Immunotherapy represented by programmed death protein-1 (PD-1) inhibitors has gradually become the standard treatment of advanced non-small cell lung cancer (NSCLC) in recent years, changing the treatment landscape of advanced NSCLC. However, most PD-1-related studies excluded patients with NSCLC more than 70 or 75 years, resulting in relatively limited data about the efficacy and safety of PD-1 inhibitors in elderly patients.

This study aims to evaluate the efficacy and safety of PD-1 inhibitors in elderly patients with advanced NSCCL.

This study selected elderly patients with advanced NSCLC over 65 years who received PD-1 inhibitors monotherapy in Department of Thoracic Surgery and Oncology of the Fourth Affiliated Hospital of Gansu University of Traditional Chinese Medicine from October 2018 to November 2021. A total of 63 elderly patients with NSCLC were included. The PD-1 inhibitors of the study were approved in Chinese market, including camrelizumab, sintilimab and pembrolizumab. The data about efficacy and safety of PD-1 inhibitors were collected in the hospital electronic medical record system. All patients were followed up regularly to obtain the long-term prognostic data until 2022-03-15. The efficacy data of PD-1 inhibitors, the prognosis of elderly patients with advanced NSCLC and the toxicity and side effects of PD-1 inhibitors were collected. Cox comparative risk model was used to explore the influencing factors of the prognosis of elderly patients with advanced NSCLC.

The median age of the 63 elderly patients with advanced NSCLC was 71 (65, 89) years. The best response assessment during PD-1 inhibitors therapy showed that no patients had complete response, 14 patients had partial responses, 21 patients had stable status, and 28 patients had progressive status. The objective response rate (ORR) of patients with advanced NSCLC treated with PD-1 inhibitors monotherapy was 22.2% (14/63) , and the disease control rate (DCR) was 66.7% (14/21) . Prognostic data showed that the median progression free survival (PFS) of the 63 patients with advanced NSCLC was 3.3 (2.0, 4.6) months and the median overall survival (OS) was 10.2 (6.1, 14.3) months. Among 63 elderly patients with NSCLC, 46 of them (73.0%) had treatment related adverse reaction during PD-1 inhibitors monotherapy, and the rate of grade 3 or above adverse reactions was 14.3%. The most common adverse reactions were fatigue, diarrhea, rash and abnormal liver function with the rates of 23.8% (15/63) , 19.1% (12/63) , 15.9% (10/63) and 14.3% (9/63) , respectively. Cox comparative risk model analysis suggested that ECOG performance status and number of metastatic lesions might be independent factors of PFS in patients with advanced NSCLC treated with PD-1 inhibittors.

PD-1 blockades monotherapy demonstrated potential efficacy and acceptable safety for elderly patients with NSCLC. ECOG performance status and number of metastatic lesions might be potential risk factors that predict the PFS of the patients.

以程序性死亡蛋白-1（PD-1）抑制剂为代表的免疫治疗近年来逐步成为晚期非小细胞肺癌（NSCLC）的标准治疗方案，改变了该病的治疗格局。大部分PD-1抑制剂相关研究排除了70或75岁以上的老年晚期NSCLC患者，使得老年患者使用PD-1抑制剂治疗的疗效及安全性数据相对较少。

本研究旨在探讨PD-1抑制剂在老年晚期NSCLC患者中的疗效及安全性。

选取2018年10月至2021年11月在甘肃中医药大学第四附属医院胸外科和肿瘤科接受PD-1抑制剂单药治疗的65岁及以上的晚期NSCLC患者，最终纳入符合标准的患者63例。本研究中PD-1抑制剂均为已经在中国获批上市的PD-1抑制剂单抗，包括卡瑞利珠单抗、信迪利单抗和帕博利珠单抗。通过医院电子病历系统整理患者接受治疗后的疗效及安全性数据，并对患者进行定期随访获取长期生存数据，随访至2022-03-15，收集患者PD-1抑制剂的疗效资料、老年晚期NSCLC患者的预后情况和接受PD-1抑制剂治疗的毒副作用情况，采用Cox比例风险模型探讨老年晚期NSCLC患者预后的影响因素。

63例老年晚期NSCLC患者的中位年龄为71（65，89）岁。接受PD-1抑制剂治疗期间的最佳疗效评估结果显示无患者完全缓解，14例患者获得部分缓解，21例患者疾病稳定，28例患者疾病进展。PD-1抑制剂单药治疗晚期NSCLC患者的客观缓解率（ORR）为22.2%（14/63），疾病控制率（DCR）为66.7%（14/21）。预后数据提示63例老年晚期NSCLC患者的中位无进展生存期（PFS）为3.3（2.0，4.6）个月。中位OS为10.2（6.1，14.3）个月。接受PD-1单药治疗期间，63例老年晚期NSCLC中46例患者出现了治疗相关的毒副作用（73.0%），其中3级以上的毒副作用发生率为14.3%（9/63）。常见的毒副作用类型有乏力、腹泻、皮疹和肝功能异常，发生率分别为23.8%（15/63）、19.1%（12/63）、15.9%（10/63）和14.3%（9/63）。Cox比例风险回归分析结果显示，东部肿瘤协作组（ECOG）体质状态评分和转移病灶数目是老年晚期NSCLC患者接受PD-1抑制剂后PFS的独立影响因素（HR=0.56、0.48）。

PD-1抑制剂单药在老年晚期NSCLC患者中具有初步的疗效和可耐受的安全性。ECOG体质状态评分和转移病灶数目可能是影响该类患者PFS的潜在风险因素。