PD-L1 diagnostic tests: a systematic literature review of scoring algorithms and test-validation metrics
Autor: | Maria Rizzo, SueAnn Dahm, Jim P. Doherty, Juliet Kenny, Eric Faulkner, Margarita Udall, Paul B. Robbins |
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Rok vydání: | 2018 |
Předmět: |
PD-L1
0301 basic medicine Test Lung Neoplasms Histology Concordance medicine.medical_treatment Programmed Cell Death 1 Receptor MEDLINE Context (language use) Review B7-H1 Antigen Pathology and Forensic Medicine 03 medical and health sciences 0302 clinical medicine PD-1 Biomarkers Tumor lcsh:Pathology medicine Animals Humans Diagnostic Programmed death ligand 1 Lung cancer Antibody Cancer Programmed cell death protein 1 Diagnostic Tests Routine business.industry Tests Antibodies Monoclonal General Medicine Immunotherapy medicine.disease Clinical trial 030104 developmental biology Systematic review 030220 oncology & carcinogenesis business Algorithm Algorithms lcsh:RB1-214 |
Zdroj: | Diagnostic Pathology, Vol 13, Iss 1, Pp 1-11 (2018) Diagnostic Pathology |
ISSN: | 1746-1596 |
Popis: | Background The programmed death receptor 1 (PD-1) protein is a cell-surface receptor on certain lymphocytes that, with its ligand programmed death ligand 1 (PD-L1), helps to down-regulate immune responses. Many cancer types express PD-L1 and evade immune recognition via the PD-1/PD-L1 interaction. Precision therapies targeting the PD-1/PD-L1 pathway have the potential to improve response and thereby offer a novel treatment avenue to some patients with cancer. However, this new therapeutic approach requires reliable methods for identifying patients whose cancers are particularly likely to respond. Therefore, we conducted a systematic literature review assessing evidence on test validation and scoring algorithms for PD-L1 immunohistochemistry (IHC) tests that might be used to select potentially responsive patients with bladder/urothelial cell, lung, gastric, or ovarian cancers for immunotherapy treatment. Methods and results To identify evidence on commercially available PD-L1 IHC assays, we systematically searched MEDLINE and Embase for relevant studies published between January 2010 and September 2016 and appraised abstracts from recent oncology conferences (January 2013 to November 2016). Publications that met the predefined inclusion criteria were extracted and key trends summarized. In total, 26 eligible primary studies were identified, all of which reported on the test validation metrics associated with PD-L1 IHC tests in lung cancer, most using immunohistochemistry testing. There was significant heterogeneity among the available tests for PD-L1. Specifically, no definitive cutoff for PD-L1 positivity was identifiable, with more than one threshold being reported for most antibodies. Studies also differed as to whether they evaluated tumor cells only or tumor cells and tumor-infiltrating immune cells. However, all of the tests developed and validated to support a therapeutic drug in the context of phase 2–3 clinical trials reported more than 90% inter-reader concordance. In contrast, other PD-L1 antibodies identified in the literature reported poorer concordance. Conclusions Published validation metric data for PD-L1 tests are mainly focused on immunohistochemistry tests from studies in lung cancer. The variability in test cutoffs and standards for PD-L1 testing suggests that there is presently no standardized approach. This current variability may have implications for the uptake of precision treatments. |
Databáze: | OpenAIRE |
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