• Naomi Kiyota, Yasuhisa Hasegawa, Shunji Takahashi, Tomoya Yokota, Chia-Jui Yen, Shigemichi Iwae, Yasushi Shimizu, Ruey-Long Hong, Masahiro Goto, Jin-Hyoung Kang, Wing Sum Kenneth Li, Robert L Ferris, Maura Gillison, Yoshinobu Namba, Manish Monga, Mark Lynch, and Makoto Tahara.
• Department of Medical Oncology and Hematology, Kobe University Hospital, Kobe, Japan; Kobe University Hospital Cancer Center, Kobe, Japan. Electronic address: nkiyota@med.kobe-u.ac.jp.
• Oral Oncol. 2017 Oct 1; 73: 138-146.

ObjectivesTo assess efficacy and safety of nivolumab versus investigator's choice of therapy (IC) in Asian patients with platinum-refractory recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).Materials And MethodsThirty-four patients from Japan, Taiwan, Hong Kong, and Korea received nivolumab 3mg/kg (n=23) every 2weeks or IC (n=11), as part of a global trial (n=361), until intolerable toxicity or disease progression. The primary endpoint was overall survival (OS).ResultsMedian OS was 9.5months (95% confidence interval [CI] 9.1-NR) with nivolumab and 6.2months (95% CI 2.6-NR) with IC. Seven (30.4%) patients receiving nivolumab and six (54.5%) receiving IC died. The hazard ratio (HR) for risk of death (nivolumab vs. IC) was 0.50 (95% CI 0.17-1.48). Median progression-free survival was 1.9months (95% CI 1.6-7.5) with nivolumab and 1.8months (95% CI 0.4-6.1) with IC (HR 0.57 [95% CI 0.25-1.33]). Objective response rates (complete+partial responses) were 26.1% (6/23 patients; 95% CI 10.2-48.4) for nivolumab and 0% (0/11 patients; 95% CI 0.0-28.5) for IC. Sixteen (69.6%) nivolumab-treated patients and 10 (90.9%) patients receiving IC had a treatment-related adverse event, most commonly decreased appetite (21.7%), pruritus, rash, and fatigue (17.4% each) with nivolumab, and nausea, stomatitis, and decreased appetite (27.3% each) with IC.ConclusionNivolumab demonstrated a survival advantage compared with conventional treatments in Asian patients with platinum-refractory recurrent or metastatic SCCHN, and was well tolerated. Clinical trial registration NCT02105636.Copyright © 2017 The Authors. Published by Elsevier Ltd.. All rights reserved.

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