PD-L1 testing of non-small cell lung cancer using different antibodies and platforms: a Swiss cross-validation study.

Détails

ID Serval
serval:BIB_119D11D55F85
Type
Article: article d'un périodique ou d'un magazine.
Collection
Publications
Titre
PD-L1 testing of non-small cell lung cancer using different antibodies and platforms: a Swiss cross-validation study.
Périodique
Virchows Archiv
Auteur(s)
Savic S., Berezowska S., Eppenberger-Castori S., Cathomas G., Diebold J., Fleischmann A., Jochum W., Komminoth P., McKee T., Letovanec I., Jasarevic Z., Rössle M., Singer G., von Gunten M., Zettl A., Zweifel R., Soltermann A., Bubendorf L.
ISSN
1432-2307 (Electronic)
ISSN-L
0945-6317
Statut éditorial
Publié
Date de publication
07/2019
Peer-reviewed
Oui
Volume
475
Numéro
1
Pages
67-76
Langue
anglais
Notes
Publication types: Comparative Study ; Journal Article ; Multicenter Study ; Validation Studies
Publication Status: ppublish
Résumé
With the approval of pembrolizumab for first- and second-line treatment of PD-L1+ non-small cell lung cancer (NSCLC), PD-L1 testing by immunohistochemistry (IHC) has become a necessity. However, the DAKO autostainer ASL48 for the FDA approved DAKO 22C3 pharmDx assay is not broadly available in Switzerland and other parts of Europe. The primary goal of this study was to cross-validate the 22C3 anti-PD-L1 antibody on Benchmark Ultra (VBMU) and Leica Bond (LBO) immunostainers. IHC protocols were developed for 22C3 on both platforms with the 22C3phDx using ASL48 as reference. A tissue microarray (TMA) was constructed from 23 NSCLC specimens with a range of PD-L1 staining results. Empty TMA sections and the 22C3 antibody were distributed to 16 participants for staining on VBMU (8 centers) and/or LBO (12 centers) using the centrally developed protocols. Additionally the performance of the Ventana SP263 assay was tested in five centers. IHC scoring was performed centrally. Categorical PD-L1 staining (0-49% vs. 50-100%) did not significantly differ between centers using VBMU, whereas data from LBO were highly variable (p < 0.001). The SP263 assay was well concordant with 22C3 on VBMU and with 22C3 pharmDx. PD-L1 IHC using a standardized 22C3 protocol on VBMU provides satisfactory results in most centers. The SP263 assay is confirmed as a valid alternative to 22C3 pharmDx. 22C3 PD-L1 IHC on LBO shows major staining variability between centers, highlighting the need for local validation and adjustment of protocols.
Mots-clé
Antibodies/immunology, Automation, Laboratory, B7-H1 Antigen/analysis, Biomarkers, Tumor/analysis, Carcinoma, Non-Small-Cell Lung/chemistry, Carcinoma, Non-Small-Cell Lung/immunology, Carcinoma, Non-Small-Cell Lung/pathology, Humans, Immunohistochemistry/instrumentation, Immunohistochemistry/methods, Immunohistochemistry/standards, Lung Neoplasms/chemistry, Lung Neoplasms/immunology, Lung Neoplasms/pathology, Observer Variation, Predictive Value of Tests, Reproducibility of Results, Switzerland, Tissue Array Analysis, 22C3, Immunohistochemistry, Non-small cell lung carcinoma, PD-L1, SP263
Pubmed
Web of science
Création de la notice
29/05/2019 14:22
Dernière modification de la notice
20/08/2019 13:39
Données d'usage