Concordance of PD-L1 Expression in Metastatic Triple-negative Breast Cancer Between the 22C3 and E1L3N Antibodies Using Combined Positive Scoring.

IF 1.3 4区 医学 Q3 ANATOMY & MORPHOLOGY Applied Immunohistochemistry & Molecular Morphology Pub Date : 2024-10-01 Epub Date: 2024-09-20 DOI:10.1097/PAI.0000000000001223
Timothy K Erick, Susan C Lester, Ana C Garrido-Castro, Melissa Hughes, Olivia Cunningham, Nancy U Lin, Elizabeth A Mittendorf, Sara M Tolaney, Jane E Brock
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Abstract

For patients with metastatic triple-negative breast cancer (TNBC), treatment with pembrolizumab is dependent on the accurate determination of programmed death ligand 1 (PD-L1) expression using immunohistochemistry (IHC). This study evaluated the interobserver concordance in assessing PD-L1 expression on TNBC samples using the commercial 22C3 IHC assay and an in-house assay based on the E1L3N antibody. Concordance between the 22C3 and the E1L3N IHC assays was evaluated on TNBC samples read by a commercial laboratory and a Brigham and Women's Hospital breast pathologist (BWH reader). Each slide was given a PD-L1 combined positive score (CPS) and was considered PD-L1 positive or negative based on the CPS cutoff of 10. Interobserver concordance for the assays was also evaluated on a subset of samples between 2 and 3 independent readers. On 71 samples, 2 independent readers (1 BWH reader and commercial laboratory) using E1L3N and 22C3, respectively, reached agreement on PD-L1 status (positive/negative) on 64 samples (90.1%). Using 22C3, 2 independent readers reached agreement on PD-L1 status on 30 of 36 samples (83.3%), and 3 independent readers reached agreement on 16 of 27 samples (59.3%). Using E1L3N, 2 BWH readers reached agreement on PD-L1 status on 18 of 27 samples (66.7%). Three BWH readers reached an agreement on 2 of 12 of the most challenging samples (16.7%). In conclusion, concordance between E1L3N and 22C3 testing using CPS for PD-L1 in metastatic TNBC was >90%. However, certain cases were challenging to agree upon using current threshold criteria, highlighting the need for more standardized evidence-based methods to assess PD-L1 expression.

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22C3 和 E1L3N 抗体采用联合阳性评分法检测转移性三阴性乳腺癌中 PD-L1 表达的一致性
对于转移性三阴性乳腺癌(TNBC)患者,使用 pembrolizumab 治疗取决于使用免疫组织化学(IHC)准确测定程序性死亡配体 1(PD-L1)的表达。本研究评估了使用商业 22C3 IHC 检测法和基于 E1L3N 抗体的内部检测法评估 TNBC 样本中 PD-L1 表达的观察者间一致性。由一家商业实验室和布莱根妇女医院乳腺病理学家(BWH 阅读器)对 TNBC 样本进行阅读,评估 22C3 和 E1L3N IHC 检测的一致性。每张切片都有一个 PD-L1 综合阳性评分 (CPS),根据 CPS 临界值 10 将其视为 PD-L1 阳性或阴性。此外,还对 2 至 3 位独立读片员对部分样本的检测结果进行了观察者间一致性评估。在 71 份样本中,2 位独立阅读者(1 位 BWH 阅读者和 1 位商业实验室阅读者)分别使用 E1L3N 和 22C3 对 64 份样本(90.1%)的 PD-L1 状态(阳性/阴性)达成一致。使用 22C3,2 位独立读数员对 36 个样本中的 30 个样本(83.3%)的 PD-L1 状态达成一致,3 位独立读数员对 27 个样本中的 16 个样本(59.3%)的 PD-L1 状态达成一致。使用 E1L3N,2 位 BWH 读数员对 27 个样本中的 18 个样本(66.7%)的 PD-L1 状态达成了一致。在 12 个最具挑战性的样本中,有 2 个样本(16.7%)与 3 位 BWH 阅读器达成了一致。总之,在转移性 TNBC 中使用 CPS 检测 PD-L1 时,E1L3N 和 22C3 检测的一致性大于 90%。然而,某些病例使用目前的阈值标准很难达成一致,这突出表明需要更标准化的循证方法来评估PD-L1的表达。
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来源期刊
Applied Immunohistochemistry & Molecular Morphology
Applied Immunohistochemistry & Molecular Morphology ANATOMY & MORPHOLOGY-MEDICAL LABORATORY TECHNOLOGY
CiteScore
3.20
自引率
0.00%
发文量
153
期刊介绍: ​Applied Immunohistochemistry & Molecular Morphology covers newly developed identification and detection technologies, and their applications in research and diagnosis for the applied immunohistochemist & molecular Morphologist. Official Journal of the International Society for Immunohistochemisty and Molecular Morphology​.
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