Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression.
Nivolumab vs investigator's choice in recurrent or metastatic squamous cell carcinoma of the head and neck: 2-year long-term survival update of CheckMate 141 with analyses by tumor PD-L1 expression.
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DOI：
10.1016/j.oraloncology.2018.04.008
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发表时间：
2018-06
期刊：
影响因子：
4.8
通讯作者：
Gillison ML
中科院分区：
文献类型：
--
作者：
Ferris RL;Blumenschein G Jr;Fayette J;Guigay J;Colevas AD;Licitra L;Harrington KJ;Kasper S;Vokes EE;Even C;Worden F;Saba NF;Docampo LCI;Haddad R;Rordorf T;Kiyota N;Tahara M;Lynch M;Jayaprakash V;Li L;Gillison ML
我们报告了来自CheckMate 141的2年结果，以确定nivolumab的长期疗效和安全性特征以及肿瘤PD-L1表达在复发性或转移性（R/M）铂难治性头颈部鳞状细胞癌（SCCHN）患者中的结局。在铂类治疗的6个月内具有肿瘤进展/复发的R/M SCCHN患者以2：1随机分配至纳武单抗3 mg/kg每2周一次或研究者选择（IC）。主要终点：总生存期（OS）。数据截止日期：2017年9月。在24.2个月的最短随访期内，nivolumab（n =240）继续改善OS vs IC（n = 121），风险比（HR）= 0.68（95%CI 0.54-0.86）。与IC（6.0%）相比，Nivolumab使估计的24个月OS率（16.9%）几乎增加了两倍，并且在肿瘤PD-L1表达≥1%（HR [95% CI] = 0.55 [0.39-0.78]）和< 1%（HR [95% CI] =0.73 [0.49-1.09]）的患者中证明了OS获益，无论肿瘤HPV状态如何。无论PD-L1表达如何，nivolumab在18、24和30个月时的估计OS率均一致（< 1%/≥1%）。在纳武利尤单抗组中，长期存活者和总体人群之间的基线特征或安全性特征没有观察到差异。nivolumab和IC的3-4级治疗相关不良事件发生率分别为15.3%和36.9%。在主要分析时，Nivolumab显著改善了OS，并在2年随访中证明了OS获益相对于IC的延长，并维持了可管理和一致的安全性特征。无论PD-L1表达和HPV状态如何，nivolumab均观察到OS获益。（Clinicaltrials.gov：）
We report 2-year results from CheckMate 141 to establish the long-term efficacy and safety profile of nivolumab and outcomes by tumor PD-L1 expression in patients with recurrent or metastatic (R/M),platinum-refractory squamous cell carcinoma of the head and neck (SCCHN). Patients with R/M SCCHN with tumor progression/recurrence within 6 months of platinum therapy were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks or investigator’s choice (IC). Primary endpoint: overall survival (OS). Data cutoff: September 2017. With 24.2 months’ minimum follow-up, nivolumab (n =240) continued to improve OS vs IC (n = 121), hazard ratio (HR) = 0.68 (95% CI 0.54–0.86). Nivolumab nearly tripled the estimated 24-month OS rate (16.9%) vs IC (6.0%), and demonstrated OS benefit across patients with tumor PD-L1 expression ≥1% (HR [95% CI] = 0.55 [0.39–0.78]) and < 1% (HR [95% CI] =0.73 [0.49–1.09]), and regardless of tumor HPV status. Estimated OS rates at 18, 24, and 30 months with nivolumab were consistent irrespective of PD-L1 expression (< 1%/≥1%). In the nivolumab arm, there were no observed differences in baseline characteristics or safety profile between long-term survivors and the overall population. Grade 3–4 treatment-related adverse event rates were 15.3% and 36.9% for nivolumab and IC, respectively. Nivolumab significantly improved OS at the primary analysis and demonstrated prolonged OS benefit vs IC and maintenance of a manageable and consistent safety profile with 2-year follow-up. OS benefit was observed with nivolumab irrespective of PD-L1 expression and HPV status. (Clinicaltrials.gov: )
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影响因子：
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影响因子：
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Harrington KJ;Ferris RL;Blumenschein G Jr;Colevas AD;Fayette J;Licitra L;Kasper S;Even C;Vokes EE;Worden F;Saba NF;Kiyota N;Haddad R;Tahara M;Grünwald V;Shaw JW;Monga M;Lynch M;Taylor F;DeRosa M;Morrissey L;Cocks K;Gillison ML;Guigay J
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