Department of Hematology, Oncology, and Respiratory Medicine, Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences, Okayama, Japan.
Department of Allergy and Respiratory Medicine, Okayama University Hospital, Okayama, Japan.
Cancer Sci. 2020 Oct;111(10):3739-3746. doi: 10.1111/cas.14590. Epub 2020 Aug 26.
Most clinical trials of non-small-cell lung cancer (NSCLC) exclude patients with poor ECOG performance status (PS). Thus, the efficacy of immune checkpoint inhibitors (ICIs) in patients with poor PS remains unclear. Herein, we used data from a retrospective cohort to assess the potential clinical benefits of ICIs in NSCLC patients with poor PS. Data from NSCLC patients who received ICI monotherapy at 9 institutions between December 2015 and May 2018 were retrospectively analyzed. After excluding 4 patients who lacked PS data, a total of 527 ICI-treated patients, including 79 patients with PS 2 or higher, were used for our analyses. The progression-free survival (PFS) and overall survival (OS) of patients with PS 2 or higher were significantly shorter compared with those of PS 0-1 patients (median PFS, 4.1 vs 2.0 months; P < .001 and median OS, 17.4 vs 4.0 months; P < .001). Among NSCLC patients with programmed cell death protein-ligand 1 (PD-L1) expression of 50% or higher who were treated with pembrolizumab as first-line therapy, the median PFS times of patients with PS 2 and 0-1 were 7.3 and 8.1 months, respectively. There was no significant difference in PFS between patients with PS 2 and 0-1 (P = .321). Although poor PS was significantly associated with worse outcomes in NSCLC patients treated with ICIs, pembrolizumab as a first-line treatment in NSCLC patients expressing high levels of PD-L1 could provide a clinical benefit, even in patients with PS 2.
大多数非小细胞肺癌（NSCLC）的临床试验都排除了 ECOG 表现状态（PS）较差的患者。因此，免疫检查点抑制剂（ICI）在 PS 较差的患者中的疗效尚不清楚。在此，我们使用回顾性队列的数据来评估 ICI 在 PS 较差的 NSCLC 患者中的潜在临床获益。回顾性分析了 2015 年 12 月至 2018 年 5 月期间在 9 家机构接受 ICI 单药治疗的 NSCLC 患者的数据。排除 4 例缺乏 PS 数据的患者后，共对 527 例接受 ICI 治疗的患者（包括 PS 2 或更高的 79 例患者）进行了分析。PS 2 或更高的患者的无进展生存期（PFS）和总生存期（OS）明显短于 PS 0-1 的患者（中位 PFS，4.1 与 2.0 个月；P <.001 和中位 OS，17.4 与 4.0 个月；P <.001）。在接受帕博利珠单抗作为一线治疗的 PD-L1 表达水平为 50%或更高的 NSCLC 患者中，PS 2 和 0-1 的患者的中位 PFS 时间分别为 7.3 和 8.1 个月。PS 2 与 0-1 患者的 PFS 无显著差异（P =.321）。尽管 PS 较差与接受 ICI 治疗的 NSCLC 患者的结局较差显著相关，但在表达高水平 PD-L1 的 NSCLC 患者中，帕博利珠单抗作为一线治疗药物，即使在 PS 2 的患者中，也能提供临床获益。
