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美国和德国复发性/转移性头颈部鳞状细胞癌患者接受纳武利尤单抗治疗的汇总分析。

Pooled analysis of nivolumab treatment in patients with recurrent/metastatic squamous cell carcinoma of the head and neck in the United States and Germany.

机构信息

Health Economics Outcomes Research, Bristol Myers Squibb, Lawrenceville, New Jersey, USA.

Medical Oncology, Bristol Myers Squibb GmbH & Co. KGaA, Munich, Germany.

出版信息

Head Neck. 2021 Nov;43(11):3540-3551. doi: 10.1002/hed.26853. Epub 2021 Sep 6.

Abstract

BACKGROUND

In the Phase-III clinical trial, CheckMate 141, nivolumab significantly improved survival versus standard of care in patients with platinum-refractory recurrent/metastatic squamous cell carcinoma of the head and neck (R/M SCCHN).

METHODS

This pooled analysis investigated the real-world effectiveness of nivolumab, following prior platinum-based therapy, in patients with R/M SCCHN from the United States (US) Flatiron Health database and German HANNA prospective observational study.

RESULTS

Overall, 782 patients (56% US; 44% Germany) were included. Median overall survival (OS) was 8.71 months, and progression-free survival was 4.11 months. Eastern Cooperative Oncology Group Performance Status 0 or 1, platinum sensitivity, and older age were associated with longer OS, in which number of prior lines of therapy had no significant effect.

CONCLUSION

These findings demonstrate survival benefits of nivolumab in patients with R/M SCCHN in the real-world setting. The observed real-world effectiveness of nivolumab aligns with the efficacy of nivolumab in CheckMate 141.

摘要

背景

在三期临床试验 CheckMate 141 中,纳武利尤单抗对比标准治疗显著改善了铂类难治性复发性/转移性头颈部鳞状细胞癌(R/M SCCHN)患者的总生存期。

方法

本汇总分析调查了先前接受铂类治疗后的纳武利尤单抗在来自美国 Flatiron Health 数据库和德国 HANNA 前瞻性观察性研究的 R/M SCCHN 患者中的真实世界疗效。

结果

总体而言,纳入了 782 名患者(56%来自美国;44%来自德国)。中位总生存期(OS)为 8.71 个月,无进展生存期为 4.11 个月。东部肿瘤协作组体力状态 0 或 1、铂类敏感性和年龄较大与更长的 OS 相关,其中先前治疗线数无显著影响。

结论

这些发现表明,纳武利尤单抗在真实世界环境中为 R/M SCCHN 患者带来了生存获益。观察到的纳武利尤单抗的真实世界疗效与 CheckMate 141 中的纳武利尤单抗疗效一致。

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