Pediatric patients and young adults with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) who are Hispanic, predominantly Spanish-speaking, or publicly insured appear to be underrepresented when referred from outside hospitals to B-cell centers. CAR T cells than those treated at consortium sites and enrolled in a CAR T clinical trial, according to findings from a cohort study published in Transplantation and Cell Therapy.
In a population of 337 B-ALL patients, 112 were referred from an outside hospital to a consortium site and enrolled in a CAR T-cell therapy study. In addition, 225 patients were treated primarily at one consortium site, 34% of whom were enrolled in a CAR T study. Those treated at one consortium site were found to have comparable characteristics.
The researchers reported that fewer Hispanic patients (37% vs. 56%; p = .03), those who mainly spoke Spanish (8% vs 22%; p = .006), and those with public insurance (38% vs 65%; p = 0.001) were referred from outside hospitals versus those treated primarily at consortium sites and enrolled in a CAR T-cell therapy clinical trial.
The researchers conducted the multicenter retrospective cohort trial through the Consortium for Pediatric Cellular Immunotherapy (CPCI), which was designed to accelerate access to pediatric immunotherapy studies for life-threatening disorders.
The study included relapsed/refractory B-ALL patients aged 0–27 years who received treatment at a consortium site from 2012 to 2018. Patients were divided based on whether they were primarily treated at a CPCI site or were referred from an outside hospital to a CPCI site before enrollment in a CAR T-cell trial.
Of patients enrolled in the trial, 44% were Hispanic, 36% were non-Hispanic white, 2% were non-Hispanic black, 5% were non-Hispanic Asian, 10% were of other race non-Hispanic or multiracial and 4% were of an unknown race or ethnicity. Additionally, approximately 80% of patients identified English as their primary language and 52% had public insurance.
In the Hispanic population, researchers reported that 19.5% of outpatients, 37.2% of CPCI patients who received CAR T, and 60.3% of patients who did not receive CAR T indicated the Spanish as preferred language (p <.01). Twelve patients enrolled in CAR T-cell clinical trials were unable to receive cells, 10 of whom received referrals from an outside hospital.
In addition to observing a lower proportion of Hispanic and Spanish-speaking patients in the external CAR T cohort compared to the CAR T CPCI cohort, there was also a lower proportion of female patients (30% vs 48%; p = 0.013). The socioeconomic status of the neighborhood was similar between both cohorts. In addition, the mean distance traveled from home was 498 miles in the external CAR T cohort versus 20 miles in the CPCI CAR T cohort (p <.0001).
The study had several limitations. The investigators were unable to assess the demographics of patients who were treated at outside institutions and did not receive a CAR T referral. As such, it was not possible to compare sociodemographic characteristics in eligible patients who received referrals and did not receive . In addition, 3 centers in the consortium saw the majority of patients, with 1 in particular having significant external referrals for CAR T. This distribution means that CAR T was administered unevenly, making patient access was a challenge.
reference
Hall AG, Winestone LE, Sullivan EM, et al. Access to CAR T-cell clinical trials in underrepresented populations: a multicenter cohort study of pediatric and young adult ALL patients. Trans Cell Ther. Published online March 24, 2023. doi:10.1016/j.jtct.2023.03.022