Scheel, Andreas H., Baenfer, Gudrun, Baretton, Gustavo, Dietel, Manfred, Diezko, Rolf, Henkel, Thomas, Heukamp, Lukas C., Jasani, Bharat, Joehrens, Korinna, Kirchner, Thomas, Lasitschka, Felix, Petersen, Iver, Reu, Simone, Schildhaus, Hans-Ulrich, Schirmacher, Peter, Schwamborn, Kristina, Sommer, Ulrich, Stoss, Oliver, Tiemann, Markus, Warth, Arne, Weichert, Wilko, Wolf, Juergen, Buettner, Reinhard and Rueschoff, Josef (2018). Interlaboratory concordance of PD-L1 immunohistochemistry for non-small-cell lung cancer. Histopathology, 72 (3). S. 449 - 460. HOBOKEN: WILEY. ISSN 1365-2559

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Abstract

AimsProgrammed death ligand 1 (PD-L1) immunohistochemistry has become a mandatory diagnostic test in the treatment of lung cancer. Several research initiatives have started to harmonise the five PD-L1 immunohistochemistry assays that have been used in clinical trials. Here, we report data on interlaboratory and interassay concordance for commercial assays (assays') and laboratory-developed tests (LDTs) at 10 German testing sites. Methods and resultsTo assess interlaboratory concordance, a tissue microarray containing 21 pulmonary carcinoma specimens was centrally prepared. Pre-cut sections were stained at 10 sites by the use of assays 28-8, 22C3, SP263, and SP142, as well as 11 LDTs. Assay performance was evaluated with a second tissue microarray containing 11 cell lines with defined PD-L1 expression. Quality control was centrally performed by manual and digital analyses. The assays yielded reproducible IHC staining patterns at all sites. In agreement with previous studies, 22C3, 28-8 and SP263 showed similar staining patterns, whereas SP142 was distinct. Among the LDTs, six of 11 protocols showed staining patterns similar to those of assays 22C3 and 28-8. Interlaboratory concordance of tumour cell scoring by use of a six-step system was moderate (Light's = 0.43-0.69), whereas the clinically approved cut-offs of 1% and 50% showed substantial concordance ( = 0.73-0.89). Immune cell scoring by the use of SP142 yielded moderate concordance ( = 0.42). ConclusionsThe data confirm the previously described staining patterns of the assays, and show that they can be reproducibly employed at different sites. LDTs with staining results similar to those of the assays are implementable, but have to be carefully validated.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Scheel, Andreas H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baenfer, GudrunUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baretton, GustavoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dietel, ManfredUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Diezko, RolfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Henkel, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heukamp, Lukas C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jasani, BharatUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Joehrens, KorinnaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kirchner, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lasitschka, FelixUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Petersen, IverUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reu, SimoneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schildhaus, Hans-UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schirmacher, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schwamborn, KristinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sommer, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stoss, OliverUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Tiemann, MarkusUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Warth, ArneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Weichert, WilkoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wolf, JuergenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Buettner, ReinhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rueschoff, JosefUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-196470
DOI: 10.1111/his.13375
Journal or Publication Title: Histopathology
Volume: 72
Number: 3
Page Range: S. 449 - 460
Date: 2018
Publisher: WILEY
Place of Publication: HOBOKEN
ISSN: 1365-2559
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
SQUAMOUS-CELL; OPEN-LABEL; DOCETAXEL; BLOCKADE; PEMBROLIZUMAB; ATEZOLIZUMAB; MULTICENTER; NIVOLUMAB; ASSAYSMultiple languages
Cell Biology; PathologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/19647

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