J Adam1, N Le Stang2, I Rouquette3, A Cazes4, C Badoual5, H Pinot-Roussel5, L Tixier6, C Danel7, F Damiola2, D Damotte8, F Penault-Llorca6, S Lantuéjoul9. 1. Groupe PATTERN, Fondation Synergie Lyon Cancer, Lyon, France; Department of Biology and Pathology, Gustave Roussy, Villejuif, France. 2. Department of Biopathology, Centre Léon Bérard, Lyon, France. 3. Groupe PATTERN, Fondation Synergie Lyon Cancer, Lyon, France; Department of Pathology, Universitary Hospital, Toulouse, France; Universitary Center of Oncology of Toulouse, Toulouse, France. 4. Groupe PATTERN, Fondation Synergie Lyon Cancer, Lyon, France; Department of Pathology, Hopital Bichat, Paris, France; Université Paris Diderot, Paris, France. 5. Groupe PATTERN, Fondation Synergie Lyon Cancer, Lyon, France; Department of Patholog, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France; Université Paris Descartes, Paris, France. 6. Groupe PATTERN, Fondation Synergie Lyon Cancer, Lyon, France; Departement de pathologie, Centre Jean Perrin, Clermont-Ferrand, France; Université d'Auvergne, Clermont-Ferrand, France. 7. Groupe PATTERN, Fondation Synergie Lyon Cancer, Lyon, France; Department of Pathology, Hopital Bichat, Paris, France. 8. Groupe PATTERN, Fondation Synergie Lyon Cancer, Lyon, France; Université Paris Descartes, Paris, France; Department of Patholog, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France. 9. Groupe PATTERN, Fondation Synergie Lyon Cancer, Lyon, France; Department of Biopathology, Centre Léon Bérard, Lyon, France; INSERM U1209/CNRS 530, Institute for Advanced Biosciences, Grenoble-Alpes University, Grenoble, France. Electronic address: sylvie.lantuejoul@lyon.unicancer.fr.
Abstract
Background: Various programed death ligand 1 (PD-L1) immunohistochemistry (IHC) assays have been developed and used in clinical trials in association with different drugs. In order to harmonize and make PD-L1 testing in non-small-cell lung cancer (NSCLC) widely available, we conducted a multicenter study comparing PD-L1 standardized assays and laboratory-developed tests (LDTs). Methods: IHC with five anti-PD-L1 monoclonal antibodies (28-8, 22C3, E1L3N, SP142 and SP263) was performed concomitantly on 41 NSCLC surgical specimens in 7 centers using Dako Autostainer Link 48 (3 centers), Leica Bond (2 centers) or Ventana BenchMark Ultra (2 centers) platforms. For each matching platform, 22C3, 28-8 and SP263 assays were performed. For nonmatching platforms and other antibodies, LDTs were developed in each center. A total of 35 stainings were performed for each case across different platforms and antibodies. PD-L1 staining was assessed in tumor cells and immune cells by seven trained thoracic pathologists. For statistical analysis, 1%, 50% and 1%, 5%, 10% expression thresholds were used for tumor cells and immune cells, respectively. Results: 28-8, 22C3 and SP263 assays were highly concordant for tumor cells staining across the five Dako or Ventana platforms. Among 27 LDTs developed in 7 centers on Dako, Ventana and Leica platforms, 14 (51.8%) demonstrated similar concordance when compared with reference assays for tumor cell staining. Clone SP263 achieved the highest concordance rate across all platforms. Lower concordance was observed for immune cells staining when using a four categories scale. Conclusion: 28-8, 22C3 and SP263 assays had close analytical performance for tumor cell staining across seven centers. Some LDTs on Dako, Ventana and Leica platforms achieved similar concordance, but caution is warranted for their validation. These LDTs will be further validated in order to provide recommendations for the use of assays and LDT for PD-L1 testing in NSCLC.
Background: Various programed death ligand 1 (PD-L1) immunohistochemistry (IHC) assays have been developed and used in clinical trials in association with different drugs. In order to harmonize and make PD-L1 testing in non-small-cell lung cancer (NSCLC) widely available, we conducted a multicenter study comparing PD-L1 standardized assays and laboratory-developed tests (LDTs). Methods: IHC with five anti-PD-L1 monoclonal antibodies (28-8, 22C3, E1L3N, SP142 and SP263) was performed concomitantly on 41 NSCLC surgical specimens in 7 centers using Dako Autostainer Link 48 (3 centers), Leica Bond (2 centers) or Ventana BenchMark Ultra (2 centers) platforms. For each matching platform, 22C3, 28-8 and SP263 assays were performed. For nonmatching platforms and other antibodies, LDTs were developed in each center. A total of 35 stainings were performed for each case across different platforms and antibodies. PD-L1 staining was assessed in tumor cells and immune cells by seven trained thoracic pathologists. For statistical analysis, 1%, 50% and 1%, 5%, 10% expression thresholds were used for tumor cells and immune cells, respectively. Results: 28-8, 22C3 and SP263 assays were highly concordant for tumor cells staining across the five Dako or Ventana platforms. Among 27 LDTs developed in 7 centers on Dako, Ventana and Leica platforms, 14 (51.8%) demonstrated similar concordance when compared with reference assays for tumor cell staining. Clone SP263 achieved the highest concordance rate across all platforms. Lower concordance was observed for immune cells staining when using a four categories scale. Conclusion: 28-8, 22C3 and SP263 assays had close analytical performance for tumor cell staining across seven centers. Some LDTs on Dako, Ventana and Leica platforms achieved similar concordance, but caution is warranted for their validation. These LDTs will be further validated in order to provide recommendations for the use of assays and LDT for PD-L1 testing in NSCLC.
Authors: Francesco Pierconti; Maria Rosaria Raspollini; Maurizio Martini; Luigi Maria Larocca; Pier Francesco Bassi; Riccardo Bientinesi; Gianna Baroni; Andrea Minervini; Guido Petracco; Giacomo Maria Pini; Carlo Patriarca Journal: Virchows Arch Date: 2020-02-07 Impact factor: 4.064
Authors: Juan Ruiz-Bañobre; María C Areses-Manrique; Joaquín Mosquera-Martínez; Alexandra Cortegoso; Francisco J Afonso-Afonso; Noemí de Dios-Álvarez; Natalia Fernández-Núñez; Cristina Azpitarte-Raposeiras; Margarita Amenedo; Lucía Santomé; José Luis Fírvida-Pérez; Rosario García-Campelo; Jorge García-González; Joaquín Casal-Rubio; Sergio Vázquez Journal: Transl Lung Cancer Res Date: 2019-12