Department of Pathology, Yonsei University College of Medicine, Seoul, Korea.
Department of Surgery, Yonsei University College of Medicine, Seoul, Korea.
Yonsei Med J. 2023 Aug;64(8):518-525. doi: 10.3349/ymj.2023.0090.
Pembrolizumab is currently used to treat advanced triple-negative breast cancer (TNBC) and high-risk early TNBC with neoadjuvant chemotherapy (NAC). The tumor-infiltrating lymphocyte (TIL) level and programmed cell death ligand 1 (PD-L1) status are predictors of response to NAC and immune checkpoint inhibitor treatment. We aimed to investigate whether the PD-L1 status in core needle biopsies (CNBs) could represent the whole tumor in TNBC.
A total of 49 patients diagnosed with TNBC who received upfront surgery without NAC between January 2018 and March 2021 were included. The PD-L1 expression (SP142 and 22C3 clones) and TIL were evaluated in paired CNBs and resected specimens. The concordance PD-L1 status and TIL levels between CNBs and resected specimens were analyzed.
PD-L1 positivity was more frequently observed in resected specimens. The overall reliability of TIL level in the CNB was good [intraclass correlation coefficient (ICC)=0.847, <0.001]. The agreements of PD-L1 status were good and fair, respectively (SP142, κ=0.503, <0.001; 22C3, κ=0.380, =0.010). As the core number of CNB increased, the reliability and agreement also improved, especially from five tumor cores (TIL, ICC=0.911, <0.001; PD-L1 [22C3], κ=0.750, =0.028). Regarding PD-L1 (SP142), no further improvement was observed with ≥5 tumor cores (κ=0.600, =0.058).
CNBs with ≥5 tumor cores were sufficient to represent the TIL level and PD-L1 (22C3) status in TNBC.
帕博利珠单抗目前被用于治疗晚期三阴性乳腺癌（TNBC）和接受新辅助化疗（NAC）的高危早期 TNBC。肿瘤浸润淋巴细胞（TIL）水平和程序性死亡配体 1（PD-L1）状态是 NAC 和免疫检查点抑制剂治疗反应的预测因子。我们旨在研究 TNBC 中核心针活检（CNB）中的 PD-L1 状态是否可以代表整个肿瘤。
共纳入 2018 年 1 月至 2021 年 3 月期间未经 NAC 直接接受手术治疗的 49 例 TNBC 患者。在配对的 CNB 和切除标本中评估 PD-L1 表达（SP142 和 22C3 克隆）和 TIL。分析 CNB 和切除标本之间 PD-L1 状态和 TIL 水平的一致性。
在切除标本中更频繁地观察到 PD-L1 阳性。CNB 中 TIL 水平的整体可靠性较好[组内相关系数（ICC）=0.847，<0.001]。PD-L1 状态的一致性较好和尚可，分别为（SP142，κ=0.503，<0.001；22C3，κ=0.380，=0.010）。随着 CNB 核心数量的增加，可靠性和一致性也得到提高，特别是从 5 个肿瘤核心开始（TIL，ICC=0.911，<0.001；PD-L1[22C3]，κ=0.750，=0.028）。对于 PD-L1（SP142），≥5 个肿瘤核心时没有进一步提高（κ=0.600，=0.058）。
≥5 个肿瘤核心的 CNB 足以代表 TNBC 中的 TIL 水平和 PD-L1（22C3）状态。
