cad a22 4500 569306922 CHVBK 20200702111107.0 cr unu---uuuuu 190726e20190524xx s 000 0 eng 10.1007/s00428-019-02582-0 doi 10.5167/uzh-171737 doi (ZORA)oai:www.zora.uzh.ch:171737 (SERVAL)BIB_119D11D55F85 610 ddc 31127385 pmid 000474496100007 isiid PD-L1 testing of non-small cell lung cancer using different antibodies and platforms: a Swiss cross-validation study [Elektronische Daten] [Spasenija Savic, Sabina Berezowska, Serenella Eppenberger-Castori, Gieri Cathomas, Joachim Diebold, Achim Fleischmann, Wolfram Jochum, Paul Komminoth, Thomas McKee, Igor Letovanec, Zerina Jasarevic, Matthias Rössle, Gad Singer, Michael von Gunten, Andreas Zettl, Roland Zweifel, Alex Soltermann, Lukas Bubendorf] closedAccess eu-repo 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. Institute of Pathology and Molecular Pathology zora Savic Spasenija joint author Berezowska Sabina joint author Eppenberger-Castori Serenella joint author Cathomas Gieri joint author Diebold Joachim joint author Fleischmann Achim joint author Jochum Wolfram joint author Komminoth Paul joint author McKee Thomas joint author Letovanec Igor joint author Jasarevic Zerina joint author Rössle Matthias joint author Singer Gad joint author von Gunten Michael joint author Zettl Andreas joint author Zweifel Roland joint author Soltermann Alex joint author Bubendorf Lukas joint author Virchows Archiv 475(1):67-76 https://www.zora.uzh.ch/id/eprint/171737/1/Savic_Virchows_Archiv_2019.pdf text/html WWW-Backlink auf das Repository BK010053 XK010053 XK010000 1 Journal Article PeerReviewed zora ZORA ZORA ZORA Journal Article closedAccess SERVAL SERVAL SERVAL article ZORA 856 40 https://www.zora.uzh.ch/id/eprint/171737/1/Savic_Virchows_Archiv_2019.pdf text/html WWW-Backlink auf das Repository ZORA 700 1- Savic Spasenija joint author ZORA 700 1- Berezowska Sabina joint author ZORA 700 1- Eppenberger-Castori Serenella joint author ZORA 700 1- Cathomas Gieri joint author ZORA 700 1- Diebold Joachim joint author ZORA 700 1- Fleischmann Achim joint author ZORA 700 1- Jochum Wolfram joint author ZORA 700 1- Komminoth Paul joint author ZORA 700 1- McKee Thomas joint author ZORA 700 1- Letovanec Igor joint author ZORA 700 1- Jasarevic Zerina joint author ZORA 700 1- Rössle Matthias joint author ZORA 700 1- Singer Gad joint author ZORA 700 1- von Gunten Michael joint author ZORA 700 1- Zettl Andreas joint author ZORA 700 1- Zweifel Roland joint author ZORA 700 1- Soltermann Alex joint author ZORA 700 1- Bubendorf Lukas joint author ZORA 773 0- Virchows Archiv 475(1):67-76 SERVAL 700 1- Savic S. aut SERVAL 700 1- Berezowska S. aut SERVAL 700 1- Eppenberger-Castori S. aut SERVAL 700 1- Cathomas G. aut SERVAL 700 1- Diebold J. aut SERVAL 700 1- Fleischmann A. aut SERVAL 700 1- Jochum W. aut SERVAL 700 1- Komminoth P. aut SERVAL 700 1- McKee T. aut SERVAL 700 1- Letovanec I. aut SERVAL 700 1- Jasarevic Z. aut SERVAL 700 1- Rössle M. aut SERVAL 700 1- Singer G. aut SERVAL 700 1- von Gunten M. aut SERVAL 700 1- Zettl A. aut SERVAL 700 1- Zweifel R. aut SERVAL 700 1- Soltermann A. aut SERVAL 700 1- Bubendorf L. aut SERVAL 773 0- Virchows Archiv 475/1(2019-07), 67-76 475:1<67-76 2019 475