TY - JOUR
T1 - PD-L1 Immunohistochemistry Comparability Study in Real-Life Clinical Samples
T2 - Results of Blueprint Phase 2 Project
AU - Tsao, Ming Sound
AU - Kerr, Keith M.
AU - Kockx, Mark
AU - Beasley, Mary Beth
AU - Borczuk, Alain C.
AU - Botling, Johan
AU - Bubendorf, Lukas
AU - Chirieac, Lucian
AU - Chen, Gang
AU - Chou, Teh Ying
AU - Chung, Jin Haeng
AU - Dacic, Sanja
AU - Lantuejoul, Sylvie
AU - Mino-Kenudson, Mari
AU - Moreira, Andre L.
AU - Nicholson, Andrew G.
AU - Noguchi, Masayuki
AU - Pelosi, Giuseppe
AU - Poleri, Claudia
AU - Russell, Prudence A.
AU - Sauter, Jennifer
AU - Thunnissen, Erik
AU - Wistuba, Ignacio
AU - Yu, Hui
AU - Wynes, Murry W.
AU - Pintilie, Melania
AU - Yatabe, Yasushi
AU - Hirsch, Fred R.
N1 - Publisher Copyright:
© 2018 International Association for the Study of Lung Cancer
PY - 2018/9
Y1 - 2018/9
N2 - 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.
AB - 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.
KW - Checkpoint inhibitors
KW - Companion diagnostics
KW - Complementary diagnostics
KW - Cytology
KW - Immunooncology
KW - Pathology
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U2 - 10.1016/j.jtho.2018.05.013
DO - 10.1016/j.jtho.2018.05.013
M3 - Article
C2 - 29800747
AN - SCOPUS:85049880284
SN - 1556-0864
VL - 13
SP - 1302
EP - 1311
JO - Journal of Thoracic Oncology
JF - Journal of Thoracic Oncology
IS - 9
ER -
