PD-L1 Immunohistochemistry Comparability Study in Real-Life Clinical Samples: Results of Blueprint Phase 2 Project.
- Tsao MS Department of Pathology, University Health Network/Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.
- Kerr KM Department of Pathology, Aberdeen Royal Infirmary, Aberdeen University Medical School, Aberdeen, Scotland, United Kingdom.
- Kockx M HistoGeneX, Antwerp, Belgium.
- Beasley MB Department of Pathology, Mount Sinai Medical Center, New York, New York.
- Borczuk AC Department of Pathology, Weill Cornell Medicine, New York, New York.
- Botling J Department of Immunology Genetics and Pathology, Science for Life Laboratory, Uppsala University, Uppsala, Sweden.
- Bubendorf L Institute of Pathology, University Hospital Basel, Pathologie, Basel, Switzerland.
- Chirieac L Department of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
- Chen G Department of Pathology, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.
- Chou TY Division of Molecular Pathology, Department of Pathology and Laboratory Medicine, Taipei Veterans General Hospital, Taipei, Republic of China.
- Chung JH Department of Pathology and Respiratory Center, Seoul National University Bundang Hospital, Seongnam city, Gyeonggi-do, Republic of Korea.
- Dacic S Department of Pathology University of Pittsburgh, Pittsburgh, Pennsylvania.
- Lantuejoul S Department of Biopathology, Centre Léon Bérard, Lyon, France.
- Mino-Kenudson M Department of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
- Moreira AL New York University Langone Health, Department of Pathology, New York, New York.
- Nicholson AG Department of Histopathology, Royal Brompton and Harefield National Health Service Foundation Trust and National Heart and Lung Institute, Imperial College, London, United Kingdom.
- Noguchi M Department of Pathology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
- Pelosi G Department of Oncology and Hemato-Oncology, University of Milan, and Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS) Gruppo, MultiMedica, Milan, Italy.
- Poleri C Office of Pathology Consultants, Buenos Aires, Argentina.
- Russell PA St, Vincent's Pathology, Fitzroy, Victoria, Australia.
- Sauter J Department of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
- Thunnissen E Department of Pathology, VU University Medical Center, Amsterdam, the Netherlands.
- Wistuba I Department of Translational Molecular Pathology, M. D. Anderson Cancer Center, Houston, Texas.
- Yu H University of Colorado Anschutz Medical Campus, Aurora, Colorado.
- Wynes MW International Association for the Study of Lung Cancer, Aurora, Colorado.
- Pintilie M Department of Biostatistics, University Health Network, Princess Margaret Cancer Centre Toronto, Ontario, Canada.
- Yatabe Y Department of Pathology and Molecular Diagnostics, Aichi Cancer Center, Nagoya, Japan.
- Hirsch FR University of Colorado Anschutz Medical Campus, Aurora, Colorado; International Association for the Study of Lung Cancer, Aurora, Colorado. Electronic address: Fred.Hirsch@ucdenver.edu.
- 2018-05-26
Published in:
- Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer. - 2018
Checkpoint inhibitors
Companion diagnostics
Complementary diagnostics
Cytology
Immunooncology
Pathology
B7-H1 Antigen
Humans
Immunohistochemistry
English
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.
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.
- Language
-
- English
- Open access status
- bronze
- Identifiers
-
- DOI 10.1016/j.jtho.2018.05.013
- PMID 29800747
- Persistent URL
- https://sonar.ch/global/documents/264310
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