Journal article
Intra- and interobserver reproducibility assessment of PD-L1 biomarker in non–small cell lung cancer
WA Cooper, PA Russell, M Cherian, EE Duhig, D Godbolt, PJ Jessup, C Khoo, C Leslie, A Mahar, DF Moffat, V Sivasubramaniam, C Faure, A Reznichenko, A Grattan, SB Fox
Clinical Cancer Research | AMER ASSOC CANCER RESEARCH | Published : 2017
Abstract
Purpose: Reliable and reproducible methods for identifying PD-L1 expression on tumor cells are necessary to identify responders to anti–PD-1 therapy. We tested the reproducibility of the assessment of PD-L1 expression in non–small cell lung cancer (NSCLC) tissue samples by pathologists. Experimental Design: NSCLC samples were stained with PD-L1 22C3 pharmDx kit using the Dako Autostainer Link 48 Platform. Two sample sets of 60 samples each were designed to assess inter- and intraobserver reproducibility considering two cut points for positivity: 1% or 50% of PD-L1 stained tumor cells. A randomization process was used to obtain equal distribution of PD-L1 positive and negative samples within ..
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Funding Acknowledgements
The study was funded by Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ USA.