• Nabil F Saba, George Blumenschein, Joel Guigay, Lisa Licitra, Jerome Fayette, Kevin J Harrington, Naomi Kiyota, Maura L Gillison, Robert L Ferris, Vijayvel Jayaprakash, Li Li, and Peter Brossart.
• Winship Cancer Institute of Emory University, 1365-C Clifton Road NE, Atlanta, GA 30322, USA. Electronic address: nfsaba@emory.edu.
• Oral Oncol. 2019 Sep 1; 96: 7-14.

ObjectivesMany 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 MethodsEligible 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).ResultsAt 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.ConclusionIn 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.Copyright © 2019 The Authors. Published by Elsevier Ltd.. All rights reserved.

18 keywords...

hide…