Challenges for quality and utilization of real-world data for diffuse large B-cell lymphoma in REALYSA, a LYSA cohort
Year: 2023
Type: article
Abstract: ABSTRACT: Real-world data (RWD) are essential to complement clinical trial (CT) data, but major challenges remain, such as data quality. REal world dAta in LYmphoma and Survival in Adults (REALYSA) is a prospective noninterventional multicentric cohort started in 2018 that included patients newly diagnosed with lymphoma in France. Herein is a proof-of-concept analysis on patients with first-line diffuse large B-cell lymphoma (DLBCL) to (1) evaluate the capacity of the cohort to provide robust data through a multistep validation process; (2) assess the consistency of the results; and (3) conduct an exploratory transportability assessment of 2 recent phase 3 CTs (POLARIX and SENIOR). The analysis population comprised 645 patients with DLBCL included before 31 March 2021 who received immunochemotherapy and for whom 3589 queries were generated, resulting in high data completeness (<4% missing data). Median age was 66 years, with mostly advanced-stage disease and high international prognostic index (IPI) score. Treatments were mostly rituximab, cyclophosphamide, doxorubicin hydrochloride, vincristine, and prednisone (R-CHOP 75%) and reduced dose R-CHOP (13%). Estimated 1-year event-free survival (EFS) and overall survival rates were 77.9% and 90.0%, respectively (median follow-up, 9.9 months). Regarding transportability, when applying the CT's main inclusion criteria (age, performance status, and IPI), outcomes seemed comparable between patients in REALYSA and standard arms of POLARIX (1-year progression-free survival 79.8% vs 79.8%) and SENIOR (1-year EFS, 64.5% vs 60.0%). With its rigorous data validation process, REALYSA provides high-quality RWD, thus constituting a platform for numerous scientific purposes. The REALYSA study was registered at www.clinicaltrials.gov as #NCT03869619.
Source: Blood Advances
Authors: Hervé Ghesquières, Fanny Cherblanc, Aurélien Belot, Sophie Micon, Krimo K. Bouabdallah, Cyril Esnault, Luc-Matthieu Fornecker, Katia Thokagevistk, Maxime Bonjour, Fontanet Bijou, Corinne Haioun, Nadine Morineau, Loïc Ysebaert, Gandhi Damaj, Benoit Tessoulin, Stéphanie Guidez, Franck Morschhauser, Catherine Thiéblemont, Adrien Chauchet, Rémy Gressin, Fabrice Jardin, Christophe Fruchart, Gaëlle Labouré, Ludovic Fouillet, Pauline Lionne-Huyghe, Antoine Bonnet, Laure Lebras, Sandy Amorim, Cécile Leyronnas, Gaelle Olivier, Romain Guieze, Roch Houot, Vincent Launay, Bernard Drénou, Olivier Fitoussi, Laurence Detourmignies, Julie Abraham, Carole Soussain, Florence Lachenal, Gian Matteo Pica, Patrick Fogarty, Pascale Cony-Makhoul, Adeline Bernier, Sandra Le Guyader-Peyrou, Alain Monnereau, Frédéric Boissard, Cédric Rossi, Vincent Camus
Institutions: Lyon 1 Université, Hôpital Lyon Sud, The Lymphoma Academic Research Organisation, Roche (France), Centre Hospitalier Universitaire de Bordeaux, Institut de Cancérologie Strasbourg, Université de Strasbourg, Institut Bergonié, Assistance Publique – Hôpitaux de Paris, Hôpitaux Universitaires Henri-Mondor, Centre Hospitalier Départemental Vendée, Institut universitaire du cancer de Toulouse Oncopole, Centre Hospitalier Universitaire de Caen Normandie, Centre Hospitalier Universitaire de Nantes, Centre Hospitalier Universitaire de Poitiers, Université de Lille, Centre Hospitalier Universitaire de Lille, Groupe de Recherche sur les formes Injectables et les Technologies Associées, Université Paris Cité, Hôpital Saint-Louis, Centre Hospitalier Universitaire de Besançon, Centre National de la Recherche Scientifique, Inserm, Centre Hospitalier Universitaire de Grenoble, Institut pour l'avancée des biosciences, Université Grenoble Alpes, Centre Henri Becquerel, Centre Hospitalier Universitaire de Saint-Étienne, Centre Hospitalier d'Arras, Centre hospitalier Bretagne Atlantique, Centre Léon Bérard, Groupe Hospitalier Mutualiste de Grenoble, Centre Hospitalier de Niort, Centre Hospitalier Universitaire de Clermont-Ferrand, Centre Hospitalier Universitaire de Rennes, Centre Hospitalier de Saint-Brieuc, Groupe Hospitalier de la Région de Mulhouse et Sud Alsace, Polyclinique Bordeaux Nord Aquitaine, Centre Hospitalier de Roubaix, Centre Hospitalier Universitaire de Limoges, Institut Curie, Centre Hospitalier Métropole Savoie, Université de Bordeaux, F. Hoffmann-La Roche AG, CHU Dijon Bourgogne
Language: English
Subfield: Pathology and Forensic Medicine
Field: Medicine
Domain: Health Sciences
Open Access status: gold
Estimated APC paid: $3,000
OpenAlex ID: W4387900904