Journal
JOURNAL OF THORACIC ONCOLOGY
Volume 15, Issue 4, Pages 550-555Publisher
ELSEVIER SCIENCE INC
DOI: 10.1016/j.jtho.2019.11.010
Keywords
Assay reliability; Immunohistochemistry; Interobserver concordance; Programmed cell death ligand-1; SP263
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Funding
- AstraZeneca
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Introduction: The VENTANA PD-L1 (SP263) Assay is approved for use with anti-programmed cell death-1/programmed cell death ligand-1 (PD-1/PD-L1) therapies in NSCLC and urothelial carcinoma. Here, we investigate interobserver reliability of the SP263 assay, applied to PD-L1 scoring of tumor cells (TCs) in NSCLC. Methods: Six practicing European pulmonary pathologists independently scored the proportion of TCs expressing PD-L1 (TC score) from 200 archival, commercially sourced, formalin-fixed paraffin-embedded NSCLC resections stained using the SP263 assay. Agreement in scores was analyzed using the intraclass correlation coefficient and concordance in patient's classification using Fleiss' kappa. Results: Results from 172 samples showed strong pair-wise correlations between pathologists (R-2 > 0.89) for TC scoring with an intraclass correlation coefficient of 0.96. Overall agreement was greater than 90% for TC of 1% and above, and greater than 94% for TCs of at least 25% and at least 50%. Fleiss' kappa showed substantial agreement for TC of 1% and above, and almost perfect agreement for TCs of at least 25% and at least 50%. Conclusions: Assessment of TC score in NSCLC was highly reproducible using the SP263 assay, building confidence in the accuracy of this assay in selection of patients for anti-PD-1/PD-L1 therapy. (C) 2019 International Association for the Study of Lung Cancer. Published by Elsevier Inc.
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