Department of Pulmonary Medicine, Graduate School of Medical Science, Kyoto Prefectural University of Medicine, 465, Kajiicho, Kawaramachidori-hiro, Kyoto, Kyoto, 602-0841, Japan.
Department of Thoracic Oncology, Osaka International Cancer Institute, Osaka, Osaka, Japan.
Target Oncol. 2023 Nov;18(6):915-925. doi: 10.1007/s11523-023-01012-1. Epub 2023 Oct 30.
Immune checkpoint inhibitor (ICI) monotherapy and ICI plus chemotherapy are approved first-line treatments for patients with non-small cell lung cancer (NSCLC) expressing high levels of programmed cell death-ligand 1 (PD-L1). However, appropriate treatment for patients showing high PD-L1 expression and poor performance status (PS) is not well defined.
The aim of this study was to identify a treatment option that is better for these patients in a real-world setting.
A total of 425 patients with NSCLC and high PD-L1 expression were included retrospectively. All patients received either pembrolizumab monotherapy or ICI plus chemotherapy as the first-line treatment. Patients were subdivided into good (PS score 0 or 1; n = 354) and poor PS groups (PS score 2 or 3; n = 71). Early progressive disease (PD) was defined as PD within 3 months of ICI-based therapy initiation.
The good PS group had significantly longer progression-free survival (PFS) and overall survival (OS) than the poor PS group upon ICI-based therapy administration. In the poor PS group, no significant difference was observed in PFS and OS between pembrolizumab monotherapy and ICI plus chemotherapy. In the good PS group, pembrolizumab monotherapy, PD-L1 50-89%, and liver metastasis were associated with early PD, as determined using multivariate logistic regression analyses. However, in the poor PS group, the multivariate logistic regression analyses did not show an association between pembrolizumab monotherapy and early PD.
In patients with NSCLC exhibiting poor PS and high PD-L1 expression, ICI plus chemotherapy did not confer PFS or OS benefit compared with pembrolizumab monotherapy.
免疫检查点抑制剂（ICI）单药治疗和 ICI 联合化疗是 PD-L1 高表达的非小细胞肺癌（NSCLC）患者的一线治疗方案。然而，对于 PD-L1 高表达且表现状态（PS）不佳的患者，尚未明确最佳治疗方案。
本研究旨在确定在真实环境下，针对此类患者的更佳治疗选择。
共回顾性纳入 425 例 PD-L1 高表达的 NSCLC 患者。所有患者均接受了帕博利珠单抗单药治疗或 ICI 联合化疗作为一线治疗。患者被分为 PS 良好（PS 评分为 0 或 1；n=354）和 PS 不佳（PS 评分为 2 或 3；n=71）两组。早期疾病进展（PD）定义为 ICI 治疗开始后 3 个月内出现 PD。
在接受 ICI 治疗后，PS 良好组的无进展生存期（PFS）和总生存期（OS）显著长于 PS 不佳组。在 PS 不佳组中，与帕博利珠单抗单药治疗相比，ICI 联合化疗在 PFS 和 OS 方面无显著差异。在 PS 良好组中，多变量逻辑回归分析显示，帕博利珠单抗单药治疗、PD-L1 表达水平 50%-89%和肝转移与早期 PD 相关。然而，在 PS 不佳组中，多变量逻辑回归分析并未显示帕博利珠单抗单药治疗与早期 PD 之间存在关联。
对于 PS 不佳且 PD-L1 高表达的 NSCLC 患者，与帕博利珠单抗单药治疗相比，ICI 联合化疗并未带来 PFS 或 OS 获益。
