Li Xiao-Ping, Zhang Wei-Dong, Li Ming-Jiang, Wang Juan, Lian Jie, Zhou Hong-Gang
Department of Thoracic Surgery, Tianjin First Central Hospital, School of Medicine, Nankai University, Tianjin, China.
State Key Laboratory of Medicinal Chemical Biology, College of Pharmacy and Tianjin Key Laboratory of Molecular Drug Research, Nankai University, Haihe Education Park, Tianjin, China.
J Oncol. 2022 Jul 22;2022:1710272. doi: 10.1155/2022/1710272. eCollection 2022.
Immunotherapy represented by PD-1 blockades had become the standard of care for advanced non-small cell lung cancer (NSCLC) gradually. Unfortunately, several PD-1 inhibitor-related studies excluded elderly patients with NSCLC over 75 years of age, resulting in relatively limited evidence regarding the efficacy and safety of PD-1 in elderly patients with NSCLC clinically.
This study aimed to identify the effectiveness and safety of PD-1 blockade monotherapy among elderly patients with advanced NSCLC.
Elderly patients with advanced NSCLC (≥65 years) who received PD-1 blockade monotherapy from September 2018 to December 2021 were screened retrospectively, and a total of 68 elderly patients with NSCLC were eligible for inclusion ultimately. The PD-1 blockades in the study were the available PD-1 monoclonal antibodies that had been approved for marketing in China, including camrelizumab, sintilimab, pembrolizumab, and nivolumab. The effectiveness and safety of the patients was collected retrospectively. Additionally, the correlation between prognosis and baseline characteristic subgroups was analyzed to identify the potential risk factors for progression-free survival (PFS).
The median age of the 68 elderly patients with advanced NSCLC was 73 years (range: 65-82 years). Best overall response during PD-1 blockade administration suggested that no patients were found with complete response, partial response was found in 14 patients, stable disease was noted in 29 patients, and 25 patients had progressive disease, yielding an objective response rate (ORR) of 20.6% (95%CI: 11.7%-32.1%) and a disease control rate (DCR) of 63.2% (95%CI: 50.7%-74.6%). Furthermore, prognostic analysis exhibited that the median progression-free survival (PFS) of the 68 patients with advanced NSCLC was 3.5 months (95%CI: 2.4-4.6) and the median overall survival (OS) was 10.5 months (95%CI: 6.3-14.7). Additionally, a total of 48 patients were observed with the treatment-related adverse reaction (70.6%) of the 68 elderly patients with NSCLC, and the incidence of grade 3 or above adverse reactions was 16.2%. Specifically, the most common adverse reactions were fatigue, diarrhea, rash, and abnormal liver function with the incidence of 25.0%, 22.1%, 16.2%, and 14.7%, respectively. Exploratory analysis between PFS and baseline characteristic subgroups suggested that ECOG performance status and number of metastatic lesions might be independent factors for PFS.
PD-1 blockade monotherapy exhibited potential effectiveness and acceptable toxicity for elderly patients with NSCLC. ECOG performance status and number of metastatic lesions might be potential risk factors to predict the PFS of elderly patients with advanced NSCLC.
以PD-1阻断为代表的免疫疗法已逐渐成为晚期非小细胞肺癌（NSCLC）的标准治疗方法。不幸的是，几项与PD-1抑制剂相关的研究排除了75岁以上的老年NSCLC患者，导致临床上关于PD-1在老年NSCLC患者中的疗效和安全性的证据相对有限。
本研究旨在确定PD-1阻断单药治疗在老年晚期NSCLC患者中的有效性和安全性。
回顾性筛选2018年9月至2021年12月接受PD-1阻断单药治疗的老年晚期NSCLC患者（≥65岁），最终共有68例老年NSCLC患者符合纳入标准。本研究中的PD-1阻断剂为已在中国获批上市的可用PD-1单克隆抗体，包括卡瑞利珠单抗、信迪利单抗、帕博利珠单抗和纳武利尤单抗。回顾性收集患者的有效性和安全性。此外，分析预后与基线特征亚组之间的相关性，以确定无进展生存期（PFS）的潜在危险因素。
68例老年晚期NSCLC患者的中位年龄为73岁（范围：65 - 82岁）。PD-1阻断治疗期间的最佳总体反应表明，未发现完全缓解的患者，14例患者部分缓解，29例患者疾病稳定，25例患者疾病进展，客观缓解率（ORR）为20.6%（95%CI：11.7% - 32.1%），疾病控制率（DCR）为63.2%（95%CI：50.7% - 74.6%）。此外，预后分析显示，68例晚期NSCLC患者的中位无进展生存期（PFS）为3.5个月（95%CI：2.4 - 4.6），中位总生存期（OS）为10.5个月（95%CI：6.3 - 14.7）。此外，68例老年NSCLC患者中共有48例观察到治疗相关不良反应（70.6%），3级及以上不良反应的发生率为16.2%。具体而言，最常见的不良反应为疲劳、腹泻、皮疹和肝功能异常，发生率分别为25.0%、22.1%、16.2%和14.7%。PFS与基线特征亚组之间的探索性分析表明，ECOG体能状态和转移灶数量可能是PFS的独立因素。
PD-1阻断单药治疗对老年NSCLC患者显示出潜在疗效和可接受的毒性。ECOG体能状态和转移灶数量可能是预测老年晚期NSCLC患者PFS的潜在危险因素。
