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.

Fusco, N., Ivanova, M., Frascarelli, C., Criscitiello, C., Cerbelli, B., Pignataro, M., et al. (2023). Advancing the PD-L1 CPS test in metastatic TNBC: Insights from pathologists and findings from a nationwide survey. CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY, 190(October 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

Ivanova, Mariia;Pagni, Fabio;Di Bella, Camillo;
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.
Articolo in rivista - Review Essay
22C3; Biomarkers; Breast cancer; CPS; Immunotherapy; PD-L1; SP263; TNBC;
English
16-ago-2023
2023
190
October 2023
104103
none
Fusco, N., Ivanova, M., Frascarelli, C., Criscitiello, C., Cerbelli, B., Pignataro, M., et al. (2023). Advancing the PD-L1 CPS test in metastatic TNBC: Insights from pathologists and findings from a nationwide survey. CRITICAL REVIEWS IN ONCOLOGY HEMATOLOGY, 190(October 2023) [10.1016/j.critrevonc.2023.104103].
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Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10281/435018
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