A randomized, open-label, Phase III clinical trial of nivolumab vs. therapy of investigator's choice in recurrent squamous cell carcinoma of the head and neck: A subanalysis of Asian patients versus the global population in checkmate 141

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, Makoto Tahara

Research output: Contribution to journalArticlepeer-review

80 Scopus citations

Abstract

Objectives To 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 methods Thirty-four patients from Japan, Taiwan, Hong Kong, and Korea received nivolumab 3 mg/kg (n = 23) every 2 weeks 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). Results Median OS was 9.5 months (95% confidence interval [CI] 9.1–NR) with nivolumab and 6.2 months (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 1.9 months (95% CI 1.6–7.5) with nivolumab and 1.8 months (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. Conclusion Nivolumab 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.

Original languageEnglish (US)
Pages (from-to)138-146
Number of pages9
JournalOral Oncology
Volume73
DOIs
StatePublished - Oct 2017
Externally publishedYes

Keywords

  • Asian
  • Nivolumab
  • Programmed death-1
  • Squamous cell carcinoma of the head and neck

ASJC Scopus subject areas

  • Oral Surgery
  • Oncology
  • Cancer Research

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