Challenges for quality and utilization of real-world data for diffuse large B-cell lymphoma in REALYSA, a LYSA cohort.
Fiche publication
Date publication
octobre 2023
Journal
Blood advances
Auteurs
Membres identifiés du Cancéropôle Est :
Pr FORNECKER Luc-Matthieu, Dr DRENOU Bernard, Dr ROSSI Cédric
Tous les auteurs :
Ghesquieres H, Cherblanc F, Belot A, Micon S, Bouabdallah K, Esnault C, Fornecker LM, Thokagevistk K, Bonjour M, Bijou F, Haioun C, Morineau N, Ysebaert L, Damaj G, Tessoulin B, Guidez S, Morschhauser F, Thieblemont C, Chauchet A, Gressin R, Jardin F, Fruchart C, Labouré G, Fouillet L, Lionne-Huyghe P, Bonnet A, Lebras L, Amorim S, Leyronnas C, Olivier G, Guieze R, Houot R, Launay V, Drénou B, Fitoussi O, Detourmignies L, Abraham J, Soussain C, Lachenal F, Pica GM, Fogarty P, Cony-Makhoul P, Bernier A, Le Guyader-Peyrou S, Monnereau A, Boissard F, Rossi C, Camus V
Lien Pubmed
Résumé
Real-world data are essential to complement clinical trial (CT) data, but major challenges remain, like data quality. REal world dAta in LYmphoma and Survival in Adults (REALYSA) is a prospective non-interventional multicentric cohort started in 2018 (NCT03869619) including patients newly diagnosed with lymphoma in France. Herein is a proof-of-concept analysis on first-line DLBCL patients to (i) evaluate the capacity of the cohort to provide robust data through a multi-step validation process; (ii) assess the consistency of the results; (iii) conduct an exploratory transportability assessment of two recent phase 3 CT (POLARIX, SENIOR). The analysis population comprised DLBCL patients included before March 31st 2021, who received immunochemotherapy. 645 patients were included, for whom 3589 queries were generated, resulting in high data completeness (<4% missing data). Median age was 66 years (19-98) with mostly advanced-stage disease (472; 73%) and high international prognostic index (IPI) score (IPI 2-5, 486; 76%). Treatments were mostly R-CHOP (482; 75%) and R-miniCHOP (86; 13%). Estimated 1-year EFS and OS were 77.9% (95% CI: 73.8-81.4) and 90.0% (95% CI: 86.5-92.5), respectively (median follow-up: 9.9 months). Regarding transportability, when applying trials' main inclusion criteria (age, PS, IPI), outcomes seemed comparable between REALYSA patients and standard arms of POLARIX (1-year PFS 79.8% (95% CI, 75.9-83.6) vs. 79.8% (95% CI, 73.9-84.4)) and SENIOR (1-year EFS à 64.5% (95% CI: 47.8-77.0) vs. 60.0% (95% CI: 50.8-68.1)). With its rigorous data validation process, REALYSA program provides high-quality RWD, thus constituting a platform for numerous scientific purposes.
Référence
Blood Adv. 2023 10 24;: