Nivolumab versus investigator's choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by age.
Nivolumab versus investigator's choice in patients with recurrent or metastatic squamous cell carcinoma of the head and neck: Efficacy and safety in CheckMate 141 by age.
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DOI：
10.1016/j.oraloncology.2019.06.017
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发表时间：
2019-09
期刊：
影响因子：
4.8
通讯作者：
Brossart P
中科院分区：
文献类型：
--
作者：
Saba NF;Blumenschein G Jr;Guigay J;Licitra L;Fayette J;Harrington KJ;Kiyota N;Gillison ML;Ferris RL;Jayaprakash V;Li L;Brossart P
许多头颈部鳞状细胞癌患者都是65岁的老年人；合并症和其他年龄相关因素可能会影响他们对传统化疗的耐受性。在第三阶段试验(Checkmate 141)中，与研究人员选择的单剂化疗相比，nivolumab是唯一一种在铂治疗后复发/转移的SCCHN患者中显著提高总存活率(OS)和研究人员选择(IC)的免疫疗法。在这项特殊分析中，我们报告了按年龄分组的疗效和安全性。符合条件的患者按2：1随机分为尼伏单抗3 mg/kg每2周(n=240)或IC(甲氨蝶呤、多西他赛或西妥昔单抗n=121)。试验的主要终点是OS。在这项分析中，结果按65岁和≥65岁进行分析。数据截止日为2017年9月(最低随访24.2个月)。基线时，接受尼伏单抗治疗的68名患者(28.3%)和接受IC治疗的45名患者(37.2%)的≥年龄为65岁。各年龄组的基线特征大体相似。使用nivolumab与IC相比，无论年龄大小，OS和肿瘤反应的益处都保持不变。尼伏单抗治疗30个月的OS率分别为11.2%(65岁)和13.0%(≥65岁)，是相应的IC率(1.4%和3.3%)的三倍多。与IC相比，nivolumab ARM的治疗相关不良事件发生率较低，与年龄无关，这与总体患者人数一致。在CHECKMATE141中，尼伏单抗在65岁和≥65岁的患者中导致比IC更高的存活率，在这两个年龄组中都有可管理的安全概况。NCT02105636。
Many patients with squamous cell carcinoma of the head and neck (SCCHN) are ≥65 years old; comorbidities and other age-related factors may affect their ability to tolerate traditional chemotherapy. Nivolumab is the only immunotherapy to significantly improve overall survival (OS) versus investigator’s choice (IC) of single-agent chemotherapy at primary analysis in a phase 3 trial (CheckMate 141) in patients with recurrent/metastatic SCCHN post-platinum therapy. In this post hoc analysis, we report efficacy and safety by age. Eligible patients were randomized 2:1 to nivolumab 3 mg/kg every 2 weeks (n = 240) or IC (methotrexate, docetaxel, or cetuximab n = 121). The primary endpoint of the trial was OS. For this analysis, outcomes were analyzed by age < 65 and ≥65 years. The data cut-off date was September 2017 (minimum follow-up 24.2 months). At baseline, 68 patients (28.3%) receiving nivolumab and 45 patients (37.2%) receiving IC were ≥65 years. Baseline characteristics were generally similar across age groups. OS and tumor response benefits with nivolumab versus IC were maintained regardless of age. The 30-month OS rates of 11.2% (< 65 years) and 13.0% (≥65 years) with nivolumab were more than tripled versus corresponding IC rates of 1.4% and 3.3%, respectively. The nivolumab arm had a lower rate of treatment-related adverse events versus IC regardless of age, consistent with the overall patient population. In CheckMate 141, nivolumab resulted in a higher survival versus IC in patients < 65 and ≥65 years, with a manageable safety profile in both age groups. NCT02105636.
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