Department of Respiratory Medicine, Comprehensive Cancer Center, Saitama Medical University International Medical Center, Hidaka, Saitama, Japan.
Division of Respiratory Medicine, Gunma Prefectural Cancer Center, 617-1, Takahayashinishi, Ota, Gunma, 373-8550, Japan.
Cancer Chemother Pharmacol. 2020 Apr;85(4):761-771. doi: 10.1007/s00280-020-04055-7. Epub 2020 Mar 19.
Immune checkpoint inhibitors (ICIs) are an effective subsequent-line treatment for patients with advanced non-small cell lung cancer (NSCLC). However, it remains unclear whether the efficacy and safety of subsequent-line ICI monotherapy in elderly patients (aged ≥ 75 years) are similar to that in non-elderly patients. Therefore, we aimed to investigate the efficacy and safety of ICI monotherapy in pretreated elderly patients with NSCLC.
Between January 2016 and February 2018, 131 elderly patients with advanced NSCLC who received subsequent-line ICI monotherapy at 13 Japanese institutions were enrolled in this study. Baseline characteristics, the efficacy of ICI treatment, and adverse events were evaluated.
Ninety-eight men and 33 women (median age 77 [range 75-87] years) were enrolled. Among those who received subsequent-line ICI monotherapy, the overall response, disease control rates, median progression-free survival (PFS), and overall survival (OS) were 27.4%, 61.8%, 4.5 months, and 16.0 months, respectively. Adverse events such as anorexia, fatigue, pneumonitis, and hypothyroidism were observed. There were two treatment-related deaths due to pneumonitis and thrombocytopenia. Subsequent-line ICI monotherapy in patients with good performance status (PS), receiving steroids for immune-related adverse events (irAEs), and exhibiting partial response (PR) was associated with improved PFS, as well as OS in patients with good PS and PR.
Subsequent-line ICI monotherapy in elderly patients, with previously treated NSCLC, was effective, safe and showed outcomes equivalent to those in non-elderly patients. Immunotherapy provides a survival benefit for elderly patients, who exhibit its efficacy and a favorable general condition.
免疫检查点抑制剂（ICI）是治疗晚期非小细胞肺癌（NSCLC）患者的有效二线治疗药物。然而，ICI 二线单药治疗在老年患者（≥75 岁）中的疗效和安全性是否与非老年患者相似尚不清楚。因此，我们旨在研究 ICI 二线单药治疗老年 NSCLC 患者的疗效和安全性。
本研究纳入了 2016 年 1 月至 2018 年 2 月在日本 13 家机构接受 ICI 二线单药治疗的 131 例老年晚期 NSCLC 患者。评估了患者的基线特征、ICI 治疗的疗效和不良反应。
共纳入 98 例男性和 33 例女性（中位年龄 77[75-87]岁）。二线 ICI 单药治疗的患者总缓解率、疾病控制率、中位无进展生存期（PFS）和总生存期（OS）分别为 27.4%、61.8%、4.5 个月和 16.0 个月。观察到厌食、乏力、肺炎和甲状腺功能减退等不良反应。有 2 例因肺炎和血小板减少导致治疗相关死亡。对于体能状态（PS）较好、因免疫相关不良反应（irAE）接受类固醇治疗、部分缓解（PR）的患者，二线 ICI 单药治疗与改善 PFS 以及 PS 较好和 PR 的患者的 OS 相关。
对于先前接受过治疗的 NSCLC 老年患者，ICI 二线单药治疗是有效且安全的，其疗效和患者的一般状况与非老年患者相当。免疫治疗为具有疗效和良好一般状况的老年患者带来了生存获益。
