文章：

一线西米普利单抗单药治疗PD-L1表达≥50%的转移性非小细胞肺癌（NSCLC）的真实世界数据：一项西班牙全国多中心队列研究（CEMI-SPA研究）

Real-World Data of First-Line Cemiplimab Monotherapy for Metastatic Non-Small Cell Lung Cancer (NSCLC) with PD-L1 Expression ≥ 50%: A National Spanish Multicentric Cohort (CEMI-SPA Study)

原文发布日期：13 November 2025

DOI: 10.3390/cancers17223643

类型: Article

开放获取: 是

英文摘要：

Background/Objectives:Anti–PD-1/PD-L1 blockers have revolutionized the treatment landscape of non–small cell lung cancer (NSCLC) lacking oncogene-addicted alterations, particularly in tumors with high PD-L1 expression (tumor proportion score [TPS] ≥ 50%). Cemiplimab is approved as first-line monotherapy in this setting. However, real-world data remain scarce. This study aimed to evaluate the efficacy and safety of single-agent cemiplimab in a multicenter Spanish cohort and compare outcomes with a historical pembrolizumab cohort.Methods:Cemi-SPA is a retrospective multicenter study including 150 patients with advanced NSCLC and PD-L1 ≥ 50% treated with cemiplimab as first-line monotherapy across 21 Spanish centers. Clinical outcomes were analyzed and compared with a historical cohort of 144 patients treated with pembrolizumab. Propensity score matching (PSM) was performed to adjust for baseline differences.Results:Median progression-free survival (PFS) and overall survival (OS) were 8.1 and 12.6 months, respectively. ECOG performance status ≥ 2 was independently associated with worse outcomes, whereas the development of immune-related adverse events correlated with improved PFS and OS. After PSM, no significant differences were observed between cemiplimab and pembrolizumab in terms of efficacy.Conclusions:Cemiplimab demonstrated comparable real-world efficacy and safety to pembrolizumab in patients with advanced NSCLC and PD-L1 ≥ 50%. ECOG performance status emerged as the strongest prognostic factor, highlighting the importance of patient selection in routine clinical practice.

摘要翻译： 

背景/目的：抗PD-1/PD-L1抑制剂彻底改变了无致癌基因驱动突变的非小细胞肺癌（NSCLC）治疗格局，尤其在高PD-L1表达（肿瘤比例评分[TPS]≥50%）的肿瘤中。西米普利单抗在此背景下被批准作为一线单药疗法。然而，真实世界数据仍然匮乏。本研究旨在评估西班牙多中心队列中西米普利单抗单药治疗的疗效和安全性，并与历史帕博利珠单抗队列的结局进行比较。 方法：Cemi-SPA是一项回顾性多中心研究，纳入了来自西班牙21个中心的150例接受西米普利单抗作为一线单药治疗的晚期NSCLC且PD-L1≥50%的患者。分析其临床结局，并与144例接受帕博利珠单抗治疗的历史队列进行比较。采用倾向性评分匹配（PSM）调整基线差异。 结果：中位无进展生存期（PFS）和总生存期（OS）分别为8.1个月和12.6个月。ECOG体能状态≥2与较差的结局独立相关，而免疫相关不良事件的发生则与改善的PFS和OS相关。经过PSM后，西米普利单抗与帕博利珠单抗在疗效方面未观察到显著差异。 结论：在PD-L1≥50%的晚期NSCLC患者中，西米普利单抗显示出与帕博利珠单抗相当的真实世界疗效和安全性。ECOG体能状态成为最强的预后因素，凸显了在常规临床实践中患者选择的重要性。

原文链接：

Real-World Data of First-Line Cemiplimab Monotherapy for Metastatic Non-Small Cell Lung Cancer (NSCLC) with PD-L1 Expression ≥ 50%: A National Spanish Multicentric Cohort (CEMI-SPA Study)