推进在转移性三阴性乳腺癌中的PD-L1 CPS检测：从病理学家的见解到全国调查的发现。
Advancing the PD-L1 CPS test in metastatic TNBC: Insights from pathologists and findings from a nationwide survey.
发表日期：2023 Aug 16
作者：
Nicola Fusco, Mariia Ivanova, Chiara Frascarelli, Carmen Criscitiello, Bruna Cerbelli, Maria Gemma Pignataro, Angelina Pernazza, Elham Sajjadi, Konstantinos Venetis, Giulia Cursano, Fabio Pagni, Camillo Di Bella, Marina Accardo, Michelina Amato, Paolo Amico, Caterina Bartoli, Giuseppe Bogina, Laura Bortesi, Renzo Boldorini, Sara Bruno, Daniela Cabibi, Pietro Caruana, Emanuele Dainese, Elisa De Camilli, Vladimiro Dell'Anna, Loren Duda, Carmela Emmanuele, Giuseppe Nicolò Fanelli, Bethania Fernandes, Gerardo Ferrara, Letizia Gnetti, Alessandra Gurrera, Giorgia Leone, Raffaella Lucci, Cristina Mancini, Grazia Marangi, Mauro G Mastropasqua, Lorenzo Nibid, Sandra Orrù, Maria Pastena, Monica Peresi, Letizia Perracchio, Angela Santoro, Vania Vezzosi, Claudia Zambelli, Valeria Zuccalà, Antonio Rizzo, Leopoldo Costarelli, Francesca Pietribiasi, Alfredo Santinelli, Cristian Scatena, Giuseppe Curigliano, Elena Guerini-Rocco, Maurizio Martini, Paolo Graziano, Isabella Castellano, Giulia d'Amati
来源：
CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY
摘要：
Pembrolizumab被批准作为无法手术/转移的三阴性乳腺癌（mTNBC）一线治疗，其PD-L1联合阳性评分（CPS）≥ 10。然而，评估mTNBC中的CPS存在挑战。首先，它对乳腺病理学家来说代表着一项新的分析。其次，mTNBC中PD-L1表达的异质性进一步加剧了评估的复杂性。最后，缺乏标准化的检测方法和染色平台增加了复杂性。在KEYNOTE试验中，使用IHC 22C3 pharmDx试剂盒作为伴随诊断试验评估PD-L1表达。然而，22C3 pharmDx和VENTANA PD-L1（SP263）试验都被验证用于CPS评估。因此，试剂盒平台的选择、染色条件和评分方法可显著影响测试结果。本共识论文旨在讨论mTNBC中PD-L1 CPS测试的复杂性，并为病理学家提供实用建议。此外，我们还介绍了一项全国范围的意大利调查，阐明了mTNBC中PD-L1 CPS测试的现状。版权所有 © 2023 Elsevier B.V. 保留所有权利。
Pembrolizumab has received approval as a first-line treatment for unresectable/metastatic triple-negative breast cancer (mTNBC) with a PD-L1 combined positive score (CPS) of ≥ 10. However, assessing CPS in mTNBC poses challenges. Firstly, it represents a novel analysis for breast pathologists. Secondly, the heterogeneity of PD-L1 expression in mTNBC further complicates the assessment. Lastly, the lack of standardized assays and staining platforms adds to the complexity. In KEYNOTE trials, PD-L1 expression was evaluated using the IHC 22C3 pharmDx kit as a companion diagnostic test. However, both the 22C3 pharmDx and VENTANA PD-L1 (SP263) assays are validated for CPS assessment. Consequently, assay-platform choice, staining conditions, and scoring methods can significantly impact the testing outcomes. This consensus paper aims to discuss the intricacies of PD-L1 CPS testing in mTNBC and provide practical recommendations for pathologists. Additionally, we present findings from a nationwide Italian survey elucidating the state-of-the-art in PD-L1 CPS testing in mTNBC.Copyright © 2023 Elsevier B.V. All rights reserved.