Abstract
Aims: Programmed 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 results: To 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 κ = 0.43–0.69), whereas the clinically approved cut-offs of ≥1% and ≥50% showed substantial concordance (κ = 0.73–0.89). Immune cell scoring by the use of SP142 yielded moderate concordance (κ = 0.42). Conclusions: The 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.
| Original language | English |
|---|---|
| Pages (from-to) | 449-459 |
| Number of pages | 11 |
| Journal | Histopathology |
| Volume | 72 |
| Issue number | 3 |
| DOIs | |
| Publication status | Published - Feb 1 2018 |
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Keywords
- CD274 antigens
- immunohistochemistry
- immunotherapy
- non-small-cell lung carcinoma
ASJC Scopus subject areas
- Pathology and Forensic Medicine
- Histology
Cite this
Interlaboratory concordance of PD-L1 immunohistochemistry for non-small-cell lung cancer. / Scheel, Andreas H.; Baenfer, Gudrun; Baretton, Gustavo; Dietel, Manfred; Diezko, Rolf; Henkel, Thomas; Heukamp, Lukas C.; Jasani, Bharat; Jöhrens, 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, Jürgen; Büttner, Reinhard; Rüschoff, Josef.
In: Histopathology, Vol. 72, No. 3, 01.02.2018, p. 449-459.Research output: Contribution to journal › Article
}
TY - JOUR
T1 - Interlaboratory concordance of PD-L1 immunohistochemistry for non-small-cell lung cancer
AU - Scheel, Andreas H.
AU - Baenfer, Gudrun
AU - Baretton, Gustavo
AU - Dietel, Manfred
AU - Diezko, Rolf
AU - Henkel, Thomas
AU - Heukamp, Lukas C.
AU - Jasani, Bharat
AU - Jöhrens, Korinna
AU - Kirchner, Thomas
AU - Lasitschka, Felix
AU - Petersen, Iver
AU - Reu, Simone
AU - Schildhaus, Hans Ulrich
AU - Schirmacher, Peter
AU - Schwamborn, Kristina
AU - Sommer, Ulrich
AU - Stoss, Oliver
AU - Tiemann, Markus
AU - Warth, Arne
AU - Weichert, Wilko
AU - Wolf, Jürgen
AU - Büttner, Reinhard
AU - Rüschoff, Josef
PY - 2018/2/1
Y1 - 2018/2/1
N2 - Aims: Programmed 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 results: To 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 κ = 0.43–0.69), whereas the clinically approved cut-offs of ≥1% and ≥50% showed substantial concordance (κ = 0.73–0.89). Immune cell scoring by the use of SP142 yielded moderate concordance (κ = 0.42). Conclusions: The 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.
AB - Aims: Programmed 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 results: To 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 κ = 0.43–0.69), whereas the clinically approved cut-offs of ≥1% and ≥50% showed substantial concordance (κ = 0.73–0.89). Immune cell scoring by the use of SP142 yielded moderate concordance (κ = 0.42). Conclusions: The 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.
KW - CD274 antigens
KW - immunohistochemistry
KW - immunotherapy
KW - non-small-cell lung carcinoma
UR - http://www.scopus.com/inward/record.url?scp=85034619177&partnerID=8YFLogxK
UR - http://www.scopus.com/inward/citedby.url?scp=85034619177&partnerID=8YFLogxK
U2 - 10.1111/his.13375
DO - 10.1111/his.13375
M3 - Article
VL - 72
SP - 449
EP - 459
JO - Histopathology
JF - Histopathology
SN - 0309-0167
IS - 3
ER -