Dataset Information

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

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.

SUBMITTER: Ghesquieres H

PROVIDER: S-EPMC10824688 | biostudies-literature | 2024 Jan

REPOSITORIES: biostudies-literature

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

Ghesquières Hervé H Cherblanc Fanny F Belot Aurélien A Micon Sophie S Bouabdallah Krimo K KK Esnault Cyril C Fornecker Luc-Matthieu LM Thokagevistk Katia K Bonjour Maxime M Bijou Fontanet F Haioun Corinne C Morineau Nadine N Ysebaert Loïc L Damaj Gandhi G Tessoulin Benoit B Guidez Stéphanie S Morschhauser Franck F Thiéblemont Catherine C Chauchet Adrien A Gressin Rémy R Jardin Fabrice F Fruchart Christophe C Labouré Gaëlle G Fouillet Ludovic L Lionne-Huyghe Pauline P Bonnet Antoine A Lebras Laure L Amorim Sandy S Leyronnas Cécile C Olivier Gaelle G Guieze Romain R Houot Roch R Launay Vincent V Drénou Bernard B Fitoussi Olivier O Detourmignies Laurence L Abraham Julie J Soussain Carole C Lachenal Florence F Pica Gian Matteo GM Fogarty Patrick P Cony-Makhoul Pascale P Bernier Adeline A Le Guyader-Peyrou Sandra S Monnereau Alain A Boissard Frédéric F Rossi Cédric C Camus Vincent V

Blood advances 20240101 2

<h4>Abstract</h4>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 ro ...[more]

PMID: 37874913

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Project description:BackgroundDiffuse large B-cell lymphoma (DLBCL) patients refractory to rituximab-based immunochemotherapy have a dismal prognosis. However, the definition of refractory DLBCL remains inconsistent and no large cohort study data is available from Asian countries. To validate the definition and outcomes of refractory DLBCL in China, we conducted a multicenter, retrospective cohort study.MethodsThe REtrospective AnaLysis of Treatment REspoNse of refractory DLBCL (REAL-TREND) study was performed using real-world data from 8 centers in China. DLBCL patients with curative intent were included in the REAL-TREND dataset. Overall survival (OS) was estimated using the Kaplan-Meier method and compared by the log-rank test. Due to heterogeneity in response rates among different centers, the response rates of refractory patients were pooled using random-effect models. Multivariate survival analysis was performed using the Cox regression model.ResultsA total of 2778 DLBCL patients diagnosed between January, 2010 and December, 2015 were enrolled to this study. After validating previous definitions, the SCHOLAR-1 study was most suitable to define refractory DLBCL. The estimated 5-year cumulative incidence of refractory patients was 20% (95% confidence Interval [CI] = 18%-22%). After the determination of refractory disease, overall response rate and complete remission rate were 30% (95% CI = 22%-38%) and 9% (95% CI = 4%-15%), respectively. Patients with either no response to immunochemotherapy or relapse within 12 months after stem-cell transplantation had inferior survival with a median OS of 5.9 months (95% CI = 5.5-7.1 months) and 2-year OS rate of 16% (95% CI = 12%-20%). International prognostic index score 4-5 (hazard ratio [HR] = 2.22; 95% CI = 1.47-3.35), central nervous system relapse (HR = 1.43; 95% CI = 1.04-1.97), and best response status (HR = 2.68; 95% CI = 1.42-5.03 for partial remission. HR = 5.97, 95% CI = 3.21-11.11 for stable disease/progressive disease) were independent unfavorable prognostic factors.ConclusionsThis is the first large-scale Asian cohort study focusing on outcomes of refractory DLBCL. The definition of the SCHOLAR-1 study identifies patients with homogenously inferior survival, thus is appropriate to select refractory DLBCL. Due to poor clinical outcomes in the rituximab era, patients with refractory DLBCL may be potential candidates for novel treatment modalities.

Project description:PurposeTafasitamab, an Fc-modified, humanized, anti-CD19 monoclonal antibody, in combination with lenalidomide, demonstrated efficacy in transplant-ineligible patients with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL), in the single-arm, phase II L-MIND study (NCT02399085). RE-MIND, a retrospective observational study, generated a historic control for L-MIND to delineate the contribution of tafasitamab to the efficacy of the combination.Patients and methodsData were retrospectively collected from patients with R/R DLBCL treated with lenalidomide monotherapy for comparison with tafasitamab + lenalidomide-treated patients (L-MIND). Key eligibility criteria were aligned with L-MIND. Estimated propensity score-based Nearest Neighbor 1:1 Matching methodology balanced the cohorts for nine prespecified prognostic baseline covariates. The primary endpoint was investigator-assessed best overall response rate (ORR). Secondary endpoints included complete response (CR) rate, progression-free survival (PFS), and overall survival (OS).ResultsData from 490 patients going through lenalidomide monotherapy were collected; 140 qualified for matching with the L-MIND cohort. The primary analysis included 76 patients from each cohort who received a lenalidomide starting dose of 25 mg/day. Cohort baseline covariates were comparable. A significantly better ORR of 67.1% (95% confidence interval, 55.4-77.5) was observed for the combination therapy versus 34.2% (23.7-46.0) for lenalidomide monotherapy [odds ratio, 3.89 (1.90-8.14); P < 0.0001]. Higher CR rates were achieved with combination therapy compared with lenalidomide monotherapy [39.5% (28.4-51.4) vs. 13.2% (6.5-22.9)]. Survival endpoints favored combination therapy. Lenalidomide monotherapy outcomes were similar to previously published data.ConclusionsRE-MIND enabled the estimation of the additional treatment effect achieved by combining tafasitamab with lenalidomide in patients with R/R DLBCL.

Dataset Information

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

Abstract

Publications

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

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