Evaluation of the effectiveness of a nationwide precision medicine program for patients with advanced non-small cell lung cancer in Germany: a historical cohort analysis

Anika Kästner; Anna Kron; Neeltje van den Berg; Kilson Moon; Matthias Scheffler; Gerhard Schillinger; Natalie Pelusi; Nils Hartmann; Damian Tobias Rieke; Susann Stephan-Falkenau; Martin Schuler; Martin Wermke; Wilko Weichert; Frederick Klauschen; Florian Haller; Horst-Dieter Hummel; Martin Sebastian; Stefan Gattenlöhner; Carsten Bokemeyer; Irene Esposito; Florian Jakobs; Christof von Kalle; Reinhard Büttner; Jürgen Wolf; Wolfgang Hoffmann

doi:10.1016/j.lanepe.2023.100788

Evaluation of the effectiveness of a nationwide precision medicine program for patients with advanced non-small cell lung cancer in Germany: a historical cohort analysis

Lancet Reg Health Eur. 2023 Nov 22:36:100788. doi: 10.1016/j.lanepe.2023.100788. eCollection 2024 Jan.

Authors

Anika Kästner¹, Anna Kron^{2

3}, Neeltje van den Berg¹, Kilson Moon¹, Matthias Scheffler^{2

3}, Gerhard Schillinger⁴, Natalie Pelusi^{2

5}, Nils Hartmann^{2

6}, Damian Tobias Rieke^{2

7}, Susann Stephan-Falkenau^{2

8}, Martin Schuler^{2

9}, Martin Wermke^{2

10}, Wilko Weichert^{2

11}, Frederick Klauschen^{2

12}, Florian Haller^{2

13}, Horst-Dieter Hummel^{2

14}, Martin Sebastian^{2

15}, Stefan Gattenlöhner^{2

16}, Carsten Bokemeyer^{2

17}, Irene Esposito^{2

18}, Florian Jakobs^{2

19}, Christof von Kalle^{2

20}, Reinhard Büttner^{2

21}, Jürgen Wolf^{2

3}, Wolfgang Hoffmann¹

Affiliations

¹ Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Greifswald, Germany.
² National Network Genomic Medicine Lung Cancer, Germany.
³ Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Lung Cancer Group Cologne, University Hospital of Cologne, Cologne, Germany.
⁴ Federal Association of the AOK, Berlin, Germany.
⁵ Institute of Pathology, University Hospital Bonn, Bonn, Germany.
⁶ Institute of Pathology, University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany.
⁷ Charité Comprehensive Cancer Center, Charité Universitätsmedizin Berlin, Berlin, Germany.
⁸ Institute of Pathology, Helios Klinikum Emil von Behring, Berlin, Germany.
⁹ West German Cancer Center, University Hospital Essen, Essen, Germany.
¹⁰ Clinic for Internal Medicine I, University Hospital Carl Gustav Carus and Medical Faculty of the TU Dresden, Dresden, Germany.
¹¹ Institute of Pathology, Technical University of Munich (TUM), Munich, Germany.
¹² Institute of Pathology, Ludwig-Maximilians-University (LMU), Munich, Germany.
¹³ Institute of Pathology, Friedrich-Alexander University Erlangen-Nuremberg, University Hospital Erlangen, Erlangen, Germany.
¹⁴ Translational Oncology/Early Clinical Trial Unit (ECTU), Comprehensive Cancer Center Mainfranken and Bavarian Cancer Research Center (BZKF), University Hospital Würzburg, Würzburg, Germany.
¹⁵ Department of Medicine II, Hematology/Oncology, University Hospital Frankfurt, Frankfurt, Germany.
¹⁶ Department of Pathology, University Hospital Giessen and Marburg, Giessen, Germany.
¹⁷ University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany.
¹⁸ Institute of Pathology, Heinrich-Heine-University and University Hospital Duesseldorf, Duesseldorf, Germany.
¹⁹ Department of Hematology and Stem Cell Transplantation, Faculty of Medicine and University Hospital Essen, University of Duisburg-Essen, Essen, Germany.
²⁰ Berlin Institute of Health at Charité Universitätsmedizin Berlin, Berlin, Germany.
²¹ Institute of Pathology, Faculty of Medicine and University Hospital Cologne, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Lung Cancer Group Cologne, University of Cologne, Cologne, Germany.

Abstract

Background: The national Network Genomic Medicine (nNGM) Lung Cancer provides comprehensive and high-quality multiplex molecular diagnostics and standardized personalized treatment recommendation for patients with advanced non-small cell lung cancer (aNSCLC) in Germany. The primary aim of this study was to investigate the effectiveness of the nNGM precision medicine program in terms of overall survival (OS) using real-world data (RWD).

Methods: A historical nationwide cohort analysis of patients with aNSCLC and initial diagnosis between 04/2019 and 06/2020 was conducted to compare treatment and OS of patients with and without nNGM-participation. Patients participating within the nNGM (nNGM group) were selected based on a prospective nNGM database. The electronic health records (EHR) of the prospective nNGM database were case-specifically linked to claims data (AOK, German health insurance). The control group was selected from claims data of patients receiving usual care without nNGM-participation (non-nNGM group). The minimum follow-up period was six months.

Findings: Overall, n = 509 patients in the nNGM group and n = 7213 patients in the non-nNGM group met the inclusion criteria. Patients participating in the nNGM had a significantly improved OS compared to the non-nNGM group (median OS: 10.5 months vs. 8.7 months, p = 0.008, HR = 0.84, 95% CI: 0.74-0.95). The 1-year survival rates were 46.8% (nNGM) and 41.3% (non-nNGM). The use of approved tyrosine kinase inhibitors (TKI) in the first-line setting was significantly higher in the nNGM group than in the non-nNGM group (nNGM: 8.4% (43/509) vs. non-nNGM: 5.1% (366/7213), p = 0.001). Overall, patients receiving first-line TKI treatment had significantly higher 1-year OS rates than patients treated with PD-1/PD-L1 inhibitors and/or chemotherapy (67.2% vs. 40.2%, p < 0.001).

Interpretation: This is the first study to demonstrate a significant survival benefit and higher utilization of targeted therapies for aNSCLC patients participating within nNGM. Our data indicate that precision medicine programs can enhance collaborative personalized lung cancer care and promote the implementation of treatment innovations and the latest scientific knowledge into clinical routine care.

Funding: The study was funded by the AOK Federal Association Germany.

Keywords: Non-small cell lung cancer; Personalized medicine; Precision medicine program; Real-world data; Targeted therapies.