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.
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Date
2019-09-01ICR Author
Author
Saba, NF
Blumenschein, G
Guigay, J
Licitra, L
Fayette, J
Harrington, KJ
Kiyota, N
Gillison, ML
Ferris, RL
Jayaprakash, V
Li, L
Brossart, P
Type
Journal Article
Metadata
Show full item recordAbstract
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.
Collections
Subject
Humans
Neoplasm Metastasis
Age Factors
Aged
Female
Male
Antineoplastic Agents, Immunological
Squamous Cell Carcinoma of Head and Neck
Nivolumab
Research team
Targeted Therapy
Language
eng
Date accepted
2019-06-13
License start date
2019-09
Citation
Oral oncology, 2019, 96 pp. 7 - 14
Publisher
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