dc.contributor.author | Saba, NF | |
dc.contributor.author | Blumenschein, G | |
dc.contributor.author | Guigay, J | |
dc.contributor.author | Licitra, L | |
dc.contributor.author | Fayette, J | |
dc.contributor.author | Harrington, KJ | |
dc.contributor.author | Kiyota, N | |
dc.contributor.author | Gillison, ML | |
dc.contributor.author | Ferris, RL | |
dc.contributor.author | Jayaprakash, V | |
dc.contributor.author | Li, L | |
dc.contributor.author | Brossart, P | |
dc.date.accessioned | 2020-06-03T10:09:36Z | |
dc.date.issued | 2019-09-01 | |
dc.identifier.citation | Oral oncology, 2019, 96 pp. 7 - 14 | |
dc.identifier.issn | 1368-8375 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/3677 | |
dc.identifier.eissn | 1879-0593 | |
dc.identifier.doi | 10.1016/j.oraloncology.2019.06.017 | |
dc.description.abstract | OBJECTIVES: Many patients with squamous cell carcinoma of the head and neck (SCCHN) are ≥65 years old; comorbidities and other age-related factors may affect their ability to tolerate traditional chemotherapy. Nivolumab is the only immunotherapy to significantly improve overall survival (OS) versus investigator's choice (IC) of single-agent chemotherapy at primary analysis in a phase 3 trial (CheckMate 141) in patients with recurrent/metastatic SCCHN post-platinum therapy. In this post hoc analysis, we report efficacy and safety by age. PATIENTS AND METHODS: Eligible patients were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks (n = 240) or IC (methotrexate, docetaxel, or cetuximab n = 121). The primary endpoint of the trial was OS. For this analysis, outcomes were analyzed by age < 65 and ≥65 years. The data cut-off date was September 2017 (minimum follow-up 24.2 months). RESULTS: At baseline, 68 patients (28.3%) receiving nivolumab and 45 patients (37.2%) receiving IC were ≥65 years. Baseline characteristics were generally similar across age groups. OS and tumor response benefits with nivolumab versus IC were maintained regardless of age. The 30-month OS rates of 11.2% (<65 years) and 13.0% (≥65 years) with nivolumab were more than tripled versus corresponding IC rates of 1.4% and 3.3%, respectively. The nivolumab arm had a lower rate of treatment-related adverse events versus IC regardless of age, consistent with the overall patient population. CONCLUSION: In CheckMate 141, nivolumab resulted in a higher survival versus IC in patients <65 and ≥65 years, with a manageable safety profile in both age groups. ClinicalTrials.gov: NCT02105636. | |
dc.format | Print-Electronic | |
dc.format.extent | 7 - 14 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | Humans | |
dc.subject | Neoplasm Metastasis | |
dc.subject | Age Factors | |
dc.subject | Aged | |
dc.subject | Female | |
dc.subject | Male | |
dc.subject | Antineoplastic Agents, Immunological | |
dc.subject | Squamous Cell Carcinoma of Head and Neck | |
dc.subject | Nivolumab | |
dc.title | Nivolumab versus investigator's choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by age. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2019-06-13 | |
rioxxterms.versionofrecord | 10.1016/j.oraloncology.2019.06.017 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by-nc-nd/4.0 | |
rioxxterms.licenseref.startdate | 2019-09 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Oral oncology | |
pubs.notes | Not 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/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 | 96 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Targeted Therapy | |
dc.contributor.icrauthor | Harrington, Kevin | |