期刊
ORAL ONCOLOGY
卷 73, 期 -, 页码 138-146出版社
ELSEVIER SCIENCE BV
DOI: 10.1016/j.oraloncology.2017.07.023
关键词
Nivolumab; Squamous cell carcinoma of the head and neck; Programmed death-1; Asian
资金
- ONO Pharmaceutical
- Grants-in-Aid for Scientific Research [17K11384] Funding Source: KAKEN
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. (C) 2017 The Authors. Published by Elsevier Ltd.
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