AJM
dc.contributor.authorGrob, J-J
dc.contributor.authorGutzmer, R
dc.contributor.authorJamal, R
dc.contributor.authorLorigan, P
dc.contributor.authorIbrahim, N
dc.contributor.authorMarreaud, S
dc.contributor.authorvan Akkooi, ACJ
dc.contributor.authorSuciu, S
dc.contributor.authorRobert, C
dc.date.accessioned2021-03-10T10:26:08Z
dc.date.available2021-03-10T10:26:08Z
dc.identifier.citationThe New England journal of medicine, 2018, 378 (19), pp. 1789 - 1801
dc.identifier.issn0028-4793
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/4410
dc.identifier.eissn1533-4406
dc.identifier.doi10.1056/nejmoa1802357
dc.description.abstractBACKGROUND:The programmed death 1 (PD-1) inhibitor pembrolizumab has been found to prolong progression-free and overall survival among patients with advanced melanoma. We conducted a phase 3 double-blind trial to evaluate pembrolizumab as adjuvant therapy in patients with resected, high-risk stage III melanoma. METHODS:Patients with completely resected stage III melanoma were randomly assigned (with stratification according to cancer stage and geographic region) to receive 200 mg of pembrolizumab (514 patients) or placebo (505 patients) intravenously every 3 weeks for a total of 18 doses (approximately 1 year) or until disease recurrence or unacceptable toxic effects occurred. Recurrence-free survival in the overall intention-to-treat population and in the subgroup of patients with cancer that was positive for the PD-1 ligand (PD-L1) were the primary end points. Safety was also evaluated. RESULTS:At a median follow-up of 15 months, pembrolizumab was associated with significantly longer recurrence-free survival than placebo in the overall intention-to-treat population (1-year rate of recurrence-free survival, 75.4% [95% confidence interval {CI}, 71.3 to 78.9] vs. 61.0% [95% CI, 56.5 to 65.1]; hazard ratio for recurrence or death, 0.57; 98.4% CI, 0.43 to 0.74; P<0.001) and in the subgroup of 853 patients with PD-L1-positive tumors (1-year rate of recurrence-free survival, 77.1% [95% CI, 72.7 to 80.9] in the pembrolizumab group and 62.6% [95% CI, 57.7 to 67.0] in the placebo group; hazard ratio, 0.54; 95% CI, 0.42 to 0.69; P<0.001). Adverse events of grades 3 to 5 that were related to the trial regimen were reported in 14.7% of the patients in the pembrolizumab group and in 3.4% of patients in the placebo group. There was one treatment-related death due to myositis in the pembrolizumab group. CONCLUSIONS:As adjuvant therapy for high-risk stage III melanoma, 200 mg of pembrolizumab administered every 3 weeks for up to 1 year resulted in significantly longer recurrence-free survival than placebo, with no new toxic effects identified. (Funded by Merck; ClinicalTrials.gov number, NCT02362594 ; EudraCT number, 2014-004944-37 .).
dc.formatPrint-Electronic
dc.format.extent1789 - 1801
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://www.rioxx.net/licenses/all-rights-reserved
dc.subjectHumans
dc.subjectMelanoma
dc.subjectSkin Neoplasms
dc.subjectNeoplasm Recurrence, Local
dc.subjectAdjuvants, Immunologic
dc.subjectNeoplasm Staging
dc.subjectDisease-Free Survival
dc.subjectInfusions, Intravenous
dc.subjectSurvival Rate
dc.subjectDouble-Blind Method
dc.subjectQuality of Life
dc.subjectAdult
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectMale
dc.subjectIntention to Treat Analysis
dc.subjectKaplan-Meier Estimate
dc.subjectAntibodies, Monoclonal, Humanized
dc.subjectB7-H1 Antigen
dc.titleAdjuvant Pembrolizumab versus Placebo in Resected Stage III Melanoma.
dc.typeJournal Article
dcterms.dateAccepted2018-04-15
rioxxterms.versionVoR
rioxxterms.versionofrecord10.1056/nejmoa1802357
rioxxterms.licenseref.urihttps://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfThe New England journal of medicine
pubs.issue19
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.volume378
pubs.embargo.termsNot known
icr.researchteamMelanoma and Kidney Cancer
icr.researchteamMelanoma and Kidney Canceren_US
dc.contributor.icrauthorLarkin, Jamesen


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