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
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
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DOI：
10.1016/j.oraloncology.2017.07.023
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发表时间：
2017-10-01
期刊：
影响因子：
4.8
通讯作者：
Tahara, Makoto
中科院分区：
文献类型：
--
作者：
Kiyota, Naomi;Hasegawa, Yasuhisa;Tahara, Makoto
目的：评估纳武利尤单抗与研究者选择的疗法（IC）在患有铂难治性复发性或转移性头颈部鳞状细胞癌（SCCHN）的亚洲患者中的疗效和安全性。来自日本、中国台湾、中国香港和韩国的34例患者接受nivolumab 3 mg/kg（n = 23）每2周一次或IC（n = 11），作为全球试验的一部分（n = 361），直至出现不可耐受的毒性或疾病进展。主要终点是总生存期（OS）。结果：纳武单抗的中位OS为9.5个月（95%置信区间[CI] 9.1-NR），IC为6.2个月（95% CI 2.6-NR）。7例（30.4%）接受nivolumab的患者和6例（54.5%）接受IC的患者死亡。死亡风险的风险比（HR）（纳武利尤单抗vs IC）为0.50（95% CI 0.17-1.48）。纳武单抗组的中位无进展生存期为1.9个月（95% CI 1.6-7.5），IC组为1.8个月（95% CI 0.4-6.1）（HR 0.57 [95% CI 0.25-1.33]）。纳武单抗的客观缓解率（完全缓解+部分缓解）为26.1%（6/23例患者; 95% CI 10.2-48.4），IC为0%（0/11例患者; 95% CI 0.0-28.5）。十六（69.6%）nivolumab治疗患者和10例（90.9%）接受IC的患者发生了治疗相关不良事件，最常见的是食欲下降（21.7%）、瘙痒、皮疹和疲劳（各17.4%）与纳武利尤单抗、恶心、口腔炎和食欲下降结论：在患有铂难治性复发性或转移性SCCHN的亚洲患者中，与常规治疗相比，纳武利尤单抗显示出生存优势，并且耐受性良好。(C)2017作者爱思唯尔有限公司出版
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.