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Non-Small-Cell Lung Cancer Signaling Pathways, Metabolism, and PD-1/PD-L1 Antibodies
Open AccessArticle

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

1
Institut für Hämatopathologie Hamburg, Fangdieckstraße 75A, 22547 Hamburg, Germany
2
Lung Cancer Network NOWEL, 26129 Oldenburg, Germany
3
NEO New Oncology GmbH, Gottfried-Hagen-Straße 20, 51105 Cologne, Germany
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Department of Hematology and Oncology, Pius-Hospital Oldenburg, Georgstraße 12, 26121 Oldenburg, Germany
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Institute of Experimental Immunology and Hepatology, University Medical Center Hamburg Eppendorf, Martinistraße 52, 20246 Hamburg, Germany
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Department of Pulmonary Diseases, University of Groningen and University Medical Center Groningen, Hanzeplein 1, 9713 GZ Groningen, The Netherlands
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Onkologische Schwerpunktpraxis, Kröger Ambulante Onkologie, Wiener Straße 1, 27568 Bremerhaven, Germany
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Department of Internal Medicine and Pulmonology, Asklepios Klinikum Harburg, Eißendorfer Pferdeweg 52, 21075 Hamburg, Germany
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Department of Internal Medicine-Oncology, University of Oldenburg, Georgstraße 12, 26121 Oldenburg, Germany
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Germany Department of Thorax Oncology, Niels-Stensen-Kliniken, Franziskus-Hospital Harderberg Alte Rothenfelder Straße 23, 49124 Georgsmarienhütte, Germany
*
Author to whom correspondence should be addressed.
Authors contributed equally.
Cancers 2020, 12(6), 1685; https://doi.org/10.3390/cancers12061685
Received: 30 April 2020 / Revised: 18 June 2020 / Accepted: 20 June 2020 / Published: 24 June 2020
In recent years, Non-small cell lung cancer (NSCLC) has evolved into a prime example for precision oncology with multiple FDA-approved “precision” drugs. For the majority of NSCLC lacking targetable genetic alterations, immune checkpoint inhibition (ICI) has become standard of care in first-line treatment or beyond. PD-L1 tumor expression represents the only approved predictive biomarker for PD-L1/PD-1 checkpoint inhibition by therapeutic antibodies. Since PD-L1-negative or low-expressing tumors may also respond to ICI, additional factors are likely to contribute in addition to PD-L1 expression. Tumor mutation burden (TMB) has emerged as a potential candidate; however, it is the most complex biomarker so far and might represent a challenge for routine diagnostics. We therefore established a hybrid capture (HC) next-generation sequencing (NGS) assay that covers all oncogenic driver alterations as well as TMB and validated TMB values by correlation with the assay (F1CDx) used for the CheckMate 227 study. Results of the first consecutive 417 patients analyzed in a routine clinical setting are presented. Data show that fast reliable comprehensive diagnostics including TMB and targetable alterations are obtained with a short turn-around time. Thus, even complex biomarkers can easily be implemented in routine practice to optimize treatment decisions for advanced NSCLC. View Full-Text
Keywords: immuno-oncology; tumor mutational burden; lung cancer; routine diagnostics; driver mutation; PD-L1 immuno-oncology; tumor mutational burden; lung cancer; routine diagnostics; driver mutation; PD-L1
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Schatz, S.; Falk, M.; Jóri, B.; Ramdani, H.O.; Schmidt, S.; Willing, E.-M.; Menon, R.; Groen, H.J.M.; Diehl, L.; Kröger, M.; Wesseler, C.; Griesinger, F.; Hoffknecht, P.; Tiemann, M.; Heukamp, L.C. Integration of Tumor Mutation Burden and PD-L1 Testing in Routine Laboratory Diagnostics in Non-Small Cell Lung Cancer. Cancers 2020, 12, 1685.

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