ArticleApplied immunohistochemistry & molecular morphology : AIMM
Fit-For-Purpose PD-L1 Biomarker Testing For Patient Selection in Immuno-Oncology: Guidelines For Clinical Laboratories From the Canadian Association of Pathologists-Association Canadienne Des Pathologistes (CAP-ACP).
Article in Applied immunohistochemistry & molecular morphology : AIMM. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 26 papers, 1 of them a synthesis that pooled 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.
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.
Who cites it
26 citing papers in PubMed, 1 synthesis or guideline pooled it, 55 citations in OpenAlex.
- PD-L1 testing in urothelial bladder cancer: essentials of clinical practice.World journal of urology · 2021Pooled it
- Zolbetuximab or Immunotherapy as the Initial Targeted Therapy in CLDN18.2-Positive, HER2-Negative Advanced Gastric Cancer: Weighing the Options.Current oncology (Toronto, Ont.) · 2025Review
- Immunohistochemistry in intrahepatic cholangiocarcinoma: histological subtyping and drug selection.Frontiers in oncology · 2025Review
- Canadian Consensus Recommendations for Predictive Biomarker Testing in Gastric and Gastroesophageal Junction Adenocarcinoma.Current oncology (Toronto, Ont.) · 2024Review
- Consensus Statement: Recommendations on Actionable Biomarker Testing for Thyroid Cancer Management.Endocrine pathology · 2024Article
- Report from the 25th Annual Western Canadian Gastrointestinal Cancer Consensus Conference on Gastric and Gastroesophageal Cancers, Winnipeg, Manitoba, 26-27 October 2023.Current oncology (Toronto, Ont.) · 2024Article
- Pathologic assessment of hepatocellular carcinoma in the era of immunotherapy: a narrative review.Hepatobiliary surgery and nutrition · 2024Review
- Further knowledge and developments in resistance mechanisms to immune checkpoint inhibitors.Frontiers in immunology · 2024Review
- Programmed death ligand 1 expression in diffuse large B cell lymphoma: correlation with clinicopathological prognostic factors.Journal of the Egyptian National Cancer Institute · 2023Article
- New update to the guidelines on testing predictive biomarkers in non-small-cell lung cancer: a National Consensus of the Spanish Society of Pathology and the Spanish Society of Medical Oncology.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2023Article
- PD-L1 testing by immunohistochemistry in immuno-oncology.Biomolecules & biomedicine · 2023Review
- Immunohistochemical Study of Bladder Cancer Molecular Subtypes and Their Association with PD-L1 Expression.Cancers · 2022Article
- Handling and standardization of EBUS needle aspiration in NSCLC patients: The value of the cell block, a monoinstitutional experience.Thoracic cancer · 2022Article
- Atlas of PD-L1 for Pathologists: Indications, Scores, Diagnostic Platforms and Reporting Systems.Journal of personalized medicine · 2022Review
- A digital assay for programmed death-ligand 1 (22C3) quantification combined with immune cell recognition algorithms in non-small cell lung cancer.Scientific reports · 2022Article
- Immunoexpression of PD-L1 and PD-1 and Its Clinicopathological Correlation in Urothelial Carcinomas.Journal of laboratory physicians · 2022Article
- Targeting immune checkpoints in gynecologic cancer: updates & perspectives for pathologists.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2022Review
- PD-L1 Testing in Urothelial Carcinoma: Analysis of a Series of 1401 Cases Using Both the 22C3 and SP142 Assays.Pathology oncology research : POR · 2022Article
- Emerging Biomarkers in Thyroid Practice and Research.Cancers · 2021Review
- PD-L1 and beyond: Immuno-oncology in cytopathology.Cytopathology : official journal of the British Society for Clinical Cytology · 2021Review
Corrections and comments
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Authors and funding
30 authors at 12 institutions in 7 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Since 2014, programmed cell death protein 1 (PD-1)/programmed cell death ligand 1 (PD-L1) checkpoint inhibitors have been approved by various regulatory agencies for the treatment of multiple cancers including melanoma, lung cancer, urothelial carcinoma, renal cell carcinoma, head and neck cancer, classical Hodgkin lymphoma, colorectal cancer, gastroesophageal cancer, hepatocellular cancer, and other solid tumors. Of these approved drug/disease combinations, a subset also has regulatory agency-approved, commercially available companion/complementary diagnostic assays that were clinically validated using data from their corresponding clinical trials. The objective of this document is to provide evidence-based guidance to assist clinical laboratories in establishing fit-for-purpose PD-L1 biomarker assays that can accurately identify patients with specific tumor types who may respond to specific approved immuno-oncology therapies targeting the PD-1/PD-L1 checkpoint. These recommendations are issued as 38 Guideline Statements that address (i) assay development for surgical pathology and cytopathology specimens, (ii) reporting elements, and (iii) quality assurance (including validation/verification, internal quality assurance, and external quality assurance). The intent of this work is to provide recommendations that are relevant to any tumor type, are universally applicable and can be implemented by any clinical immunohistochemistry laboratory performing predictive PD-L1 immunohistochemistry testing.
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What OpenQuestion holds
Registered trials
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.