Comparison of three PD-L1 immunohistochemical assays in head and neck squamous cell carcinoma (HNSCC)

Expression of programmed cell death-ligand 1 (PD-L1) is being used as predictive biomarker for immunotherapy in head and neck squamous cell carcinoma (HNSCC). Several antibodies are available for PD-L1 testing and multiple staining and scoring methods are used. This study aimed to compare the perfor...

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Veröffentlicht in:Modern pathology 2021-06, Vol.34 (6), p.1125-1132
Hauptverfasser: de Ruiter, Emma J., Mulder, Frans J., Koomen, Bregje M., Speel, Ernst-Jan, van den Hout, Mari F. C.M., de Roest, Reinout H., Bloemena, Elisabeth, Devriese, Lot A., Willems, Stefan M.
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container_end_page 1132
container_issue 6
container_start_page 1125
container_title Modern pathology
container_volume 34
creator de Ruiter, Emma J.
Mulder, Frans J.
Koomen, Bregje M.
Speel, Ernst-Jan
van den Hout, Mari F. C.M.
de Roest, Reinout H.
Bloemena, Elisabeth
Devriese, Lot A.
Willems, Stefan M.
description Expression of programmed cell death-ligand 1 (PD-L1) is being used as predictive biomarker for immunotherapy in head and neck squamous cell carcinoma (HNSCC). Several antibodies are available for PD-L1 testing and multiple staining and scoring methods are used. This study aimed to compare the performance of two PD-L1 standardized assays (SP263 and 22C3 pharmDx) and one laboratory-developed test (LDT) (22C3) in HNSCC using the tumor proportion score (TPS) and the combined positive score (CPS). Pretreatment biopsies from 147 HNSCC patients were collected in a tissue-microarray (TMA). Serial sections of the TMA were immunohistochemically stained for PD-L1 expression using 22C3 pharmDx on the Dako Link 48 platform, SP263 on the Ventana Benchmark Ultra platform, and 22C3 as an LDT on the Ventana Benchmark Ultra. Stained slides were assessed for TPS and CPS. Cutoffs of ≥1% and ≥50% for TPS and ≥1 and ≥20 for CPS were used. Concordance between the different staining assays was moderate to poor for TPS (intraclass correlation coefficient (ICC) 0.46) as well as for CPS (ICC 0.34). When stratifying patients by clinically relevant cutoffs, considerable differences between the assays were observed: concordance was poor for both TPS and CPS. Generally, SP263 stained a higher percentage of cells than the other assays, especially when using the CPS. Moderate concordance was shown between three different PD-L1 immunohistochemical assays and considerable differences in PD-L1 positivity were observed when using clinically relevant cutoffs. This should be taken into account when using PD-L1 expression to guide clinical practice.
doi_str_mv 10.1038/s41379-020-0644-7
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subjects 13/1
13/51
631/67/1536
692/53/2423
Adult
Aged
Antibodies
Apoptosis
Automation
B7-H1 Antigen - analysis
Biomarkers
Biomarkers, Tumor - analysis
Biopsy
Cancer
Cell death
Clinical trials
Cohort Studies
FDA approval
Female
Head & neck cancer
Humans
Immunohistochemistry - methods
Immunotherapy
Laboratories
Laboratory Medicine
Ligands
Male
Medicine
Medicine & Public Health
Metastasis
Middle Aged
Pathology
Patients
PD-L1 protein
Retrospective Studies
Squamous cell carcinoma
Squamous Cell Carcinoma of Head and Neck - metabolism
Squamous Cell Carcinoma of Head and Neck - pathology
title Comparison of three PD-L1 immunohistochemical assays in head and neck squamous cell carcinoma (HNSCC)
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