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Integration of Tumor Mutation Burden and PD-L1 Testing in Routine Laboratory Diagnostics in Non-Small Cell Lung Cancer
Open AccessArticle

Digital Pathology and PD-L1 Testing in Non Small Cell Lung Cancer: A Workshop Record

1
Department of Medicine and Surgery, Pathology, University Milan Bicocca, 20126 Milan, Italy
2
Department of Public Health, University of Naples Federico II, 80131 Naples, Italy
3
Pathology Unit, San Raffaele Hospital Scientific Institute, 20132 Milano, Italy
4
Department of Surgical, Medical, Molecular Pathology and Critical Area, Pisa University, 56126 Pisa, Italy
5
Pathology Unit, Azienda Ospedaliera per l’Emergenza Cannizzaro Hospital, 95126 Catania, Italy
6
Pathology Unit, Fondazione IRCCS Casa Sollievo della Sofferenza, San Giovanni Rotondo, 71013 Foggia, Italy
7
Center of Predictive Molecular Medicine, University-Foundation, 66100 Chieti, Italy
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Division of Pathology, IEO European Institute of Oncology IRCCS, 20141 Milan, Italy
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Department of Oncology and Hemato-Oncology, University of Milan, 20122 Milan, Italy
*
Author to whom correspondence should be addressed.
Equally contribution.
Cancers 2020, 12(7), 1800; https://doi.org/10.3390/cancers12071800
Received: 8 June 2020 / Revised: 2 July 2020 / Accepted: 3 July 2020 / Published: 5 July 2020
A meeting among expert pathologists was held in 2019 in Rome to verify the results of the previous harmonization efforts on the PD-L1 immunohistochemical testing by scoring a representative series of non-small cell lung cancer (NSCLC) digital slides. The current paper shows the results of this digital experimental meeting and the expertise achieved by the community of Italian pathologists. PD-L1 protein expression was determined using tumor proportion score (TPS), i.e., the percentage of viable tumor cells showing partial or complete membrane staining at any intensity. The gold standard was defined as the final PD-L1 score formulated by a panel of seven lung committed pathologists. PD-L1 status was clustered in three categories, namely negative (TPS < 1), low (TPS 1–49%), and high (TPS ≥ 50%). In 23 cases (71.9%) PD-L1 staining was performed using the companion diagnostic 22C3 pharmDx kit on Dako Autostainer, while in nine (28.1%) cases it was performed using the SP263 Ventana kit on BenchMark platform. A complete PD-L1 scoring agreement between the panel of experts and the participants was reached in 57.1% of cases, whereas a minor disagreement in 16.1% of cases was recorded. Italian pathologists performed best in strong positive cases (i.e., tumor proportion score TPS > 50%), whereas only 10.8% of disagreement with the gold standard was observed, and 55.6% regarded a single challenging case. The worst performance was achieved in the negative cases, with 32.0% disagreement. A significant difference resulted from the analysis of the data separated by the different clones used: 22.3% and 38.1% disagreement (p = 0.01) was found in the group of cases analyzed by 22C3 and SP263 antibody clones, respectively. In conclusion, this workshop record proposed the application of a digital pathology platform to share controversial cases in educational meetings as an alternative possibility for improving the interpretation and reporting of specific histological tools. Due to the crucial role of PD-L1 TPS for the selection of patients for immunotherapy, the identification of unconventional approaches as virtual slides to focus experiences and give more detailed practical verifications of the standard quality reached may be a considerable option. View Full-Text
Keywords: PD-L1; immunotherapy; NSCLC PD-L1; immunotherapy; NSCLC
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Pagni, F.; Malapelle, U.; Doglioni, C.; Fontanini, G.; Fraggetta, F.; Graziano, P.; Marchetti, A.; Guerini Rocco, E.; Pisapia, P.; Vigliar, E.V.; Buttitta, F.; Jaconi, M.; Fusco, N.; Barberis, M.; Troncone, G. Digital Pathology and PD-L1 Testing in Non Small Cell Lung Cancer: A Workshop Record. Cancers 2020, 12, 1800.

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