Retrospective analysis of real-world data to evaluate actionability of a comprehensive molecular profiling panel in solid tumor tissue samples (REALM study).

Autor: Leroy K; Université Paris Cité, Sorbonne Université, Inserm, Centre de Recherche des Cordeliers, Paris, France.; Département de Médecine Génomique des Tumeurs et Cancers, Service de Biochimie, AP-HP, Hôpital Européen Georges Pompidou, Paris, France., Audigier Valette C; Pôle Médecine à Orientation Oncologique, Hôpital Sainte Musse, Toulon, France., Alexandre J; Université Paris Cité, Sorbonne Université, Inserm, Centre de Recherche des Cordeliers, Paris, France.; Service d'Oncologie, AP-HP, Hôpital Cochin, Paris, France., Boussemart L; Service de Dermatologie, CHU de Nantes-Hôtel Dieu, Nantes, France., Chiesa J; UF de Cytogénétique et Génétique Médicale, Hôpital Universitaire Carémeau, Nîmes, France., Deldycke C; Pôle Régional de Cancérologie-CHU de Poitiers, Poitiers, France., Gomez-Rocca C; Oncologie Médicale, IUCT Oncopole, Toulouse, France., Hollebecque A; DITEP, Gustave Roussy, Villejuif, France., Lehmann-Che J; Université Paris Cité, INSERM U976, Immunologie Humaine, Pathophysiologie, Immunothérapie (HIPI), Paris, France.; UF Oncologie Moléculaire, Hôpital Saint-Louis, AP-HP, Paris, France., Lemoine A; Biochimie et Oncogénétique-Inserm UMRS 1193, Hôpital Paul Brousse, AP-HP, Paris, France., Mansard S; Service de Dermatologie, CHU-Estaing, Clermont-Ferrand, France., Medioni J; Centre d'Essais Précoces en Cancérologie, Hôpital Européen Georges Pompidou, Paris, France., Monnet I; Service de Pneumologie, Hôpital Intercommunal de Créteil, Créteil, France., Mourah S; Université Paris Cité, INSERM U976, Immunologie Humaine, Pathophysiologie, Immunothérapie (HIPI), Paris, France.; Service de Génomique des Tumeurs et Pharmacologie, Hôpital Saint-Louis, AP-HP, Paris, France., Pierret T; Onco-Pneumologie, Hospices Civils de Lyon, Lyon, France., Spaëth D; Centre d'Oncologie de Gentilly, Institut Interrégional de Cancérologie, Nancy, France., Civet A; Centre de Données Médicales, Roche S.A.S, Boulogne-Billancourt, France., Galoin S; Affaires Médicales, Roche S.A.S, Boulogne-Billancourt, France., Italiano A; Unité d'études de Phases Précoces, Institut Bergonié, Bordeaux, France.
Jazyk: angličtina
Zdroj: PloS one [PLoS One] 2023 Sep 14; Vol. 18 (9), pp. e0291495. Date of Electronic Publication: 2023 Sep 14 (Print Publication: 2023).
DOI: 10.1371/journal.pone.0291495
Abstrakt: Introduction: Considering the growing interest in matched cancer treatment, our aim was to evaluate the ability of a comprehensive genomic profiling (CGP) assay to propose at least one targeted therapy given an identified genomic alteration or signature (actionability), and to collect the treatment modifications based on the CGP test results in clinical practise for solid tumors.
Methods: This retrospective, multicentre French study was conducted among 25 centres that participated in a free of charge program between 2017 and 2019 for a tissue CGP test. Data were collected on the patient, disease, tumor genomic profile, treatment suggested in the report (related to the genomic profile results) and subsequent therapeutic decisions according to the physician's declaration.
Results: Among the 416 patients, most had lung cancer (35.6%), followed by biliary tract cancer (11.5%) or rare cancers (11.1%); 75% had a metastatic disease. The actionability was 75.0% (95% CI [70.6%-78.9%]) for all patients, 85.1% and 78.4%, respectively in lung cancer and metastatic patients. After exclusion of clinical trial suggestions, the actionability decreased to 62.3% (95% CI [57.5%-66.8%]). Treatment modification based on the test results was observed in 17.3% of the patients and was more frequent in metastatic disease (OR = 2.73, 95% CI [1.31-5.71], p = 0.007). The main reasons for no treatment modification were poor general condition (33.2%) and stable disease or remission (30.2%). The genomic-directed treatment changes were performed mostly during the first six months after the CGP test, and interestingly a substantial part was observed from six to 24 months after the genomic profiling.
Conclusion: This French study provides information on the real-life actionability of a CGP test based on tissue samples, and trends to confirm its utility in clinical practice across the course of the disease, in particularly for patients with lung cancer and/or advanced disease.
Competing Interests: “I have read the journal’s policy and the authors of this manuscript have the following competing interests: Karen Leroy: Roche- board, conference fees, scientific collaboration, scientific meeting fees; AstraZeneca, BMS- board, conference fees, scientific meeting fees; Lilly, Janssen- board; Amgen, MSD, GSK- scientific meeting fees; Nanostring- conference fees, scientific collaboration. Clarisse Audigier Valette: AstraZeneca, Boehringer Ingelheim- Financial Interests, Personal, Principal Investigator, Advisory Role; BMS, Lilly, Novartis, Pfizer-Financial Interests, Personal, Invited Speaker, Advisory Role; Abb Vie, GlaxoSmithKline, Janssen, MSD, Roche, Sanofi, Takeda-Financial Interests, Personal, Advisory Role. Antoine Italiano: Roche- Financial Interests, Personal, Advisory Board, Research Grant Roche. This does not alter our adherence to PLOS ONE policies on sharing data and materials.”
(Copyright: © 2023 Leroy et al. This is an open access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited.)
Databáze: MEDLINE
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