Evidence map›Paper›PMID 29800747›Full record

Trial reportJournal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer2018

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

Ming Sound Tsao, Keith M Kerr, Mark Kockx, Mary-Beth Beasley, Alain C Borczuk, Johan Botling, Lukas Bubendorf, Lucian Chirieac, Gang Chen, Teh-Ying Chou and 18 more

Abstract readClinical Trial, Phase II
In one paragraph

Trial report in Journal of thoracic oncology : official publication of the International Association for the Study of Lung Cancer, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 410 papers, 10 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
410citing papers in PubMed, 10 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

410 citing papers in PubMed, 10 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Pooled it
  5. Pooled it
  6. Guideline
  7. Pooled it
  8. Pooled it
  9. Guideline
  10. Pooled it
  11. Trial
  12. Trial
  13. Trial
  14. Atezolizumab for Advanced Alveolar Soft Part Sarcoma.The New England journal of medicine · 2023
    Trial
  15. Trial
  16. Trial
  17. Trial
  18. Review
  19. Review
  20. PD-L1 PET/CT imaging withEuropean journal of nuclear medicine and molecular imaging · 2026
    Article

350 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

28 authors.

Ming Sound TsaoDepartment of Pathology, University Health Network/Princess Margaret Cancer Centre, University of Toronto, Toronto, Ontario, Canada.
Keith M KerrDepartment of Pathology, Aberdeen Royal Infirmary, Aberdeen University Medical School, Aberdeen, Scotland, United Kingdom.
Mark KockxHistoGeneX, Antwerp, Belgium.
Mary-Beth BeasleyDepartment of Pathology, Mount Sinai Medical Center, New York, New York.
Alain C BorczukDepartment of Pathology, Weill Cornell Medicine, New York, New York.
Johan BotlingDepartment of Immunology Genetics and Pathology, Science for Life Laboratory, Uppsala University, Uppsala, Sweden.
Lukas BubendorfInstitute of Pathology, University Hospital Basel, Pathologie, Basel, Switzerland.
Lucian ChirieacDepartment of Pathology, Brigham and Women's Hospital and Harvard Medical School, Boston, Massachusetts.
Gang ChenDepartment of Pathology, Zhongshan Hospital, Fudan University, Shanghai, People's Republic of China.
Teh-Ying ChouDivision of Molecular Pathology, Department of Pathology and Laboratory Medicine, Taipei Veterans General Hospital, Taipei, Republic of China.
Jin-Haeng ChungDepartment of Pathology and Respiratory Center, Seoul National University Bundang Hospital, Seongnam city, Gyeonggi-do, Republic of Korea.
Sanja DacicDepartment of Pathology University of Pittsburgh, Pittsburgh, Pennsylvania.
Sylvie LantuejoulDepartment of Biopathology, Centre Léon Bérard, Lyon, France.
Mari Mino-KenudsonDepartment of Pathology, Massachusetts General Hospital and Harvard Medical School, Boston, Massachusetts.
Andre L MoreiraNew York University Langone Health, Department of Pathology, New York, New York.
Andrew G NicholsonDepartment of Histopathology, Royal Brompton and Harefield National Health Service Foundation Trust and National Heart and Lung Institute, Imperial College, London, United Kingdom.
Masayuki NoguchiDepartment of Pathology, Faculty of Medicine, University of Tsukuba, Tsukuba, Japan.
Giuseppe PelosiDepartment of Oncology and Hemato-Oncology, University of Milan, and Istituto di Ricerca e Cura a Carattere Scientifico (IRCCS) Gruppo, MultiMedica, Milan, Italy.
Claudia PoleriOffice of Pathology Consultants, Buenos Aires, Argentina.
Prudence A RussellSt, Vincent's Pathology, Fitzroy, Victoria, Australia.
Jennifer SauterDepartment of Pathology, Memorial Sloan Kettering Cancer Center, New York, New York.
Erik ThunnissenDepartment of Pathology, VU University Medical Center, Amsterdam, the Netherlands.
Ignacio WistubaDepartment of Translational Molecular Pathology, M. D. Anderson Cancer Center, Houston, Texas.
Hui YuUniversity of Colorado Anschutz Medical Campus, Aurora, Colorado.
Murry W WynesInternational Association for the Study of Lung Cancer, Aurora, Colorado.
Melania PintilieDepartment of Biostatistics, University Health Network, Princess Margaret Cancer Centre Toronto, Ontario, Canada.
Yasushi YatabeDepartment of Pathology and Molecular Diagnostics, Aichi Cancer Center, Nagoya, Japan.
Fred R HirschUniversity of Colorado Anschutz Medical Campus, Aurora, Colorado; International Association for the Study of Lung Cancer, Aurora, Colorado. Electronic address: Fred.Hirsch@ucdenver.edu.

Funding

X-RAY CRYSTALLOGRAPHYP30CA008748 · NCI · SLOAN-KETTERING INSTITUTE FOR CANCER RES · PI Nicholas D Socci · 1985 to 2026
$347.4M
NCI NIH HHS P30 CA008748
6 · The paper itself

Abstract

objectivesThe 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.

methodsBP2 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.

resultsThe 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).

conclusionBP2 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.

Indexed as

B7-H1 AntigenHumansImmunohistochemistryB7-H1 AntigenCD274 protein, humanCheckpoint inhibitorsCompanion diagnosticsComplementary diagnosticsCytologyImmunooncologyPathology

Identifiers

PMID29800747
PMCPMC8386299

What OpenQuestion holds

Textmetadata
LicenceTDM
Read underepoch 390

Registered trials

None linked

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.