Multicenter harmonization study for PD-L1 IHC testing in non-small-cell lung cancer |
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| Affiliation: | 1. Groupe PATTERN, Fondation Synergie Lyon Cancer, Lyon, France;2. Department of Biology and Pathology, Gustave Roussy, Villejuif, France;3. Department of Biopathology, Centre Léon Bérard, Lyon, France;4. Department of Pathology, Universitary Hospital, Toulouse, France;5. Universitary Center of Oncology of Toulouse, Toulouse, France;6. Department of Pathology, Hopital Bichat, Paris, France;7. Université Paris Diderot, Paris, France;8. Department of Patholog, Hôpital Européen Georges Pompidou, Assistance Publique-Hôpitaux de Paris, Paris, France;9. Université Paris Descartes, Paris, France;10. Departement de pathologie, Centre Jean Perrin, Clermont-Ferrand, France;11. Université d’Auvergne, Clermont-Ferrand, France;12. Department of Patholog, Hôpital Cochin, Assistance Publique-Hôpitaux de Paris, Paris, France;13. INSERM U1209/CNRS 530, Institute for Advanced Biosciences, Grenoble-Alpes University, Grenoble, France |
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| Abstract: | BackgroundVarious 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).MethodsIHC 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.Results28-8, 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.Conclusion28-8, 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. |
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