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.G., 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 [10.1016/j.critrevonc.2023.104103].

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

Amico, Paolo;Bruno, Sara;Cabibi, Daniela;Caruana, Pietro;Rizzo, Antonio;Graziano, Paolo;
2023-10-01

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.
ott-2023
Fusco, N., Ivanova, M., Frascarelli, C., Criscitiello, C., Cerbelli, B., Pignataro, M.G., 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 [10.1016/j.critrevonc.2023.104103].
File in questo prodotto:
File Dimensione Formato  
1-s2.0-S1040842823001919-main.pdf

Solo gestori archvio

Tipologia: Versione Editoriale
Dimensione 1.87 MB
Formato Adobe PDF
1.87 MB Adobe PDF   Visualizza/Apri   Richiedi una copia

I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.

Utilizza questo identificativo per citare o creare un link a questo documento: https://hdl.handle.net/10447/619688
Citazioni
  • ???jsp.display-item.citation.pmc??? 0
  • Scopus 3
  • ???jsp.display-item.citation.isi??? 1
social impact