Investigators highlight the importance of building partnerships between CAR T-cell centers and external hospitals to increase treatment referrals and access to clinical trials for patients with B-cell acute lymphoblastic leukemia.
Pediatric and young adult patients with relapsed/refractory B-cell acute lymphoblastic leukemia (B-ALL) who are Hispanic, predominantly speak Spanish, or are publicly insured appear to be underrepresented in being referred from external hospitals to CAR T-cell centers than those treated at consortium sites and enrolled on a clinical CAR T trial, according to findings from a cohort study published in Transplantation and Cellular Therapy.
In a population of 337 patients with B-ALL, 112 received a referral from an external hospital to a consortium site and proceeded to enroll on a CAR T-cell therapy study. Additionally, 225 patients were primarily treated at a consortium site, 34% of whom enrolled in a CAR T study. Those who were treated at a consortium site were found to have comparable characteristics.
Investigators reported that fewer Hispanic patients (37% vs 56%; P = .03), those who primarily spoke Spanish (8% vs 22%; P = .006), and those with public insurance (38% vs 65%; P = .001) were referred from external hospitals vs those who were primarily treated at consortium sites and enrolled in a clinical CAR T-cell therapy study.
Investigators conducted the multicenter, retrospective cohort trial through the Consortium for Pediatric Cellular Immunotherapy (CPCI), which was designed to hasten access to pediatric immunotherapy studies for potentially fatal disorders.
The study included patients with relapsed/refractory B-ALL aged 0 to 27 years who underwent 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 external hospital to a CPCI site before enrolling on a CAR T-cell trial.
Of the patients who enrolled on the trial, 44% were Hispanic, 36% were non-Hispanic White, 2% were non-Hispanic Black, 5% were non-Hispanic Asian, 10% were another non-Hispanic race 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, investigators reported that 19.5% of external patients, 37.2% of CPCI patients who received CAR T, and 60.3% of patients who did not receive CAR T listed Spanish as their preferred language (P <.01). Twelve patients who enrolled in clinical CAR T-cell trials were not able receive cells, 10 of whom received referrals from an external hospital.
In addition to observing a lower proportion of Hispanic and Spanish speaking patients in the external CAR T cohort vs the CPCI CAR T cohort, there was also a lower proportion of female patients (30% vs 48%; P = .013). Neighborhood socioeconomic status was similar between both cohorts. Additionally, the median distance travelled from home was 498 miles in the external CAR T cohort vs 20 miles in the CPCI CAR T cohort (P <.0001).
The study had several limitations. Investigators were not able to assess the demographics of patients who were treated at external institutions and did not receive a CAR T referral. As such, it was not possible to compare sociodemographic characteristics in eligible patients who did and did not receive referrals. Moreover, 3 consortium centers 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 a challenge.
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