Challenges for quality and utilization of ...
Document type :
Article dans une revue scientifique: Article original
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Permalink :
Title :
Challenges for quality and utilization of real-world data for diffuse large B-cell lymphoma in REALYSA, a LYSA cohort.
Author(s) :
Ghesquieres, H. [Auteur]
Cherblanc, F. [Auteur]
Belot, A. [Auteur]
Micon, S. [Auteur]
Bouabdallah, K. [Auteur]
Esnault, C. [Auteur]
Fornecker, L. M. [Auteur]
Thokagevistk, K. [Auteur]
Bonjour, M. [Auteur]
Bijou, F. [Auteur]
Haioun, C. [Auteur]
Morineau, N. [Auteur]
Ysebaert, L. [Auteur]
Damaj, G. [Auteur]
Tessoulin, B. [Auteur]
Guidez, S. [Auteur]
Morschhauser, Franck [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Thieblemont, C. [Auteur]
Chauchet, A. [Auteur]
Gressin, R. [Auteur]
Jardin, F. [Auteur]
Fruchart, C. [Auteur]
Labouré, G. [Auteur]
Fouillet, L. [Auteur]
Lionne-Huyghe, P. [Auteur]
Bonnet, A. [Auteur]
Lebras, L. [Auteur]
Amorim, S. [Auteur]
Leyronnas, C. [Auteur]
Olivier, G. [Auteur]
Guieze, R. [Auteur]
Houot, R. [Auteur]
Launay, V. [Auteur]
Drénou, B. [Auteur]
Fitoussi, O. [Auteur]
Detourmignies, L. [Auteur]
Abraham, J. [Auteur]
Soussain, C. [Auteur]
Lachenal, F. [Auteur]
Pica, G. M. [Auteur]
Fogarty, P. [Auteur]
Cony-Makhoul, P. [Auteur]
Bernier, A. [Auteur]
Le Guyader-Peyrou, S. [Auteur]
Monnereau, A. [Auteur]
Boissard, F. [Auteur]
Rossi, C. [Auteur]
Camus, V. [Auteur]
Cherblanc, F. [Auteur]
Belot, A. [Auteur]
Micon, S. [Auteur]
Bouabdallah, K. [Auteur]
Esnault, C. [Auteur]
Fornecker, L. M. [Auteur]
Thokagevistk, K. [Auteur]
Bonjour, M. [Auteur]
Bijou, F. [Auteur]
Haioun, C. [Auteur]
Morineau, N. [Auteur]
Ysebaert, L. [Auteur]
Damaj, G. [Auteur]
Tessoulin, B. [Auteur]
Guidez, S. [Auteur]
Morschhauser, Franck [Auteur]

Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Thieblemont, C. [Auteur]
Chauchet, A. [Auteur]
Gressin, R. [Auteur]
Jardin, F. [Auteur]
Fruchart, C. [Auteur]
Labouré, G. [Auteur]
Fouillet, L. [Auteur]
Lionne-Huyghe, P. [Auteur]
Bonnet, A. [Auteur]
Lebras, L. [Auteur]
Amorim, S. [Auteur]
Leyronnas, C. [Auteur]
Olivier, G. [Auteur]
Guieze, R. [Auteur]
Houot, R. [Auteur]
Launay, V. [Auteur]
Drénou, B. [Auteur]
Fitoussi, O. [Auteur]
Detourmignies, L. [Auteur]
Abraham, J. [Auteur]
Soussain, C. [Auteur]
Lachenal, F. [Auteur]
Pica, G. M. [Auteur]
Fogarty, P. [Auteur]
Cony-Makhoul, P. [Auteur]
Bernier, A. [Auteur]
Le Guyader-Peyrou, S. [Auteur]
Monnereau, A. [Auteur]
Boissard, F. [Auteur]
Rossi, C. [Auteur]
Camus, V. [Auteur]
Journal title :
Blood Advances
Abbreviated title :
Blood Adv
Volume number :
8
Pages :
296–308
Publication date :
2024-01-23
ISSN :
2473-9537
HAL domain(s) :
Sciences du Vivant [q-bio]
English abstract : [en]
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 ...
Show more >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.Show less >
Show more >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.Show less >
Audience :
Internationale
Popular science :
Non
Administrative institution(s) :
Université de Lille
CHU Lille
CHU Lille
Collections :
Submission date :
2023-12-04T12:21:58Z
2024-06-10T14:32:09Z
2024-06-10T14:32:09Z