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dc.contributor.authorFerris, RLen_US
dc.contributor.authorBlumenschein, Gen_US
dc.contributor.authorFayette, Jen_US
dc.contributor.authorGuigay, Jen_US
dc.contributor.authorColevas, ADen_US
dc.contributor.authorLicitra, Len_US
dc.contributor.authorHarrington, KJen_US
dc.contributor.authorKasper, Sen_US
dc.contributor.authorVokes, EEen_US
dc.contributor.authorEven, Cen_US
dc.contributor.authorWorden, Fen_US
dc.contributor.authorSaba, NFen_US
dc.contributor.authorDocampo, LCIen_US
dc.contributor.authorHaddad, Ren_US
dc.contributor.authorRordorf, Ten_US
dc.contributor.authorKiyota, Nen_US
dc.contributor.authorTahara, Men_US
dc.contributor.authorLynch, Men_US
dc.contributor.authorJayaprakash, Ven_US
dc.contributor.authorLi, Len_US
dc.contributor.authorGillison, MLen_US
dc.date.accessioned2019-01-25T14:30:34Z
dc.date.issued2018-06en_US
dc.identifier.citationOral oncology, 2018, 81 pp. 45 - 51en_US
dc.identifier.issn1368-8375en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/3028
dc.identifier.eissn1879-0593en_US
dc.identifier.doi10.1016/j.oraloncology.2018.04.008en_US
dc.description.abstractOBJECTIVES:We report 2-year results from CheckMate 141 to establish the long-term efficacy and safety profile of nivolumab and outcomes by tumor PD-L1 expression in patients with recurrent or metastatic (R/M),platinum-refractory squamous cell carcinoma of the head and neck (SCCHN). METHODS:Patients with R/M SCCHN with tumor progression/recurrence within 6 months of platinum therapy were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks or investigator's choice (IC). Primary endpoint: overall survival (OS). Data cutoff: September 2017. RESULTS:With 24.2 months' minimum follow-up, nivolumab (n = 240) continued to improve OS vs IC (n = 121), hazard ratio (HR) = 0.68 (95% CI 0.54-0.86). Nivolumab nearly tripled the estimated 24-month OS rate (16.9%) vs IC (6.0%), and demonstrated OS benefit across patients with tumor PD-L1 expression ≥1% (HR [95% CI] = 0.55 [0.39-0.78]) and  < 1% (HR [95% CI] = 0.73 [0.49-1.09]), and regardless of tumor HPV status. Estimated OS rates at 18, 24, and 30 months with nivolumab were consistent irrespective of PD-L1 expression (<1%/≥1%). In the nivolumab arm, there were no observed differences in baseline characteristics or safety profile between long-term survivors and the overall population. Grade 3-4 treatment-related adverse event rates were 15.3% and 36.9% for nivolumab and IC, respectively. CONCLUSION:Nivolumab significantly improved OS at the primary analysis and demonstrated prolonged OS benefit vs IC and maintenance of a manageable and consistent safety profile with 2-year follow-up. OS benefit was observed with nivolumab irrespective of PD-L1 expression and HPV status. (Clinicaltrials.gov: NCT02105636).en_US
dc.formatPrint-Electronicen_US
dc.format.extent45 - 51en_US
dc.languageengen_US
dc.language.isoengen_US
dc.rights.urihttp://www.rioxx.net/licenses/under-embargo-all-rights-reserveden_US
dc.subjectHumansen_US
dc.subjectNeoplasm Metastasisen_US
dc.subjectNeoplasm Recurrence, Localen_US
dc.subjectSurvival Analysisen_US
dc.subjectAntineoplastic Agents, Immunologicalen_US
dc.subjectB7-H1 Antigenen_US
dc.subjectSquamous Cell Carcinoma of Head and Necken_US
dc.subjectNivolumaben_US
dc.titleNivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression.en_US
dc.typeJournal Article
dcterms.dateAccepted2018-04-10en_US
rioxxterms.versionofrecord10.1016/j.oraloncology.2018.04.008en_US
rioxxterms.licenseref.startdate2018-06en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfOral oncologyen_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/Cancer Biology
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Cancer Biology/Targeted Therapy
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Radiotherapy and Imaging/Targeted Therapy
pubs.publication-statusPublisheden_US
pubs.volume81en_US
pubs.embargo.termsNot knownen_US
icr.researchteamTargeted Therapyen_US
dc.contributor.icrauthorHarrington, Kevinen_US


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