Availability and completeness of real-world data in United States community oncology/hematology practices regarding chimeric antigen receptor (CAR T)-cell therapy for relapsed/refractory diffuse large B-cell lymphoma

Abstract

This retrospective, observational study evaluated real-world data (RWD) completeness for 65 adults with relapsed/refractory (R/R) diffuse large B-cell lymphoma (DLBCL) treated with chimeric antigen receptor (CAR) T-cell therapy across 11 community practices in 2019. Eligible patients had ≥ 6 months of follow-up, excluding those who died earlier, had CNS metastases, or participated in clinical trials. Physicians abstracted electronic medical records (EMRs) in 2021 using standardized case report forms (eCRFs), capturing demographics, prior therapies, referral/infusion timelines, toxicities, hospitalizations, and survival. Data underwent quality validation. Baseline demographics were fully documented: 70.8 % of patients had good performance status (Eastern Cooperative Oncology Group [ECOG] 0–1), 73.8 % had elevated lactate dehydrogenase (LDH), and 83.9 % were deemed high-risk. Hospitalization and emergency visit records were 100 % complete, whereas toxicity documentation ranged from 86.2 % to 98.5 %. Patients received a median 3 prior therapy lines; key barriers to CAR T-cell therapy referral included patient choice (45.5 %), center location (36.4 %), and logistics (27.3 %). Rapid disease progression precluded treatment in 81.8 % of nonrecipients. Only 43.1 % had leukapheresis dates recorded, with a 4.5-month median from relapse to infusion. Posttreatment, 75.0 % developed cytokine release syndrome (CRS) and 67.7 % had fever. At median 15.5-month follow-up, 44.6 % relapsed and 47.7 % died. Survival (median progression-free survival, 18.6 months; overall survival, 22.8 months) aligned with trials but revealed disparities in real-world delivery, such as manufacturing delays and incomplete documentation. This study underscores feasibility of robust RWD collection in community settings while highlighting critical gaps—particularly in leukapheresis tracking and postinfusion toxicity reporting—that must be addressed to optimize CAR T-cell therapy management.