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 / N. Fusco, M. Ivanova, C. Frascarelli, C. Criscitiello, B. Cerbelli, M. Gemma Pignataro, A. Pernazza, E. Sajjadi, K. Venetis, G. Cursano, F. Pagni, C. Di Bella, M. Accardo, M. Amato, P. Amico, C. Bartoli, G. Bogina, L. Bortesi, R. Boldorini, S. Bruno, D. Cabibi, P. Caruana, E. Dainese, E. De Camilli, V. Dell’Anna, L. Duda, C. Emmanuele, G. Nicolò Fanelli, B. Fernandes, G. Ferrara, L. Gnetti, A. Gurrera, G. Leone, R. Lucci, C. Mancini, G. Marangi, M.G. Mastropasqua, L. Nibid, S. Orrù, M. Pastena, M. Peresi, L. Perracchio, A. Santoro, V. Vezzosi, C. Zambelli, V. Zuccalà, A. Rizzo, L. Costarelli, F. Pietribiasi, A. Santinelli, C. Scatena, G. Curigliano, E. Guerini-Rocco, M. Martini, P. Graziano, I. Castellano, G. D'Amati. - In: CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY. - ISSN 1040-8428. - 190:(2023), pp. 104103.1-104103.10. [10.1016/j.critrevonc.2023.104103]

Advancing the PD-L1 CPS test in metastatic TNBC: Insights from pathologists and findings from a nationwide survey

N. Fusco
Primo
;
C. Frascarelli;C. Criscitiello;E. Sajjadi;K. Venetis;G. Curigliano;E. Guerini-Rocco;
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.
22C3; Biomarkers; Breast cancer; CPS; Immunotherapy; PD-L1; SP263; TNBC
Settore MED/08 - Anatomia Patologica
Settore MED/06 - Oncologia Medica
2023
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/2434/1018834
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