Actionable NSCLC Mutation Identification by Comprehensive Genomic Profiling for Clinical Trial Enrollment: The European Program for the Routine Testing of Patients With Advanced Lung Cancer (EPROPA)
- PMID: 39694416
- DOI: 10.1016/j.jtho.2024.12.010
Actionable NSCLC Mutation Identification by Comprehensive Genomic Profiling for Clinical Trial Enrollment: The European Program for the Routine Testing of Patients With Advanced Lung Cancer (EPROPA)
Abstract
Introduction: The advocacy Women Against Lung Cancer in Europe (WALCE) promoted the European Program for the Routine Testing of Patients With Advanced Lung Cancer (EPROPA) and provided a free-of-charge molecular profiling platform for NSCLC sample characterization with the aim of increasing the detection of targetable drivers and improving patients' access to clinical trials in Europe.
Methods: From January 2021 to December 2023, 20 centers located at five different European countries (Greece, Slovenia, Romania, Albania, and Italy) joined EPROPA, with 555 patients with advanced NSCLC registered to the program. Anonymized patients' clinical-pathological data were shared through the EPROPA web platform and tissue samples were collected at the Molecular Pathology Unit of the Reference Center (University of Turin) for molecular analyses. A comprehensive genomic profiling by a targeted next-generation sequencing approach has been performed and molecular reports have been discussed within the molecular tumor board to assess patients' eligibility for clinical trials.
Results: The average turnaround time was eight days, with only 30 out of 555 tissue samples (6%) not suitable for molecular analysis. In the 525 analyzed samples, a total of 570 molecular alterations have been identified, including 264 pathogenic targetable oncogenic alterations and 113 cases with co-occurring mutations. A total of 18 molecular alterations with potential germline and hereditary cancer syndrome implications have been reported. The identification of a clinical trial was considered for 205 patients. After molecular tumor board discussion, 30 patients were enrolled and treated in clinical studies available in Europe. Survival outcomes were significantly improved in patients with targetable molecular alterations receiving a matched targeted therapy.
Conclusion: This data confirmed the feasibility and usefulness of the program in the real-world practice scenario, supporting the implementation of next-generation sequencing-based molecular characterization of NSCLC samples, to reduce the unequal access to tests, drugs, and clinical trials in Europe.
Keywords: Advocacy; Biomarker testing; Clinical trials; Lung cancer; Precision medicine; Targeted therapy.
Copyright © 2024 International Association for the Study of Lung Cancer. Published by Elsevier Inc. All rights reserved.
Conflict of interest statement
Disclosure Dr. Passiglia received consultants’ and advisory fees from AstraZeneca, BMS, Novartis, Pfizer, Roche, MSD, Amgen, Johnson and Johnson, Sanofi, Beigene, Gilead, Regeneron, Pharmamar, Thermo Fisher Scientific. Dr. Bironzo reports personal fees (as advisor) from Seagen, Regeneron, Pierre Fabre, and Janssen and research grants (Institution) from Pfizer and Roche. Dr. Tabbò reports personal fees (as speaker bureau) from AstraZeneca, Novartis, Roche, and Takeda. Dr. Buffoni reports personal fees (as advisor) from AstraZeneca, BMS, MSD, Novartis. Dr. Mazilu reports personal fees (as speaker bureau, advisor, manuscript writer, or travel expenses) from Accord, Angelini, Astellas, AstraZeneca, Bayer, BMS, Eli Lilly, Ipsen, Johnson & Johnson Romania, Merck, MSD, Novartis, Pfizer, Roche, Sandoz, Sanofi. Dr. Pignataro reports personal fees (as speaker bureau) from AstraZeneca, BMS, Novartis, Roche, and Takeda. Dr. Araujo reports personal fees (as speaker bureau, advisor, manuscript writer, or travel expenses) from Astellas, AstraZeneca, BMS, Eli Lilly Oncology, Janssen, MSD, Novartis, Pfizer, Roche. Dr. Paz-Ares reports personal fees (honoraria or travel expenses) from Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol-Myers Squibb, Celgene, Incyte, Ipsen, Lilly, Merck Serono, Mirati, MSD, Novartis, PharmaMar, Pfizer, Roche/Genentech, Sysmex. Other relationships (immediate family member) with Amgen, Ipsen, Merck, Novartis, Pfizer, Roche, Sanofi, and Servier. Cofounder of Altum Sequencing and an external board member for Genomica. Dr. Felip reports personal fees (as speaker bureau, advisor, or travel expenses) from AbbVie, Amgen, AstraZeneca, Bayer, BeiGene, BMS, Boeringher Ingelheim, Daichii Sankyo, Eli Lilly, F. Hoffmann-La Roche, Genentech, Gilead, GlaxoSmithKline, Janssen, Medical Trends, Medscape, Merck Serono, Merck Sharp & Dohme, Novartis, Peervoice, Peptomyc, Pfizer, Regeneron, Roche, Sanofi, Takeda, Touch Oncology, Turning Point. Ms. Comanescu reports personal fees (as advisor) from Novartis A.C.B. reports personal fees (as advisor or support for attending meetings) from BMS, Sanofi, and Takeda. Dr. Scotti reports personal fees (as speaker bureau or advisor) from AstraZeneca, BMS, MSD, Roche, Novatis, and Takeda. Research grant from AstraZeneca. Dr. Linardou reports personal fees (as advisor) from Amgen, AstraZeneca, BMS, GSK, MSD, Novartis, Pfizer, and Roche. Dr. Mohorcic reports personal fees (as advisor or support for attending meetings) from Amgen, BMS, Boehringer Ingelheim, Elli Lilly, Janssen, MSD, Pfizer, Roche, and Takeda. Dr. Malapelle reports personal fees (as speaker bureau or advisor) from Amgen Inc., AstraZeneca, Boehringer Ingelheim, Diatech, Eli Lilly & Company, GlaxoSmithKline, Hedera, Janssen Biotech, Merck Sharpe & Dohme Corporation, Novartis, Qiagen, Roche Health Solutions Inc., Thermo Fisher Scientific. Leadership Role: International Society of Liquid Biopsy and The Journal of Liquid Biopsy - Elsevier Spouse Dependent: Roche. Dr. Righi received consultants’ fees from AstraZeneca, Novartis, Roche, Amgen, BeiGene, Novartis, and Eli Lilly. Dr. Scagliotti reports personal fees (as consultant/advisor) from AstraZeneca, Bayer, BeiGene, Eli Lilly, J&J, MSD, Pfizer, Roche, and Takeda. Dr. Novello reports personal fees (as speaker bureau or advisor) from Eli Lilly, MSD, Roche, Takeda, Pfizer, Astra Zeneca, Amgen, Thermo Fisher, Novartis, Sanofi, Janssen, unrelated to the current work. The remaining authors declare no conflict of interest.
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