Department of Thoracic Oncology, National Cancer Center Hospital, Tokyo, Japan.
Department of Respiratory Medicine, Juntendo University Graduate School of Medicine, Tokyo, Japan.
Cancer Med. 2023 Jun;12(11):12388-12401. doi: 10.1002/cam4.5939. Epub 2023 Apr 16.
It is still unclear whether patients with advanced non-small cell lung cancer (NSCLC), with disease progression after initial immune checkpoint inhibitor (ICI) therapy, would benefit from ICIs readministration.
We retrospectively collected data from patients with advanced NSCLC who received ICI retreatment. Depending on the disease status at the discontinuation of the initial ICI therapy, the patients were divided into two groups: with disease progression (PD group) and without disease progression (Without PD group). Patients in the Without PD group were required to experience disease progression during the treatment-free period. Efficacy was assessed by measuring the objective response rate (ORR) and progression-free survival in retreatment (PFS-R), while safety was assessed using the incidence of immune-related adverse events (irAEs).
30 (46.7%) of 64 eligible patients were included in the PD group and 34 (53.1%) in the Without PD group. Patients in the Without PD group had better clinical outcomes than those in the PD group (ORR, 29.4% vs. 6.7%; p = 0.03, median PFS-R, 4.1 months vs. 2.2 months, hazard ratio [HR], 0.61; 95% confidence interval [CI], 0.36-1.04; p = 0.07). Multivariate Cox regression analysis showed that patients in the Without PD group had significantly longer PFS-R than those in the PD group (HR 0.42, 95% CI, 0.21-0.85; p = 0.015). In terms of safety, 28.1% of patients observed irAEs during ICI retreatment, and the incidence rate of grade 3 or higher irAEs was 7.8%. Specifically, of the 28 patients who discontinued their initial ICI treatment because of irAEs, 35.7% developed irAEs, and 28.6% experienced relapsed irAEs during ICI retreatment.
Immune checkpoint inhibitor retreatment demonstrated efficacy in patients who discontinued initial ICI therapy for reasons other than disease progression. However, ICI retreatment was ineffective in patients with disease progression during the initial ICI treatment.
对于初始免疫检查点抑制剂（ICI）治疗后疾病进展的晚期非小细胞肺癌（NSCLC）患者，是否会从重新应用 ICI 中获益仍不清楚。
我们回顾性收集了接受 ICI 再治疗的晚期 NSCLC 患者的数据。根据初始 ICI 治疗停药时的疾病状态，将患者分为两组：疾病进展（PD 组）和无疾病进展（无 PD 组）。无 PD 组的患者要求在无治疗期内发生疾病进展。通过测量再治疗的客观缓解率（ORR）和无进展生存期（PFS-R）来评估疗效，同时使用免疫相关不良事件（irAEs）的发生率来评估安全性。
在 64 名符合条件的患者中，有 30 名（46.7%）患者被纳入 PD 组，34 名（53.1%）患者被纳入无 PD 组。无 PD 组患者的临床结局优于 PD 组（ORR，29.4%比 6.7%；p=0.03，中位 PFS-R，4.1 个月比 2.2 个月，风险比[HR]，0.61；95%置信区间[CI]，0.36-1.04；p=0.07）。多变量 Cox 回归分析显示，无 PD 组患者的 PFS-R 明显长于 PD 组（HR 0.42，95%CI，0.21-0.85；p=0.015）。在安全性方面，有 28.1%的患者在 ICI 再治疗期间观察到 irAEs，3 级或以上 irAEs 的发生率为 7.8%。具体来说，在因 irAEs 而停止初始 ICI 治疗的 28 名患者中，有 35.7%的患者发生了 irAEs，28.6%的患者在 ICI 再治疗期间发生了复发性 irAEs。
对于因非疾病进展原因而停止初始 ICI 治疗的患者，ICI 再治疗显示出疗效。然而，对于初始 ICI 治疗期间疾病进展的患者，ICI 再治疗无效。
