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.

Autor:	Kästner A; Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Greifswald, Germany., Kron A; National Network Genomic Medicine Lung Cancer, Germany.; Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Lung Cancer Group Cologne, University Hospital of Cologne, Cologne, Germany., van den Berg N; Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Greifswald, Germany., Moon K; Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Greifswald, Germany., Scheffler M; National Network Genomic Medicine Lung Cancer, Germany.; Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Lung Cancer Group Cologne, University Hospital of Cologne, Cologne, Germany., Schillinger G; Federal Association of the AOK, Berlin, Germany., Pelusi N; National Network Genomic Medicine Lung Cancer, Germany.; Institute of Pathology, University Hospital Bonn, Bonn, Germany., Hartmann N; National Network Genomic Medicine Lung Cancer, Germany.; Institute of Pathology, University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany., Rieke DT; National Network Genomic Medicine Lung Cancer, Germany.; Charité Comprehensive Cancer Center, Charité Universitätsmedizin Berlin, Berlin, Germany., Stephan-Falkenau S; National Network Genomic Medicine Lung Cancer, Germany.; Institute of Pathology, Helios Klinikum Emil von Behring, Berlin, Germany., Schuler M; National Network Genomic Medicine Lung Cancer, Germany.; West German Cancer Center, University Hospital Essen, Essen, Germany., Wermke M; National Network Genomic Medicine Lung Cancer, Germany.; Clinic for Internal Medicine I, University Hospital Carl Gustav Carus and Medical Faculty of the TU Dresden, Dresden, Germany., Weichert W; National Network Genomic Medicine Lung Cancer, Germany.; Institute of Pathology, Technical University of Munich (TUM), Munich, Germany., Klauschen F; National Network Genomic Medicine Lung Cancer, Germany.; Institute of Pathology, Ludwig-Maximilians-University (LMU), Munich, Germany., Haller F; National Network Genomic Medicine Lung Cancer, Germany.; Institute of Pathology, Friedrich-Alexander University Erlangen-Nuremberg, University Hospital Erlangen, Erlangen, Germany., Hummel HD; National Network Genomic Medicine Lung Cancer, Germany.; Translational Oncology/Early Clinical Trial Unit (ECTU), Comprehensive Cancer Center Mainfranken and Bavarian Cancer Research Center (BZKF), University Hospital Würzburg, Würzburg, Germany., Sebastian M; National Network Genomic Medicine Lung Cancer, Germany.; Department of Medicine II, Hematology/Oncology, University Hospital Frankfurt, Frankfurt, Germany., Gattenlöhner S; National Network Genomic Medicine Lung Cancer, Germany.; Department of Pathology, University Hospital Giessen and Marburg, Giessen, Germany., Bokemeyer C; National Network Genomic Medicine Lung Cancer, Germany.; University Cancer Center Hamburg, University Medical Center Hamburg-Eppendorf, Hamburg, Germany., Esposito I; National Network Genomic Medicine Lung Cancer, Germany.; Institute of Pathology, Heinrich-Heine-University and University Hospital Duesseldorf, Duesseldorf, Germany., Jakobs F; National Network Genomic Medicine Lung Cancer, Germany.; Department of Hematology and Stem Cell Transplantation, Faculty of Medicine and University Hospital Essen, University of Duisburg-Essen, Essen, Germany., von Kalle C; National Network Genomic Medicine Lung Cancer, Germany.; Berlin Institute of Health at Charité Universitätsmedizin Berlin, Berlin, Germany., Büttner R; National Network Genomic Medicine Lung Cancer, Germany.; 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., Wolf J; National Network Genomic Medicine Lung Cancer, Germany.; Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf, Lung Cancer Group Cologne, University Hospital of Cologne, Cologne, Germany., Hoffmann W; Institute for Community Medicine, Section Epidemiology of Health Care and Community Health, University Medicine Greifswald, Greifswald, Germany.
Jazyk:	angličtina
Zdroj:	The Lancet regional health. Europe [Lancet Reg Health Eur] 2023 Nov 22; Vol. 36, pp. 100788. Date of Electronic Publication: 2023 Nov 22 (Print Publication: 2024).
DOI:	10.1016/j.lanepe.2023.100788
Abstrakt:	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. Competing Interests: AKä, nvdB, KM, and WH declare financial support from the Federal Association of the AOK, Berlin, Germany (e.g., for performing the analyses and writing the manuscript), as stated in the manuscript. MSche received institutional grants from Amgen, Bristol Myers Squibb, Dracen Pharmaceuticals Inc., Janssen, Novartis, Siemens Healthineers, personal consulting fees from Amgen, AstraZeneca, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Novartis, Pfizer, Roche, Sanofi-Aventis, Siemens Healthineers and Takeda, honoraria or payment for educational events from Amgen, AstraZeneca, Bristol Myers Squibb, Novartis, Pfizer, Sanofi-Aventis and Takeda; received support for attending meetings and/or travel from Boehringer Ingelheim, Janssen, Pfizer, AstraZeneca; and reports participation on a Data Safety Monitoring Board at Boehringer Ingelheim, a leadership or fiduciary role (unpaid) at the ESMO Lung Cancer Faculty, ESMO Climate Change Task Force and the EORTC Lung Cancer group. DTR received payment or honoraria from Roche (Bristol Myers Squibb), Bayer and Lilly for lectures, presentations, speakers’ bureaus, manuscript writing or educational events and support for attending meetings and/or travel from Bayer. MSchu received institutional grants from AstraZeneca and Bristol Myers Squibb, consulting fees from Amgen, AstraZeneca, Blueprint Medicines, Boehringer Ingelheim, Bristol Myers Squibb, GlaxoSmithKline, Janssen, Merck Serono, Novartis, Roche, Sanofi-Aventis and Takeda, payment or honoraria from Amgen, Boehringer Ingelheim, Bristol Myers Squibb, Janssen, Merck Sharp & Dohme, Novartis, Roche, Sanofi-Aventis for lectures, presentations, speakers’ bureaus, manuscript writing or educational events; received support for attending meetings and/or travel from Janssen, Bristol Myers Squibb, Roche, Boehringer Ingelheim, Novartis, Amgen; and participated in Data Safety Monitoring Boards or Advisory Boards at Amgen, Bristol-Myers Squibb, Novartis, Sanofi-Aventis, Janssen, Tacalyx, Abalos and GlaxoSmithKline. MW received institutional grants from Roche, personal consulting fees from Bristol Myers Squibb, Novartis, Lilly, Boehringer Ingelheim, Amgen, Immatics, Bayer and ImCheck Therapeutics, payment or honoraria for educational events from Lilly, Boehringer Ingelheim, SYNLAB, Janssen, Merck Serono, GWT-TUD GmbH, Amgen and Novartis; he received support for attending meetings and/or travel from Pfizer, Bristol Myers Squibb, AstraZeneca, Janssen, Amgen, GEMoaB, Sanofi-Aventis, Immatics, Merck Serono and Daiichi Sankyo and honoraria for participation in a Data Safety Monitoring Board or Advisory Board of ISA Pharmaceuticals. FK received payment or honoraria from Bristol-Myers Squibb, Merck Sharp & Dohme, Novartis, Roche, Lilly, Agilent, Bayer, Merck and Trillium for lectures, presentations, speakers’ bureaus, manuscript writing or educational events and is a board member at the National Pathologists’ Association Germany; and received personal honoraria for lectures by AstraZeneca and Novartis and participated in an advisory board by AstraZeneca. MSe received grants from AstraZeneca and consulting fees from AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Lilly, Roche, Boehringer Ingelheim, Amgen, Takeda, Johnson, Merck-Serono and GSK; received payment or honoraria from AstraZeneca, Bristol Myers Squibb, Merck Sharp & Dohme, Novartis, Lilly, Roche, Boehringer Ingelheim, Amgen, Takeda, Johnson, CureVac, BioNTech, Merck-Serono, GSK, Daiichi and Pfizer for lectures, presentations, speakers’ bureaus, manuscript writing or educational events; and received support for attending meetings and/or travel from Pfizer, Bristol-Myers Squibb and participated in a Data Safety Monitoring Board at Amgen. CB received consulting fees from the AOK NRW-Hamburg, and honoraria for participation in a Data Safety Monitoring Board or Advisory Board of AstraZeneca, Bayer Healthcare, Bristol Myers Squibb, Janssen-Cilag, Merck Serono and Sanofi-Aventis; received payment or honoraria for lectures given for Bristol Myers Squibb, Roche Pharma and Sanofi-Aventis; and received support for attending meetings and/or travel from Sanofi-Aventis, Janssen-Cilag and has an unpaid leadership or fiduciary role at DGHO, DKG-Zertifizierungskommission and CCC Netzwerk. RB received payment or honoraria for lectures and participation in advisory boards for AbbVie, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Boehringer Ingelheim, Illumina, Janssen, Lilly, Merck Serono, Merck Sharp & Dohme, Novartis, Qiagen, Pfizer, Roche and Targos MP Inc.; and reports a leadership or fiduciary role as co-founder and co-owner of Gnothis Inc (SE) and Timer Therapeutics Inc (GE). JW received funding from Amgen, AstraZeneca, Bayer, Blueprint, Bristol-Myers Squibb, Boehringer Ingelheim, Chugai, Daiichi Sankyo, Janssen, Lilly, Loxo, Merck, Mirati, Merck Sharp & Dohme, Novartis, Nuvalent, Pfizer, Pierre-Fabre, Roche, Seattle Genetics, Takeda and Turning Point. The remaining authors declare no conflict of interest. (© 2023 The Author(s).)
Databáze:	MEDLINE
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