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Tytuł pozycji:

Multicentre study on the consistency of PD-L1 immunohistochemistry as predictive test for immunotherapy in non-small cell lung cancer.

Tytuł:
Multicentre study on the consistency of PD-L1 immunohistochemistry as predictive test for immunotherapy in non-small cell lung cancer.
Autorzy:
Butter R; Department of Pathology, Cancer Center Amsterdam, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands .
't Hart NA; Department of Pathology and Medical Biology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
Hooijer GKJ; Department of Pathology, Cancer Center Amsterdam, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.
Monkhorst K; Department of Pathology, The Netherlands Cancer Institute, Antoni van Leeuwenhoek Hospital, Amsterdam, The Netherlands.
Speel EJ; Department of Pathology, GROW-School for Oncology and Developmental Biology, Maastricht University Medical Center, Maastricht, The Netherlands.
Theunissen P; Department of Pathology, Zuyderland Medical Center, Heerlen, The Netherlands.
Thunnissen E; Department of Pathology, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Von der Thüsen JH; Department of Pathology, Erasmus University Medical Center, Erasmus University Rotterdam, Rotterdam, The Netherlands.
Timens W; Department of Pathology and Medical Biology, University Medical Center Groningen, University of Groningen, Groningen, The Netherlands.
van de Vijver MJ; Department of Pathology, Cancer Center Amsterdam, Amsterdam University Medical Centers, University of Amsterdam, Amsterdam, The Netherlands.; Department of Pathology, Cancer Center Amsterdam, Amsterdam University Medical Centers, Vrije Universiteit Amsterdam, Amsterdam, The Netherlands.
Źródło:
Journal of clinical pathology [J Clin Pathol] 2020 Jul; Vol. 73 (7), pp. 423-430. Date of Electronic Publication: 2019 Dec 10.
Typ publikacji:
Journal Article; Multicenter Study
Język:
English
Imprint Name(s):
Publication: London : BMJ Pub. Group
Original Publication: London : British Medical Association
MeSH Terms:
B7-H1 Antigen/*metabolism
Carcinoma, Non-Small-Cell Lung/*therapy
Lung Neoplasms/*pathology
Carcinoma, Non-Small-Cell Lung/metabolism ; Carcinoma, Non-Small-Cell Lung/pathology ; Epitopes/metabolism ; Humans ; Immunohistochemistry ; Immunotherapy ; Lung/pathology ; Lung Neoplasms/metabolism ; Observer Variation ; Pathologists ; Predictive Value of Tests ; Tissue Array Analysis
Contributed Indexing:
Keywords: histopathology; immunohistochemistry; lung cancer; oncology; pulmonary pathology
Substance Nomenclature:
0 (B7-H1 Antigen)
0 (CD274 protein, human)
0 (Epitopes)
Entry Date(s):
Date Created: 20191212 Date Completed: 20200706 Latest Revision: 20200706
Update Code:
20240105
DOI:
10.1136/jclinpath-2019-205993
PMID:
31822512
Czasopismo naukowe
Aims: Investigate the impact of interlaboratory- and interobserver variability of immunohistochemistry on the assessment of programmed death ligand 1 (PD-L1) in non-small cell lung cancer (NSCLC).
Methods: Two tissue microarrays (TMAs) were constructed from 50 (TMA-A) and 51 (TMA-B) resected NSCLC cases, and distributed among eight centres. Immunostaining for PD-L1 was performed using Agilent's 22C3 pharmDx Assay (pharmDx) and/or a 22C3 laboratory developed test (LDT). The interlaboratory variability of staining- and interobserver variability of scoring for PD-L1 were assessed in selected critical samples (samples at the cut-off of positivity) and non-critical samples. Also, PD-L1 epitope deterioration in time in stored unstained slides was analysed. Krippendorff's alpha values (0=maximal, 1=no variability) were calculated as measure for variability.
Results: For interlaboratory variability of immunostaining, the percentage of PD-L1 positive cases among centres ranged 40%-51% (1% cut-off) and 23%-30% (50% cut-off). Alpha values at 1% cut-off were 0.88 (pharmDx) and 0.87 (LDT) and at 50% cut-off 0.82 (pharmDx) and 0.95 (LDT). Interobserver variability of scoring resulted in PD-L1 positive cases ranging 29%-55% (1% cut-off) and 14%-30% (50% cut-off) among pathologists. Alpha values were at 1% cut-off 0.83 (TMA-A) and 0.66 (TMA-B), and at 50% cut-off 0.77 (TMA-A) and 0.78 (TMA-B). Interlaboratory variability of staining was higher (p<0.001) in critical samples than in non-critical samples at 50% cut-off. Furthermore, PD-L1 epitope deterioration in unstained slides was observed after 12 weeks.
Conclusions: The results provide insight in factors contributing to variability of immunohistochemical assessment of PD-L1, and contribute to more reliable predictive testing for PD-L1.
Competing Interests: Competing interests: RB: none. N‘tH: MSD (unrestricted grant), Pfizer (personal fee). KM: Roche (research grant, personal fee), MSD (research grant, personal fee), Astra Zeneca (research grant, personal fee), Pfizer (personal fee), Benecke (personal fee), BMS (personal fee), Abbvie (personal fee), Diaceutics (personal fee). E-JS: MSD (research grant, personal fee), BMS (research grant, personal fee), Novartis (research grant), AstraZeneca (research grant), AbbVie (personal fee), Bayer (personal fee), Roche (personal fee). ET: HistoGeneX (personal fee), Roche Diagnostics (personal fee). JHVdT: Astellas (research grant), BMS (research grant, personal fee), AbbVie (personal fee), Astra Zeneca (personal fee), Boehringer-Ingelheim (personal fee), BMS (personal fee), Eli Lilly (personal fee), MSD (personal fee), Pfizer (personal fee), Roche (personal fee). WT: MSD (personal fee), Roche-Ventana (personal fee), Pfizer (personal fee), Astra Zeneca (personal fee), GSK (personal fee), Chiesi (personal fee), Dutch Asthma Fund (research grant), Biotest (personal fee), Novartis (personal fee), Lilly Oncology (personal fee), Boehringer Ingelheim (personal fee). MJvdV: MSD (research grant), Roche (personal fee).
(© Author(s) (or their employer(s)) 2020. No commercial re-use. See rights and permissions. Published by BMJ.)

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