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

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.