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.
Advancing the PD-L1 CPS test in metastatic TNBC: insights from pathologists and findings from a nationwide survey / Fusco, Nicola; Ivanova, Mariia; Frascarelli, Chiara; Criscitiello, Carmen; Cerbelli, Bruna; Pignataro, Maria Gemma; Pernazza, Angelina; Sajjadi, Elham; Venetis, Konstantinos; Cursano, Giulia; Pagni, Fabio; Di Bella, Camillo; Accardo, Marina; Amato, Michelina; Amico, Paolo; Bartoli, Caterina; Bogina, Giuseppe; Bortesi, Laura; Boldorini, Renzo; Bruno, Sara; Cabibi, Daniela; Caruana, Pietro; Dainese, Emanuele; De Camilli, Elisa; Dell'Anna, Vladimiro; Duda, Loren; Emmanuele, Carmela; Fanelli, Giuseppe Nicolò; Fernandes, Bethania; Ferrara, Gerardo; Gnetti, Letizia; Gurrera, Alessandra; Leone, Giorgia; Lucci, Raffaella; Mancini, Cristina; Marangi, Grazia; Mastropasqua, Mauro G; Nibid, Lorenzo; Orrù, Sandra; Pastena, Maria; Peresi, Monica; Perracchio, Letizia; Santoro, Angela; Vezzosi, Vania; Zambelli, Claudia; Zuccalà, Valeria; Rizzo, Antonio; Costarelli, Leopoldo; Pietribiasi, Francesca; Santinelli, Alfredo; Scatena, Cristian; Curigliano, Giuseppe; Guerini-Rocco, Elena; Martini, Maurizio; Graziano, Paolo; Castellano, Isabella; D'Amati, Giulia. - In: CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY. - ISSN 1040-8428. - 190:(2023). [10.1016/j.critrevonc.2023.104103]
Advancing the PD-L1 CPS test in metastatic TNBC: insights from pathologists and findings from a nationwide survey
Cerbelli, Bruna;Pignataro, Maria Gemma;Pernazza, Angelina;Graziano, Paolo;d'Amati, GiuliaUltimo
2023
Abstract
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.| File | Dimensione | Formato | |
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