PD-L1 immunohistochemistry in non-small-cell lung cancer: unraveling differences in staining concordance and interpretation.

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Abstrakt

Tytuł:: PD-L1 immunohistochemistry in non-small-cell lung cancer: unraveling differences in staining concordance and interpretation.
Autorzy:: Keppens C; Department of Public Health and Primary Care, Biomedical Quality Assurance Research Unit, University of Leuven, Leuven, Belgium.
Dequeker EM; Department of Public Health and Primary Care, Biomedical Quality Assurance Research Unit, University of Leuven, Leuven, Belgium.
Pauwels P; Center for Oncologic Research (CORE), University of Antwerp, Antwerp, Belgium.; Department of Pathology, University Hospital Antwerp, Edegem, Belgium.
Ryska A; Department of Pathology, Charles University Medical Faculty and University Hospital, Hradec Kralove, Czech Republic.
't Hart N; Department of Pathology, University Medical Center Groningen, Groningen, The Netherlands.; Department of Pathology, Isala Klinieken, Zwolle, The Netherlands.
von der Thüsen JH; Department of Pathology, University Medical Center Rotterdam, Erasmus MC, Rotterdam, The Netherlands. .
Źródło:: Virchows Archiv : an international journal of pathology [Virchows Arch] 2021 May; Vol. 478 (5), pp. 827-839. Date of Electronic Publication: 2020 Dec 04.
Typ publikacji:: Journal Article; Multicenter Study
Język:: English
Imprint Name(s):: Original Publication: Berlin ; New York : Springer International, c1994-
MeSH Terms:: Immunohistochemistry*
B7-H1 Antigen/*analysis
Biomarkers, Tumor/*analysis
Carcinoma, Non-Small-Cell Lung/*immunology
Lung Neoplasms/*immunology
Artifacts ; B7-H1 Antigen/antagonists & inhibitors ; Biomarkers, Tumor/antagonists & inhibitors ; Carcinoma, Non-Small-Cell Lung/drug therapy ; Carcinoma, Non-Small-Cell Lung/pathology ; Clinical Decision-Making ; Europe ; Humans ; Immune Checkpoint Inhibitors/therapeutic use ; Laboratory Proficiency Testing ; Lung Neoplasms/drug therapy ; Lung Neoplasms/pathology ; Observer Variation ; Predictive Value of Tests ; Reproducibility of Results ; Tissue Array Analysis
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Grant Information:: not applicable Pfizer Oncology; not applicable Bristol-Myers Squibb
Contributed Indexing:: Keywords: External quality assessment; Immunohistochemistry; PD-L1; Tumor proportion score
Substance Nomenclature:: 0 (B7-H1 Antigen)
0 (Biomarkers, Tumor)
0 (CD274 protein, human)
0 (Immune Checkpoint Inhibitors)
Entry Date(s):: Date Created: 20201204 Date Completed: 20210517 Latest Revision: 20210719
Update Code:: 20240104
PubMed Central ID:: PMC8099807
DOI:: 10.1007/s00428-020-02976-5
PMID:: 33275169
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Programmed death ligand 1 (PD-L1) immunohistochemistry (IHC) is accepted as a predictive biomarker for the selection of immune checkpoint inhibitors. We evaluated the staining quality and estimation of the tumor proportion score (TPS) in non-small-cell lung cancer during two external quality assessment (EQA) schemes by the European Society of Pathology. Participants received two tissue micro-arrays with three (2017) and four (2018) cases for PD-L1 IHC and a positive tonsil control, for staining by their routine protocol. After the participants returned stained slides to the EQA coordination center, three pathologists assessed each slide and awarded an expert staining score from 1 to 5 points based on the staining concordance. Expert scores significantly (p < 0.01) improved between EQA schemes from 3.8 (n = 67) to 4.3 (n = 74) on 5 points. Participants used 32 different protocols: the majority applied the 22C3 (56.7%) (Dako), SP263 (19.1%) (Ventana), and E1L3N (Cell Signaling) (7.1%) clones. Staining artifacts consisted mainly of very weak or weak antigen demonstration (63.0%) or excessive background staining (19.8%). Participants using CE-IVD kits reached a higher score compared with those using laboratory-developed tests (LDTs) (p < 0.05), mainly attributed to a better concordance of SP263. The TPS was under- and over-estimated in 20/423 (4.7%) and 24/423 (5.7%) cases, respectively, correlating to a lower expert score. Additional research is needed on the concordance of less common protocols, and on reasons for lower LDT concordance. Laboratories should carefully validate all test methods and regularly verify their performance. EQA participation should focus on both staining concordance and interpretation of PD-L1 IHC.

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