Andréanne Gagné1, Emily Wang1, Nathalie Bastien2, Michèle Orain1, Patrice Desmeules3, Sylvain Pagé2, Sylvain Trahan4, Christian Couture5, David Joubert6, Philippe Joubert7. 1. Quebec City Heart and Lung Institute Research Center, Quebec City, Canada. 2. Department of Pathology, Quebec City Heart and Lung Institute, Quebec City, Canada. 3. Quebec City Heart and Lung Institute Research Center, Quebec City, Canada; Department of Pathology, Quebec City Heart and Lung Institute, Quebec City, Canada. 4. Department of Pathology, Quebec City Heart and Lung Institute, Quebec City, Canada; Department of Molecular Biology, Medical Biochemistry and Pathology, Laval University, Quebec City, Canada. 5. Quebec City Heart and Lung Institute Research Center, Quebec City, Canada; Department of Pathology, Quebec City Heart and Lung Institute, Quebec City, Canada; Department of Molecular Biology, Medical Biochemistry and Pathology, Laval University, Quebec City, Canada. 6. Faculty of Social Sciences, University of Ottawa, Ottawa, Canada. 7. Quebec City Heart and Lung Institute Research Center, Quebec City, Canada; Department of Pathology, Quebec City Heart and Lung Institute, Quebec City, Canada; Department of Molecular Biology, Medical Biochemistry and Pathology, Laval University, Quebec City, Canada. Electronic address: philippe.joubert.1@ulaval.ca.
Abstract
INTRODUCTION: Molecules targeting programmed cell death 1 or its ligand programmed death ligand 1 (PD-L1) revolutionized the treatment of patients with NSCLC. The only approved biomarker for predicting treatment response is the PD-L1 tumor proportion score (TPS) determined by immunohistochemistry. According to International Association for the Study of Lung Cancer recommendations, specimens that include fewer than 100 tumor cells or are older than 3 years should not be used for PD-L1 testing and the reliability of cell blocks has yet to be validated. METHODS: This retrospective study included 1249 consecutive patients with NSCLC who were tested for PD-L1 (using the clone 22C3) between September 2016 and April 2017. The associations between the presence of suboptimal characteristics (specimens with <100 tumor cells, specimens older than 3 years, or cell blocks) and PD-L1 TPS were examined by using a multinomial logistic regression. RESULTS: Specimens from 35.5% of the patients had at least one suboptimal characteristic. For patients with a PD-L1 TPS of higher than 50%, there was a significantly higher probability that they had a specimen with more than 100 tumor cells (OR = 1.97, p = 0.008) and a more recent block (within 30 days versus after >3 years) (OR = 2.46, p = 0.023). There was no statistical difference in PD-L1 TPS between cell blocks and tissue specimens (biopsy OR = 0.99 [p = 0.996] and surgery OR = 0.73 [p = 0.302]). CONCLUSIONS: Our results suggest that specimens containing fewer than 100 tumor cells or older than 3 years may lead to an underestimation of PD-L1 status. Our findings also provide support for the use of cell blocks for PD-L1 testing, although further research is needed.
INTRODUCTION: Molecules targeting programmed cell death 1 or its ligand programmed death ligand 1 (PD-L1) revolutionized the treatment of patients with NSCLC. The only approved biomarker for predicting treatment response is the PD-L1 tumor proportion score (TPS) determined by immunohistochemistry. According to International Association for the Study of Lung Cancer recommendations, specimens that include fewer than 100 tumor cells or are older than 3 years should not be used for PD-L1 testing and the reliability of cell blocks has yet to be validated. METHODS: This retrospective study included 1249 consecutive patients with NSCLC who were tested for PD-L1 (using the clone 22C3) between September 2016 and April 2017. The associations between the presence of suboptimal characteristics (specimens with <100 tumor cells, specimens older than 3 years, or cell blocks) and PD-L1 TPS were examined by using a multinomial logistic regression. RESULTS: Specimens from 35.5% of the patients had at least one suboptimal characteristic. For patients with a PD-L1 TPS of higher than 50%, there was a significantly higher probability that they had a specimen with more than 100 tumor cells (OR = 1.97, p = 0.008) and a more recent block (within 30 days versus after >3 years) (OR = 2.46, p = 0.023). There was no statistical difference in PD-L1 TPS between cell blocks and tissue specimens (biopsy OR = 0.99 [p = 0.996] and surgery OR = 0.73 [p = 0.302]). CONCLUSIONS: Our results suggest that specimens containing fewer than 100 tumor cells or older than 3 years may lead to an underestimation of PD-L1 status. Our findings also provide support for the use of cell blocks for PD-L1 testing, although further research is needed.
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