dc.contributor.author | Ferris, RL | |
dc.contributor.author | Blumenschein, G | |
dc.contributor.author | Fayette, J | |
dc.contributor.author | Guigay, J | |
dc.contributor.author | Colevas, AD | |
dc.contributor.author | Licitra, L | |
dc.contributor.author | Harrington, K | |
dc.contributor.author | Kasper, S | |
dc.contributor.author | Vokes, EE | |
dc.contributor.author | Even, C | |
dc.contributor.author | Worden, F | |
dc.contributor.author | Saba, NF | |
dc.contributor.author | Iglesias Docampo, LC | |
dc.contributor.author | Haddad, R | |
dc.contributor.author | Rordorf, T | |
dc.contributor.author | Kiyota, N | |
dc.contributor.author | Tahara, M | |
dc.contributor.author | Monga, M | |
dc.contributor.author | Lynch, M | |
dc.contributor.author | Geese, WJ | |
dc.contributor.author | Kopit, J | |
dc.contributor.author | Shaw, JW | |
dc.contributor.author | Gillison, ML | |
dc.date.accessioned | 2017-04-05T16:05:28Z | |
dc.date.issued | 2016-11-10 | |
dc.identifier.citation | The New England journal of medicine, 2016, 375 (19), pp. 1856 - 1867 | |
dc.identifier.issn | 0028-4793 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/560 | |
dc.identifier.eissn | 1533-4406 | |
dc.identifier.doi | 10.1056/nejmoa1602252 | |
dc.description.abstract | BACKGROUND: 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.format | Print-Electronic | |
dc.format.extent | 1856 - 1867 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | MASSACHUSETTS MEDICAL SOC | |
dc.rights.uri | https://www.rioxx.net/licenses/all-rights-reserved | |
dc.subject | Humans | |
dc.subject | Carcinoma, Squamous Cell | |
dc.subject | Head and Neck Neoplasms | |
dc.subject | Neoplasm Recurrence, Local | |
dc.subject | Antineoplastic Agents | |
dc.subject | Antibodies, Monoclonal | |
dc.subject | Survival Analysis | |
dc.subject | Quality of Life | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Aged, 80 and over | |
dc.subject | Female | |
dc.subject | Male | |
dc.subject | B7-H1 Antigen | |
dc.subject | Nivolumab | |
dc.title | Nivolumab for Recurrent Squamous-Cell Carcinoma of the Head and Neck. | |
dc.type | Journal Article | |
rioxxterms.versionofrecord | 10.1056/nejmoa1602252 | |
rioxxterms.licenseref.uri | https://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2016-11 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | The New England journal of medicine | |
pubs.issue | 19 | |
pubs.notes | 6 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-status | Published | |
pubs.volume | 375 | |
pubs.embargo.terms | 6 months | |
icr.researchteam | Targeted Therapy | |
dc.contributor.icrauthor | Harrington, Kevin | |