Impact of poverty and neighborhood opportunity on outcomes for children treated with CD19-directed CAR T-cell therapy.
Haley M NewmanYimei LiHongyan LiuRegina M MyersVicky TamAmanda DiNofiaLisa WraySusan R RheingoldColleen CallahanClaire WhiteDiane BaniewiczLena E WinestoneStephan KadaukeCaroline DiorioCarl H JuneKelly GetzRichard AplencDavid Trent TeacheyShannon L MaudeStephan A GruppKira O BonaAllison Barz LeahyPublished in: Blood (2022)
Children living in poverty experience excess relapse and death from newly diagnosed acute lymphoblastic leukemia (ALL). The influence of household poverty and neighborhood social determinants on outcomes from CAR T-cell therapy for relapsed/refractory (r/r) leukemia is poorly described. We identified patients with r/r CD19+ ALL/lymphoblastic lymphoma treated on CD19-directed CAR T-cell clinical trials or with commercial tisagenlecleucel from 2012 to 2020. Socioeconomic status (SES) was proxied at the household-level, with poverty-exposure defined as Medicaid-only insurance. Low neighborhood opportunity was defined by the Childhood Opportunity Index. Among 206 patients aged 1-29, 35.9% were household-poverty exposed, and 24.9% had low neighborhood opportunity. Patients unexposed to household-poverty or low-opportunity neighborhoods were more likely to receive CAR T-cell therapy with high disease burden (>25%)-a disease characteristic associated with inferior outcomes-as compared to less advantaged patients (38% vs 30%; 37% vs 26%). Complete remission (CR) rate was 93% with no significant differences by household-poverty (P = 0.334) or neighborhood opportunity (P = 0.504). In multivariate analysis, patients from low-opportunity neighborhoods experienced increased hazard of relapse as compared to others (P = 0.006, adjusted HR 2.3, 95% CI 1.3-4.1). There was no difference in hazard of death (P = 0.545, adjusted HR 1.2, 95% CI 0.6-2.4). Among children who successfully receive CAR T-cell therapy, CR and OS is equitable regardless of proxied SES and neighborhood opportunity. Children from more advantaged households and neighborhoods receive CAR T-cell therapy with higher disease burden. Investigation of multicenter outcomes and access disparities outside of clinical-trial settings is warranted. Clinical trials: NCT01626495; NCT02435849 ; NCT02374333; NCT02228096; NCT02906371.
Keyphrases
- cell therapy
- newly diagnosed
- clinical trial
- end stage renal disease
- stem cells
- acute lymphoblastic leukemia
- mesenchymal stem cells
- physical activity
- chronic kidney disease
- ejection fraction
- young adults
- acute myeloid leukemia
- peritoneal dialysis
- prognostic factors
- type diabetes
- randomized controlled trial
- mental health
- phase ii
- open label
- diffuse large b cell lymphoma
- rheumatoid arthritis
- study protocol
- double blind
- affordable care act
- multiple myeloma
- ulcerative colitis
- bone marrow
- disease activity
- early life