Division of Pulmonology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
Division of Oncology, Department of Internal Medicine, Medical University of Graz, Graz, Austria.
J Immunother Cancer. 2024 Apr 11;12(4):e008592. doi: 10.1136/jitc-2023-008592.
The use and approval of immune checkpoint inhibitors for the treatment of non-small cell lung cancer (NSCLC) depends on PD-L1 expression in the tumor tissue. Nevertheless, PD-L1 often fails to predict response to treatment. One possible explanation could be a change in PD-L1 expression during the course of the disease and the neglect of reassessment. The purpose of this study was a longitudinal analysis of PD-L1 expression in patients with relapsed NSCLC.
We retrospectively analyzed PD-L1 expression in patients with early-stage NSCLC and subsequent relapse in preoperative samples, matched surgical specimens and biopsy samples of disease recurrence. Ventana PD-L1 (SP263) immunohistochemistry assay was used for all samples. PD-L1 expression was scored based on clinically relevant groups (0%, 1%-49%, and ≥50%). The primary endpoint was the change in PD-L1 score group between preoperative samples, matched surgical specimens and relapsed tumor tissue.
395 consecutive patients with stages I-III NSCLC and 136 (34%) patients with a subsequent relapse were identified. For 87 patients at least two specimens for comparison of PD-L1 expression between early stage and relapsed disease were available. In 72 cases, a longitudinal analysis between preoperative biopsy, the surgically resected specimen and biopsy of disease recurrence was feasible. When comparing preoperative and matched surgical specimens, a treatment-relevant conversion of PD-L1 expression group was found in 25 patients (34.7%). Neoadjuvant treatment showed no significant effect on PD-L1 alteration (p=0.39). In 32 (36.8%) out of 87 cases, a change in PD-L1 group was observed when biopsies of disease relapse were compared with early-stage disease. Adjuvant treatment was not significantly associated with a change in PD-L1 expression (p=0.53). 39 patients (54.2%) showed at least 1 change into a different PD-L1 score group during the course of disease. 14 patients (19.4%) changed the PD-L1 score group twice, 5 (6.9%) of them being found in all different score groups.
PD-L1 expression shows dynamic changes during the course of disease. There is an urgent need for consensus guidelines to define a PD-L1 testing strategy including time points of reassessment, the number of biopsies to be obtained and judgment of surgical specimens.
免疫检查点抑制剂治疗非小细胞肺癌（NSCLC）的使用和批准取决于肿瘤组织中的 PD-L1 表达。然而，PD-L1 常常无法预测治疗反应。一种可能的解释是疾病过程中 PD-L1 表达的变化以及忽视重新评估。本研究的目的是对复发性 NSCLC 患者的 PD-L1 表达进行纵向分析。
我们回顾性分析了早期 NSCLC 患者术前样本、匹配的手术标本和疾病复发时活检样本中的 PD-L1 表达。所有样本均采用 Ventana PD-L1（SP263）免疫组织化学检测。根据临床相关组（0%、1%-49%和≥50%）对 PD-L1 表达进行评分。主要终点是术前样本、匹配的手术标本和复发性肿瘤组织之间 PD-L1 评分组的变化。
确定了 395 例 I-III 期 NSCLC 患者和 136 例（34%）随后复发的患者。对于至少有两个标本可比较早期疾病和复发疾病 PD-L1 表达的 87 例患者。在 72 例患者中，对术前活检、手术切除标本和疾病复发时活检之间的纵向分析是可行的。当比较术前和匹配的手术标本时，发现 25 例（34.7%）患者 PD-L1 表达组发生了治疗相关的转换。新辅助治疗对 PD-L1 改变没有显著影响（p=0.39）。在 87 例患者中的 32 例（36.8%）中，与早期疾病相比，疾病复发时活检发现 PD-L1 组发生变化。辅助治疗与 PD-L1 表达的变化无显著相关性（p=0.53）。39 例（54.2%）患者在疾病过程中至少有 1 次进入不同的 PD-L1 评分组。14 例（19.4%）患者 PD-L1 评分组发生两次变化，其中 5 例（6.9%）患者在所有不同评分组中均有发现。
PD-L1 表达在疾病过程中发生动态变化。迫切需要制定共识指南，定义 PD-L1 检测策略，包括重新评估的时间点、要获得的活检数量以及对手术标本的判断。
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