Gareth H Williams1, Andrew G Nicholson2, David R J Snead3, Erik Thunnissen4, Sylvie Lantuejoul5, Paul Cane6, Keith M Kerr7, Marco Loddo8, Marietta L J Scott9, Paul W Scorer9, Craig Barker9. 1. Oncologica UK Ltd., Cambridge, United Kingdom. Electronic address: gareth.williams@oncologica.com. 2. Royal Brompton and Harefield NHS Foundation Trust and National Heart and Lung Institute, Imperial College London, London, United Kingdom. 3. University Hospitals Coventry and Warwickshire NHS Trust, Coventry, United Kingdom. 4. VU University Medical Center Amsterdam, Amsterdam, The Netherlands. 5. Centre Léon Bérard UNICANCER and Grenoble Alpes University, Lyon, France. 6. Guy's and St Thomas' NHS Foundation Trust, London, United Kingdom. 7. Aberdeen University Medical School and Aberdeen Royal Infirmary, Aberdeen, United Kingdom. 8. Oncologica UK Ltd., Cambridge, United Kingdom. 9. Diagnostic Development Unit, Precision Medicine, R&D Oncology, AstraZeneca, Cambridge, United Kingdom.
Abstract
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 (R2 >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.
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 (R2 >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.
Authors: Saba Shafi; Thazin Nwe Aung; Charles Robbins; Jon Zugazagoitia; Ioannis Vathiotis; Niki Gavrielatou; Vesal Yaghoobi; Aileen Fernandez; Shuqiong Niu; Linda N Liu; Zachary T Cusumano; Nalin Leelatian; Kimberley Cole; He Wang; Robert Homer; Roy S Herbst; Sol Langermann; David L Rimm Journal: Lab Invest Date: 2022-04-22 Impact factor: 5.502
Authors: Florian Eichhorn; Mark Kriegsmann; Laura V Klotz; Katharina Kriegsmann; Thomas Muley; Christiane Zgorzelski; Petros Christopoulos; Hauke Winter; Martin E Eichhorn Journal: Cancers (Basel) Date: 2021-04-23 Impact factor: 6.639
Authors: Liesbeth M Hondelink; Melek Hüyük; Pieter E Postmus; Vincent T H B M Smit; Sami Blom; Jan H von der Thüsen; Danielle Cohen Journal: Histopathology Date: 2021-11-16 Impact factor: 7.778