由于缺乏关于老年晚期非小细胞肺癌（aNSCLC）免疫治疗的具体数据，我们设计了这项研究来确定70岁以上aNSCLC表达PD-L1的患者首线帕姆单抗一年内的总生存率（OS）。次要目标包括无进展生存期、疾病特异性生存期、响应率、耐受性、生活质量（QoL）变化和老年评估。在西班牙肺癌组织之间于2018年2月至2019年11月在西班牙的10个活跃现场进行了单臂、非盲、二期临床试验。我们纳入了年龄在70岁及以上，组织学或细胞学证实的IIIB期或IV期aNSCLC且PD-L1表达≥1%的患者。每个受试者每三周静脉注射200毫克的帕姆单抗，最长治疗两年。共招募了83名患者参与研究，最终分析了74名患者。其中大多数为男性（N = 64，86.5%）和以前吸烟者（N = 51，68.9%）。24名患者（32.4%）完成了至少一年的治疗，62名（83.7%）中断了治疗，30名（40.5%）出现疾病进展。我们队列的中位随访时间为18.0个月[范围：0.1-47.7]，46名患者（62.2%）在研究期间死亡。一年估计的总生存率为61.7%（95% CI：49.6-71.8%），我们队列的中位OS为19.2个月（95% CI：11.3-25.5）。在研究期间，QoL呈现改善的趋势，尽管差异无统计学意义。主要老年评分保持稳定，除了营养状况恶化（P = 0.004）和脆弱性改善（P = 0.028）。我们的结果支持使用帕姆单抗单药治疗表达PD-L1的老年aNSCLC患者。大多数老年评分稳定且患者QoL呈现积极趋势，尽管我们的结果未达到统计学意义。版权所有©2023作者。由Elsevier B.V.出版。保留所有权利。

Since specific data on immunotherapy in older adults with advanced non-small cell lung cancer (aNSCLC) are scarce, we designed this study to determine the overall survival (OS) at one year of first-line pembrolizumab in patients older than 70 years with aNSCLC expressing PD-L1. Secondary objectives included progression-free survival, disease-specific survival, response rate, tolerability, quality of life (QoL) changes, and geriatric assessments.A single-arm, open-label, phase II clinical trial was carried out by the Spanish Lung Cancer Group between February 2018 and November 2019 at ten active sites in Spain. We included patients 70 years old and older with histological or cytological documented stage IIIB or IV aNSCLC and PD-L1 expression ≥ 1%. Each subject received 200 mg of intravenous pembrolizumab every three weeks for a maximum of two years.83 patients were recruited for the study and 74 were finally analysed. Most were male (N = 64, 86.5%) and former smokers (N = 51, 68.9%). 24 patients (32.4%) completed at least one year of treatment, 62 (83.7%) discontinued treatment, and 30 (40.5%) experienced disease progression. The median follow-up of our cohort was 18.0 months [range: 0.1-47.7] and 46 patients (62.2%) died during the period of study. The estimated OS at one year was 61.7% (95% CI: 49.6-71.8%) and the median OS of our cohort was 19.2 months (95% CI: 11.3-25.5). QoL tended to improve throughout the study, although the differences were not statistically significant. The main geriatric scores remained stable, except for a worsening in nutritional status (P = 0.004) and an improvement in frailty (P = 0.028).Our results support treating older adults with aNSCLC expressing PD-L1 with pembrolizumab in monotherapy. The stability of most geriatric scores and the positive trend on the patients' QoL should be highlighted, although our results did not reach statistical significance.Copyright © 2023 The Author(s). Published by Elsevier B.V. All rights reserved.