Stanford University School of Medicine, Stanford, CA
Panayiotis Vandris , Karen Chao , Christina Baggott , Christine L. Phillips , Muna Qayed , Jenna Rossoff , Stephanie J. Si Lim , Lena E. Winestone , Heather E. Stefanski , Julie-An M. Talano , Steven Margossian , Michael R. Verneris , Gary Douglas Myers , Nicole A. Karras , Patrick A. Brown , Prakash Satwani , Crystal Mackall , Kevin J. Curran , Theodore Willis Laetsch , Liora M. Schultz
Background: Population-level data show significantly inferior outcomes for Hispanic children, adolescents, and young adults (CAYA) diagnosed with B-cell acute lymphoblastic leukemia (B-ALL) relative to non-Hispanic whites (NHW). Here, we compare outcomes between Hispanic and NHW CAYA patients with relapsed and/or refractory (RR) B-ALL receiving tisagenlecleucel, a CD19-specific chimeric antigen receptor (CAR) T cell therapy. Methods: We used data from the Pediatric Real World CAR Consortium retrospective cohort of 200 patients who underwent cell shipment for standard-of-care tisagenlecleucel between August 2017 and March 2020 (N=15 US institutions). Race/ethnicity was identified by medical record review. Patients reported as belonging to more than one racial/ethnic group were classified as multiracial and excluded from analysis. Baseline factors, outcomes, and safety post-infusion were characterized for Hispanic vs. NHW infused patients. Outcomes included complete response (CR) rate, overall survival (OS), duration of response (DOR), and duration of B-cell aplasia (DBA). A multivariate Cox model for OS was constructed, including all baseline factors. Results: Among 185 infused patients, 90 (48.6%) were NHW and 70 (37.8%) were Hispanic. Among 15 non-infused patients, 3 (20.0%) were NHW and 5 (33.3%) were Hispanic. Hispanic patients were significantly older at diagnosis (mean: 10.7 vs. 8.3 years, p=0.02) and had significantly shorter time from diagnosis to infusion (mean: 34.4 vs. 46.4 months, p=0.04). Hispanic and NHW patients did not significantly differ across sex, leukemia type, number of prior lines of therapy, receipt of prior CD19-directed therapy, level of disease burden pre-infusion, and number of relapses pre-infusion. Hispanic and NHW patients did not significantly differ across 1-month CR, 6-month OS, 1-year OS, 18-month OS, 6-month DOR, 1-year DOR, 6-month DBA, and 1-year DBA (Table). On multivariate analysis including the above covariates, OS did not significantly differ for Hispanic patients (HR=1.04, p=0.92). Hispanic and NHW patients did not significantly differ across grade ≥ 3 cytokine release syndrome, grade ≥ 3 neurotoxicity, grade 4 neutropenia, tumor lysis syndrome, or number of infections post-infusion. Conclusions: Outcomes were similar between Hispanic and NHW CAYA RR B-ALL patients receiving tisagenlecleucel in the real-world setting. Increasing access to CAR therapy among Hispanic CAYA B-ALL patients could help mitigate population-level disparities in outcomes observed after receipt of conventional therapies.
Outcome (%) | Hispanic | NHW | P-value |
---|---|---|---|
1-month CR | 81.4 | 88.8 | 0.19 |
6-month OS | 89.7 | 83.4 | 0.82 |
1-year OS | 71.9 | 71.2 | 0.62 |
18-month OS | 68.2 | 71.2 | 0.62 |
6-month DOR | 74.2 | 72.8 | 0.34 |
1-year DOR | 62.3 | 60.7 | 0.42 |
6-month DBA | 59.5 | 64.7 | 0.87 |
1-year DBA | 52.1 | 50.0 | 0.85 |
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