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PD-L1 Immunohistochemistry Comparability Study in Real-Life Clinical Samples: Results of Blueprint Phase 2 Project

Open access
Tsao, Ming Sound, Kerr, Keith M., Kockx, Mark, Beasley, Mary-Beth, Borczuk, Alain C., Botling, Johan, Bubendorf, Lukas, Chirieac, Lucian, Chen, Gang, Chou, Teh-Ying, Chung, Jin-Haeng, Dacic, Sanja, Lantuejoul, Sylvie, Mino-Kenudson, Mari, Moreira, Andre L., Nicholson, Andrew G., Noguchi, Masayuki, Pelosi, Giuseppe, Poleri, Claudia, Russell, Prudence A., Sauter, Jennifer, Thunnissen, Erik, Wistuba, Ignacio, Yu, Hui, Wynes, Murry W., Pintilie, Melania, Yatabe, Yasushi, Hirsch, Fred R.·2018·Journal of Thoracic Oncology
DOI 10.1016/j.jtho.2018.05.013
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Abstract

Objectives: The Blueprint (BP) Programmed Death Ligand 1 (PD‐L1) Immunohistochemistry Comparability Project is a pivotal academic/professional society and industrial collaboration to assess the feasibility of harmonizing the clinical use of five independently developed commercial PD‐L1 immunohistochemistry assays. The goal of BP phase 2 (BP2) was to validate the results obtained in BP phase 1 by using real‐world clinical lung cancer samples. Methods: BP2 were conducted using 81 lung cancer specimens of various histological and sample types, stained with all five trial‐validated PD‐L1 assays (22C3, 28‐8, SP142, SP263, and 73‐10); the slides were evaluated by an international panel of pathologists. BP2 also assessed the reliability of PD‐L1 scoring by using digital images, and samples prepared for cytological examination. PD‐L1 expression was assessed for percentage (tumor proportional score) of tumor cell (TC) and immune cell areas showing PD‐L1 staining, with TCs scored continuously or categorically with the cutoffs used in checkpoint inhibitor trials. Results: The BP2 results showed highly comparable staining by the 22C3, 28‐8 and SP263 assays; less sensitivity with the SP142 assay; and higher sensitivity with the 73‐10 assay to detect PD‐L1 expression on TCs. Glass slide and digital image scorings were highly concordant (Pearson correlation >0.96). There was very strong reliability among pathologists in TC PD‐L1 scoring with all assays (overall intraclass correlation coefficient [ICC] = 0.86–0.93), poor reliability in IC PD‐L1 scoring (overall ICC = 0.18–0.19), and good agreement in assessing PD‐L1 status on cytological cell block materials (ICC = 0.78–0.85). Conclusion: BP2 consolidates the analytical evidence for interchangeability of the 22C3, 28‐8, and SP263 assays and lower sensitivity of the SP142 assay for determining tumor proportion score on TCs and demonstrates greater sensitivity of the 73‐10 assay compared with that of the other assays.

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Research works printed but not linked: 20

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Metadata

Authors
Tsao, M. S., Kerr, K. M., Kockx, M., Beasley, M.-B., Borczuk, A. C., Botling, J., Bubendorf, L., Chirieac, L., Chen, G., Chou, T.-Y., Chung, J.-H., Dacic, S., Lantuejoul, S., Mino-Kenudson, M., Moreira, A. L., Nicholson, A. G., Noguchi, M., Pelosi, G., Poleri, C., Russell, P. A., Sauter, J., Thunnissen, E., Wistuba, I., Yu, H., Wynes, M. W., Pintilie, M., Yatabe, Y., & Hirsch, F. R.
Venue
Journal of Thoracic Oncology
Publisher
Elsevier BV
Published
2018-09
Volume
13
Issue
9
Pages
1302-1311
ISSN
1556-0864 (ISSN-L)
DOI
10.1016/j.jtho.2018.05.013
OpenAlex
W2804957255
Cited by
794
References
2
FWCI
36.40
Type
journal article
Language
en
Open access
bronze
Licence
Funders
IHC

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Tsao, M. S., Kerr, K. M., Kockx, M., Beasley, M.-B., Borczuk, A. C., Botling, J., Bubendorf, L., Chirieac, L., Chen, G., Chou, T.-Y., Chung, J.-H., Dacic, S., Lantuejoul, S., Mino-Kenudson, M., Moreira, A. L., Nicholson, A. G., Noguchi, M., Pelosi, G., Poleri, C., . . . Hirsch, F. R. (2018). PD-L1 Immunohistochemistry Comparability Study in Real-Life Clinical Samples: Results of Blueprint Phase 2 Project. Journal of Thoracic Oncology. https://doi.org/10.1016/j.jtho.2018.05.013

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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.

Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).

Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.