Background:

Pembrolizumab, a humanized immunoglobulin monoclonal antibody directed against the programmed cell death 1 receptor, demonstrated robust efficacy and a manageable safety profile across multiple tumor types in clinical trials.

Aim:

To investigate the efficacy and safety of first-line pembrolizumab for patients with non-small cell lung cancers (NSCLCs) in clinical practice.

Methods:

In this observational monocentric retrospective study, 38 patients with PD-L1 >50% were enrolled between November 2017 and November 2018.

Results:

The global median overall survival was 11.08 months (95% confidence interval [CI], 5.98–not reached) and the global median progression-free survival was 6 months (95% CI, 3–not reached). In the univariate analysis, clinical performance status score and the development of immune-related adverse events were the only 2 clinical factors significantly correlated with overall survival.

Conclusion:

The results of the present study suggest that pembrolizumab seems less effective in the real-life population than in the pivotal clinical trials in patients with NSCLC but remains an effective treatment option for patients with NSCLC. Longer follow-up is needed.

中文翻译：

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派姆单抗在非小细胞肺癌患者中的真实疗效和安全性：一项回顾性观察研究。

背景：

Pembrolizumab 是一种针对程序性细胞死亡 1 受体的人源化免疫球蛋白单克隆抗体，在临床试验中在多种肿瘤类型中表现出强大的疗效和可控的安全性。

目标：

研究一线派姆单抗在临床实践中对非小细胞肺癌（NSCLC）患者的疗效和安全性。

方法：

在这项观察性单中心回顾性研究中，38 名 PD-L1 > 50% 的患者在 2017 年 11 月至 2018 年 11 月期间入组。

结果：

全球中位总生存期为 11.08 个月（95% 置信区间 [CI]，5.98–未达到），全球中位无进展生存期为 6 个月（95% CI，3–未达到）。在单变量分析中，临床表现状态评分和免疫相关不良事件的发生是仅有的两个与总生存期显着相关的临床因素。

结论：

本研究结果表明，pembrolizumab 在现实人群中的效果似乎不如在 NSCLC 患者的关键临床试验中有效，但仍然是 NSCLC 患者的有效治疗选择。需要更长的随访时间。