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Challenges for quality and utilization of real-world data for diffuse large B-cell lymphoma in REALYSA, a LYSA cohort

dc.rights.licenseopenen_US
dc.contributor.authorGHESQUIERES, Herve
dc.contributor.authorCHERBLANC, Fanny
dc.contributor.authorBELOT, Aurelien
dc.contributor.authorMICON, Sophie
dc.contributor.authorBOUABDALLAH, Krimo
dc.contributor.authorESNAULT, Cyril
dc.contributor.authorFORNECKER, Luc-Matthieu
dc.contributor.authorTHOKAGEVISTK, Katia
dc.contributor.authorBONJOUR, Maxime
dc.contributor.authorBIJOU, Fontanet
dc.contributor.authorHAIOUN, Corinne
dc.contributor.authorMORINEAU, Nadine
dc.contributor.authorYSEBAERT, Loic
dc.contributor.authorDAMAJ, Gandhi
dc.contributor.authorTESSOULIN, Benoit
dc.contributor.authorGUIDEZ, Stephanie
dc.contributor.authorMORSCHHAUSER, Franck
dc.contributor.authorTHIEBLEMONT, Catherine
dc.contributor.authorCHAUCHET, Adrien
dc.contributor.authorGRESSIN, Remy
dc.contributor.authorJARDIN, Fabrice
dc.contributor.authorFRUCHART, Christophe
dc.contributor.authorLABOURE, Gaelle
dc.contributor.authorFOUILLET, Ludovic
dc.contributor.authorLIONNE-HUYGHE, Pauline
dc.contributor.authorBONNET, Antoine
dc.contributor.authorLEBRAS, Laure
dc.contributor.authorAMORIM, Sandy
dc.contributor.authorLEYRONNAS, Cecile
dc.contributor.authorOLIVIER, Gaelle
dc.contributor.authorGUIEZE, Romain
dc.contributor.authorHOUOT, Roch
dc.contributor.authorLAUNAY, Vincent
dc.contributor.authorDRENOU, Bernard
dc.contributor.authorFITOUSSI, Olivier
dc.contributor.authorDETOURMIGNIES, Laurence
dc.contributor.authorABRAHAM, Julie
dc.contributor.authorSOUSSAIN, Carole
dc.contributor.authorLACHENAL, Florence
dc.contributor.authorPICA, Gian Matteo
dc.contributor.authorFOGARTY, Patrick
dc.contributor.authorCONY-MAKHOUL, Pascale
dc.contributor.authorBERNIER, Adeline
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorLE GUYADER-PEYROU, Sandra
hal.structure.identifierBordeaux population health [BPH]
dc.contributor.authorMONNEREAU, Alain
dc.contributor.authorBOISSARD, Frederic
dc.contributor.authorROSSI, Cedric
dc.contributor.authorCAMUS, Vincent
dc.date.accessioned2023-12-07T14:15:25Z
dc.date.available2023-12-07T14:15:25Z
dc.date.issued2023-10-24
dc.identifier.issn2473-9537en_US
dc.identifier.urihttps://oskar-bordeaux.fr/handle/20.500.12278/186443
dc.description.abstractEnReal-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.
dc.language.isoENen_US
dc.subject.enDiffuse large B-cell lymphoma
dc.subject.enReal-world cohort data
dc.subject.enREALYSA
dc.subject.enData quality
dc.subject.en75 clinical trial transportability
dc.title.enChallenges for quality and utilization of real-world data for diffuse large B-cell lymphoma in REALYSA, a LYSA cohort
dc.title.alternativeBlood Adven_US
dc.typeArticle de revueen_US
dc.identifier.doi10.1182/bloodadvances.2023010798en_US
dc.subject.halSciences du Vivant [q-bio]/Santé publique et épidémiologieen_US
dc.identifier.pubmed37874913en_US
bordeaux.journalBlood Advancesen_US
bordeaux.hal.laboratoriesBordeaux Population Health Research Center (BPH) - UMR 1219en_US
bordeaux.institutionUniversité de Bordeauxen_US
bordeaux.institutionINSERMen_US
bordeaux.teamEPICENE_BPHen_US
bordeaux.peerReviewedouien_US
bordeaux.inpressnonen_US
bordeaux.identifier.funderIDHospices Civils de Lyonen_US
bordeaux.identifier.funderIDRocheen_US
bordeaux.identifier.funderIDTakeda Oncologyen_US
bordeaux.identifier.funderIDJanssen Pharmaceuticalsen_US
bordeaux.identifier.funderIDAmgenen_US
bordeaux.identifier.funderIDCelgeneen_US
bordeaux.identifier.funderIDF. Hoffmann-La Rocheen_US
hal.identifierhal-04329432
hal.version1
hal.date.transferred2023-12-07T14:15:30Z
hal.popularnonen_US
hal.audienceInternationaleen_US
hal.exporttrue
dc.rights.ccPas de Licence CCen_US
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