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A multicentre analytical comparison study of inter-reader and inter-assay agreement of four programmed death-ligand 1 immunohistochemistry assays for scoring in triple-negative breast cancer

Aims Studies in various cancer types have demonstrated discordance between results from different programmed death-ligand 1 (PD-L1) assays. Here, we compare the reproducibility and analytical concordance of four clinically developed assays for assessing PD-L1-positivity in tumour-infiltrating immune...

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Main Authors: Noske, Aurelia (Author) , Ammann, Johannes Ulrich (Author) , Wagner, Daniel-Christoph (Author) , Denkert, Carsten (Author) , Lebeau, Annette (Author) , Sinn, Peter (Author) , Kreipe, Hans H. (Author) , Sommer, Ulrich (Author) , Baretton, Gustavo Bruno (Author) , Steiger, Katja (Author) , Kiechle, Marion (Author) , Hieke-Schulz, Stefanie (Author) , Flores, Mike (Author) , Roth, Wilfried (Author) , Weichert, Wilko (Author)
Format: Article (Journal)
Language:English
Published: March 2021
In: Histopathology
Year: 2021, Volume: 78, Issue: 4, Pages: 567-577
ISSN:1365-2559
DOI:10.1111/his.14254
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1111/his.14254
Verlag, kostenfrei, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/his.14254
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Author Notes:Aurelia Noske, Johannes U Ammann, Daniel-Christoph Wagner, Carsten Denkert, Annette Lebeau, Peter Sinn, Hans-Heinrich Kreipe, Ulrich Sommer, Gustavo Baretton, Katja Steiger, Marion Kiechle, Stefanie Hieke-Schulz, Mike Flores, Wilfried Roth & Wilko Weichert
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Summary:Aims Studies in various cancer types have demonstrated discordance between results from different programmed death-ligand 1 (PD-L1) assays. Here, we compare the reproducibility and analytical concordance of four clinically developed assays for assessing PD-L1-positivity in tumour-infiltrating immune cells in the tumour area (PD-L1-IC-positivity) in triple-negative breast cancer (TNBC). Methods and results Primary TNBC resection specimens (n = 30) were selected based on their PD-L1-IC-positivity per VENTANA SP142 (<1%: 15 cases; 1-5%: seven cases; >5%: eight cases). Serial histological sections were stained for PD-L1 using VENTANA SP142, VENTANA SP263, DAKO 22C3 and DAKO 28-8. PD-L1-IC-positivity and tumour cell expression (≥1 versus <1%) were scored by trained readers from seven sites using online virtual microscopy. The adjusted mean of PD-L1-IC-positivity for SP263 (7.8%) was significantly higher than those for the other three assays (3.7-4.9%). Differences in adjusted means were statistically significant between SP263 and the other three assays (P < 0.0001) but not between the three remaining assays when excluding SP263 (P = 0.0961-0.6522). Intra-class correlation coefficients revealed moderate-to-strong inter-reader agreement for each assay (0.460-0.805) and poor-to-strong inter-assay agreement for each reader (0.298-0.678) on PD-L1-IC-positivity. Conclusions In this first multicentre study of different PD-L1 assays in TNBC, we show that PD-L1-IC-positivity for SP142, 22C3 and 28-8 was reproducible and analytically concordant, indicating that these three assays may be analytically interchangeable. The relevance of the higher PD-L1-IC-positivity for SP263 should be further investigated.
Item Description:Gesehen am 18.03.2024
Physical Description:Online Resource
ISSN:1365-2559
DOI:10.1111/his.14254

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