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dc.contributor.authorFerris, RL
dc.contributor.authorBlumenschein, G
dc.contributor.authorFayette, J
dc.contributor.authorGuigay, J
dc.contributor.authorColevas, AD
dc.contributor.authorLicitra, L
dc.contributor.authorHarrington, K
dc.contributor.authorKasper, S
dc.contributor.authorVokes, EE
dc.contributor.authorEven, C
dc.contributor.authorWorden, F
dc.contributor.authorSaba, NF
dc.contributor.authorIglesias Docampo, LC
dc.contributor.authorHaddad, R
dc.contributor.authorRordorf, T
dc.contributor.authorKiyota, N
dc.contributor.authorTahara, M
dc.contributor.authorMonga, M
dc.contributor.authorLynch, M
dc.contributor.authorGeese, WJ
dc.contributor.authorKopit, J
dc.contributor.authorShaw, JW
dc.contributor.authorGillison, ML
dc.date.accessioned2017-04-05T16:05:28Z
dc.date.issued2016-11
dc.identifier.citationThe New England journal of medicine, 2016, 375 (19), pp. 1856 - 1867
dc.identifier.issn0028-4793
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/560
dc.identifier.eissn1533-4406
dc.identifier.doi10.1056/nejmoa1602252
dc.description.abstractBackground Patients with recurrent or metastatic squamous-cell carcinoma of the head and neck after platinum chemotherapy have a very poor prognosis and limited therapeutic options. Nivolumab, an anti-programmed death 1 (PD-1) monoclonal antibody, was assessed as treatment for this condition.Methods In this randomized, open-label, phase 3 trial, we assigned, in a 2:1 ratio, 361 patients with recurrent squamous-cell carcinoma of the head and neck whose disease had progressed within 6 months after platinum-based chemotherapy to receive nivolumab (at a dose of 3 mg per kilogram of body weight) every 2 weeks or standard, single-agent systemic therapy (methotrexate, docetaxel, or cetuximab). The primary end point was overall survival. Additional end points included progression-free survival, rate of objective response, safety, and patient-reported quality of life.Results The median overall survival was 7.5 months (95% confidence interval [CI], 5.5 to 9.1) in the nivolumab group versus 5.1 months (95% CI, 4.0 to 6.0) in the group that received standard therapy. Overall survival was significantly longer with nivolumab than with standard therapy (hazard ratio for death, 0.70; 97.73% CI, 0.51 to 0.96; P=0.01), and the estimates of the 1-year survival rate were approximately 19 percentage points higher with nivolumab than with standard therapy (36.0% vs. 16.6%). The median progression-free survival was 2.0 months (95% CI, 1.9 to 2.1) with nivolumab versus 2.3 months (95% CI, 1.9 to 3.1) with standard therapy (hazard ratio for disease progression or death, 0.89; 95% CI, 0.70 to 1.13; P=0.32). The rate of progression-free survival at 6 months was 19.7% with nivolumab versus 9.9% with standard therapy. The response rate was 13.3% in the nivolumab group versus 5.8% in the standard-therapy group. Treatment-related adverse events of grade 3 or 4 occurred in 13.1% of the patients in the nivolumab group versus 35.1% of those in the standard-therapy group. Physical, role, and social functioning was stable in the nivolumab group, whereas it was meaningfully worse in the standard-therapy group.Conclusions Among patients with platinum-refractory, recurrent squamous-cell carcinoma of the head and neck, treatment with nivolumab resulted in longer overall survival than treatment with standard, single-agent therapy. (Funded by Bristol-Myers Squibb; CheckMate 141 ClinicalTrials.gov number, NCT02105636 .).
dc.formatPrint-Electronic
dc.format.extent1856 - 1867
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://www.rioxx.net/licenses/all-rights-reserved
dc.subjectHumans
dc.subjectCarcinoma, Squamous Cell
dc.subjectHead and Neck Neoplasms
dc.subjectNeoplasm Recurrence, Local
dc.subjectAntineoplastic Agents
dc.subjectAntibodies, Monoclonal
dc.subjectSurvival Analysis
dc.subjectQuality of Life
dc.subjectAdult
dc.subjectAged
dc.subjectAged, 80 and over
dc.subjectFemale
dc.subjectMale
dc.subjectB7-H1 Antigen
dc.subjectNivolumab
dc.titleNivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck.
dc.typeJournal Article
rioxxterms.versionofrecord10.1056/nejmoa1602252
rioxxterms.licenseref.urihttps://www.rioxx.net/licenses/all-rights-reserved
rioxxterms.licenseref.startdate2016-11
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfThe New England journal of medicine
pubs.issue19
pubs.notes6 months
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.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-statusPublished
pubs.volume375en_US
pubs.embargo.terms6 months
icr.researchteamTargeted Therapyen_US
dc.contributor.icrauthorHarrington, Kevinen


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