Frank Griesinger1, Wilfried Eberhardt2, Arnd Nusch3, Marcel Reiser4, Mark-Oliver Zahn5, Christoph Maintz6, Christiane Bernhardt7, Christoph Losem8, Albrecht Stenzinger9, Lukas C Heukamp10, Reinhard Büttner11, Norbert Marschner12, Martina Jänicke13, Annette Fleitz13, Lisa Spring13, Jörg Sahlmann14, Aysun Karatas15, Annette Hipper15, Wilko Weichert16, Monika Heilmann17, Parvis Sadjadian18, Wolfgang Gleiber19, Christian Grah20, Cornelius F Waller21, Martin Reck22, Achim Rittmeyer23, Petros Christopoulos24, Martin Sebastian25, Michael Thomas24. 1. Pius-Hospital Oldenburg, Universitätsklinik für Innere Medizin, Oldenburg, Germany. Electronic address: Frank.Griesinger@Pius-Hospital.de. 2. Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätszentrum Essen, Germany. 3. Praxis für Hämatologie und internistische Onkologie, Ratingen, Germany. 4. PIOH - Praxis internistische Onkologie und Hämatologie, Köln, Germany. 5. MVZ Onkologische Kooperation Harz, Goslar, Germany. 6. Hämatologie-Onkologie, MVZ West GmbH Würselen, Germany. 7. Gemeinschaftspraxis für Hämatologie und Onkologie, Dortmund, Germany. 8. MVZ für Onkologie und Hämatologie im Rhein-Kreis, Neuss, Germany. 9. Institute of Pathology, University Hospital Heidelberg, Heidelberg, Germany. 10. Hämatopathologie Hamburg, Hamburg, Germany; Lungen Netzwerk NOWEL.org, Oldenburg, Germany. 11. Institut für Pathologie des Universitätsklinikums Köln, Köln, Germany. 12. Praxis für interdisziplinäre Onkologie und Hämatologie, Freiburg, Germany. 13. Clinical Epidemiology and Health Economics, iOMEDICO, Freiburg, Germany. 14. Biostatistics, iOMEDICO, Freiburg, Germany. 15. AIO-Studien-gGmbH, Berlin, Germany. 16. Institut für Pathologie, Technische Universität München und German Cancer Consortium (DKTK), partner site Munich, München, Germany. 17. Lungenkrebszentrum, KRH Klinikum Siloah, Hannover, Germany. 18. Universitätsklinik für Hämatologie, Onkologie, Hämostaseologie und Palliativmedizin, Johannes Wesling Klinikum, Universitätsklinikum der Ruhr Universität Bochum, Minden, Germany. 19. Universitätsklinikum Frankfurt, Medizinische Klinik I, Schwerpunkt Pneumologie/Allergologie, Frankfurt, Germany. 20. MVZ Havelhöhe am Gemeinschaftskrankenhaus Havelhöhe, Berlin, Germany. 21. Medizinische Klinik I, Hämatologie, Onkologie und Stammzelltransplantation; Fakultät für Medizin, Universitätsklinikum Freiburg, Germany. 22. LungenClinic, Airway Research Center North, German Center for Lung Research, Grosshansdorf, Germany. 23. Lungenfachklinik Immenhausen, Germany. 24. Onkologie der Thoraxtumore, Thoraxklinik Heidelberg gGmbH, German Center for Lung Research (DZL), Germany. 25. Medizinische Klinik II, Hämatologie/Onkologie, Universitätsklinikum Frankfurt, Germany.
Abstract
OBJECTIVES: An increasing number of treatment-determining biomarkers has been identified in non-small cell lung cancer (NSCLC) and molecular testing is recommended to enable optimal individualized treatment. However, data on implementation of these recommendations in the "real-world" setting are scarce. This study presents comprehensive details on the frequency, methodology and results of biomarker testing of advanced NSCLC in Germany. PATIENTS AND METHODS: This analysis included 3,717 patients with advanced NSCLC (2,921 non-squamous; 796 squamous), recruited into the CRISP registry at start of systemic therapy by 150 German sites between December 2015 and June 2019. Evaluated were the molecular biomarkers EGFR, ALK, ROS1, BRAF, KRAS, MET, TP53, RET, HER2, as well as expression of PD-L1. RESULTS: In total, 90.5 % of the patients were tested for biomarkers. Testing rates were 92.2 % (non-squamous), 70.7 % (squamous) and increased from 83.2 % in 2015/16 to 94.2% in 2019. Overall testing rates for EGFR, ALK, ROS1, and BRAF were 72.5 %, 74.5 %, 66.1 %, and 53.0 %, respectively (non-squamous). Testing rates for PD-L1 expression were 64.5 % (non-squamous), and 58.5 % (squamous). The most common testing methods were immunohistochemistry (68.5 % non-squamous, 58.3 % squamous), and next-generation sequencing (38.7 % non-squamous, 14.4 % squamous). Reasons for not testing were insufficient tumor material or lack of guideline recommendations (squamous). No alteration was found in 37.8 % (non-squamous), and 57.9 % (squamous), respectively. Most common alterations in non-squamous tumors (all patients/all patients tested for the respective biomarker): KRAS (17.3 %/39.2 %), TP53 (14.1 %/51.4 %), and EGFR (11.0 %/15.1 %); in squamous tumors: TP53 (7.0 %/69.1 %), MET (1.5 %/11.1 %), and EGFR (1.1 %/4.4 %). Median PFS (non-squamous) was 8.7 months (95 % CI 7.4-10.4) with druggable EGFR mutation, and 8.0 months (95 % CI 3.9-9.2) with druggable ALK alterations. CONCLUSION: Testing rates in Germany are high nationwide and acceptable in international comparison, but still leave out a significant portion of patients, who could potentially benefit. Thus, specific measures are needed to increase implementation.
OBJECTIVES: An increasing number of treatment-determining biomarkers has been identified in non-small cell lung cancer (NSCLC) and molecular testing is recommended to enable optimal individualized treatment. However, data on implementation of these recommendations in the "real-world" setting are scarce. This study presents comprehensive details on the frequency, methodology and results of biomarker testing of advanced NSCLC in Germany. PATIENTS AND METHODS: This analysis included 3,717 patients with advanced NSCLC (2,921 non-squamous; 796 squamous), recruited into the CRISP registry at start of systemic therapy by 150 German sites between December 2015 and June 2019. Evaluated were the molecular biomarkers EGFR, ALK, ROS1, BRAF, KRAS, MET, TP53, RET, HER2, as well as expression of PD-L1. RESULTS: In total, 90.5 % of the patients were tested for biomarkers. Testing rates were 92.2 % (non-squamous), 70.7 % (squamous) and increased from 83.2 % in 2015/16 to 94.2% in 2019. Overall testing rates for EGFR, ALK, ROS1, and BRAF were 72.5 %, 74.5 %, 66.1 %, and 53.0 %, respectively (non-squamous). Testing rates for PD-L1 expression were 64.5 % (non-squamous), and 58.5 % (squamous). The most common testing methods were immunohistochemistry (68.5 % non-squamous, 58.3 % squamous), and next-generation sequencing (38.7 % non-squamous, 14.4 % squamous). Reasons for not testing were insufficient tumor material or lack of guideline recommendations (squamous). No alteration was found in 37.8 % (non-squamous), and 57.9 % (squamous), respectively. Most common alterations in non-squamous tumors (all patients/all patients tested for the respective biomarker): KRAS (17.3 %/39.2 %), TP53 (14.1 %/51.4 %), and EGFR (11.0 %/15.1 %); in squamous tumors: TP53 (7.0 %/69.1 %), MET (1.5 %/11.1 %), and EGFR (1.1 %/4.4 %). Median PFS (non-squamous) was 8.7 months (95 % CI 7.4-10.4) with druggable EGFR mutation, and 8.0 months (95 % CI 3.9-9.2) with druggable ALK alterations. CONCLUSION: Testing rates in Germany are high nationwide and acceptable in international comparison, but still leave out a significant portion of patients, who could potentially benefit. Thus, specific measures are needed to increase implementation.
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