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PMID: 29800747 Published · ppublish English Clinical Trial, Phase II Journal Article Research Support, Non-U.S. Gov't

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

Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer ·Vol. 13 ·No. 9 ·2018-00-00 ·Pages 1302-1311

Tsao MS, Kerr KM, Kockx M, Beasley MB, Borczuk AC, Botling J, Bubendorf L, Chirieac L, Chen G, Chou TY, Chung JH, Dacic S, Lantuejoul S, Mino-Kenudson M, Moreira AL, Nicholson AG, Noguchi M, Pelosi G, Poleri C, Russell PA, Sauter J, Thunnissen E, Wistuba I, Yu H, Wynes MW, Pintilie M, Yatabe Y, Hirsch FR

Abstract

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. 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. 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). 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.

Keywords
Checkpoint inhibitors Companion diagnostics Complementary diagnostics Cytology Immunooncology Pathology
MeSH Terms
B7-H1 Antigen/immunology Humans Immunohistochemistry/methods
Chemicals
B7-H1 Antigen CD274 protein, human
Authors & Affiliations
28 authors, click to expand affiliations / ORCID
Tsao Ming Sound
Department of Pathology, University Health Network/Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.
Kerr Keith M
Department of Pathology, Aberdeen Royal Infirmary, Aberdeen University Medical School, Aberdeen, Scotland, United Kingdom.
Kockx Mark
HistoGeneX, Antwerp, Belgium.
Beasley Mary-Beth
Department of Pathology, Mount Sinai Medical Center, New York, New York.
Borczuk Alain C
Department of Pathology, Weill Cornell Medicine, New York, New York.
Botling Johan
Department of Immunology Genetics and Pathology, Science for Life Laboratory, Uppsala University, Uppsala, Sweden.
Bubendorf Lukas
Institute of Pathology, University Hospital Basel, Pathologie, Basel, Switzerland.
Chirieac Lucian
Department of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Chen Gang
Department of Pathology, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.
Chou Teh-Ying
Division of Molecular Pathology, Department of Pathology and Laboratory Medicine, Taipei Veterans General Hospital, Taipei, Republic of China.
Chung Jin-Haeng
Department of Pathology and Respiratory Center, Seoul National University Bundang Hospital, Seongnam city, Gyeonggi-do, Republic of Korea.
Dacic Sanja
Department of Pathology University of Pittsburgh, Pittsburgh, Pennsylvania.
Lantuejoul Sylvie
Department of Biopathology, Centre Léon Bérard, Lyon, France.
Mino-Kenudson Mari
Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Moreira Andre L
New York University Langone Health, Department of Pathology, New York, New York.
Nicholson Andrew G
Department of Histopathology, Royal Brompton and Harefield National Health Service Foundation Trust and National Heart and Lung Institute, Imperial College, London, United Kingdom.
Noguchi Masayuki
Department of Pathology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Pelosi Giuseppe
Department of Oncology and Hemato-Oncology, University of Milan, and Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS) Gruppo, MultiMedica, Milan, Italy.
Poleri Claudia
Office of Pathology Consultants, Buenos Aires, Argentina.
Russell Prudence A
St, Vincent's Pathology, Fitzroy, Victoria, Australia.
Sauter Jennifer
Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
Thunnissen Erik
Department of Pathology, VU University Medical Center, Amsterdam, the Netherlands.
Wistuba Ignacio
Department of Translational Molecular Pathology, M. D. Anderson Cancer Center, Houston, Texas.
Yu Hui
University of Colorado Anschutz Medical Campus, Aurora, Colorado.
Wynes Murry W
International Association for the Study of Lung Cancer, Aurora, Colorado.
Pintilie Melania
Department of Biostatistics, University Health Network, Princess Margaret Cancer Centre Toronto, Ontario, Canada.
Yatabe Yasushi
Department of Pathology and Molecular Diagnostics, Aichi Cancer Center, Nagoya, Japan.
Hirsch Fred R
University of Colorado Anschutz Medical Campus, Aurora, Colorado; International Association for the Study of Lung Cancer, Aurora, Colorado. Electronic address: Fred.Hirsch@ucdenver.edu.
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Article Info
Journal
Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer
Abbr.
J Thorac Oncol
ISSN
1556-1380
DOI
10.1016/j.jtho.2018.05.013
Email
fred.hirsch@ucdenver.edu
Published
2018-00-00
Epub
2018-00-22
Pages
1302-1311
Language
English
Region
United States
NLM ID
101274235
PMCID
PMC8386299
Subset
IM
Grants
NCI NIH HHS · P30 CA008748 · United States
Corrections
CommentIn
PMID: 30166010
External Links
PubMed source DOI: 10.1016/j.jtho.2018.05.013 PMC Full Text View journal details
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