Transplantation and cellular therapy · 2026
Impact of Prophylactic Steroids on CAR T-cell Related Toxicity for Relapsed and Refractory Non-Hodgkin Lymphoma.
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Habib Alma, Youssef Youssef, Welkie Rina Li, Butman Jacob, Bond David A, Sawalha Yazeed, Sigmund Audrey, Reneau John C, Alinari Lapo, Song No-Joon, Chan Wing, Krull Jordan, Rubinstein Mark P, Hanel Walter, Christian Beth, Baiocchi Robert A, Maddocks Kami, Brammer Jonathan, Sanchez-Pettito Gabriela, Shindiapina Polina, Choe Hannah, Wang Jiasheng, Voorhees Timothy J, Freud Aharon G, Vasu Sumithira, Wall Sarah, de Lima Marcos, Denlinger Nathan
Аннотация
BACKGROUND: Anti-CD19 chimeric antigen receptor T-cell therapy (CAR-T) has transformed the treatment of relapsed/refractory (R/R) non-Hodgkin lymphoma (NHL). However, toxicities including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) remain significant. Prophylactic corticosteroid use increased after cohort 6 of ZUMA-1, which suggested reduced severe CRS and ICANS, although the lack of a comparator arm limits interpretation.
OBJECTIVE: To evaluate the impact of steroid prophylaxis on outcomes and toxicities in a real-world setting.
STUDY DESIGN: We conducted a retrospective, single-institution analysis of adults (≥18 years) with R/R NHL treated with CD28 costimulated axicabtagene ciloleucel (axi-cel) or brexucabtagene autoleucel (brexu-cel) at The Ohio State University (2018-2023). All patients received steroid prophylaxis (dexamethasone 10 mg daily × 3 from infusion day). Outcomes including toxicities (CRS, ICANS) and response rates, survival outcomes, and hazard ratios were compared using logistic regression, log-rank test, and Cox model.
RESULTS: 137 patients received CAR-T (axi-cel n=118, brexu-cel n=19); 27.0% received steroid prophylaxis (PPX). Baseline characteristics were similar between groups, although primary refractory disease differed. CRS and ICANS prevalence did not significantly differ between cohorts. Any-grade CRS occurred in 97.3% of patients with PPX vs 88.0% with no PPX (p=0.13), with grade 3-4 CRS in 2.7% vs 12.0% (p=0.13). ICANS occurred in 75.7% vs 68.0% (p=0.38), with grade 3-4 ICANS in 24.3% vs 32.0% (p=0.38). Median time to CRS onset was delayed in the PPX group (4 vs 3 days, p<0.01), with no difference in ICANS onset. Overall response rates (ORR) were 75.7% vs 69.0% (p=0.44); complete response rates (CRR) were 62.2% vs 54.0% (p=0.39). OS and PFS did not differ.
CONCLUSION: Prophylactic corticosteroids did not impact CRS, ICANS, response rates, or survival. Although CRS onset may be modestly delayed, these findings do not support routine steroid prophylaxis in CAR-T-treated NHL patients.
OBJECTIVE: To evaluate the impact of steroid prophylaxis on outcomes and toxicities in a real-world setting.
STUDY DESIGN: We conducted a retrospective, single-institution analysis of adults (≥18 years) with R/R NHL treated with CD28 costimulated axicabtagene ciloleucel (axi-cel) or brexucabtagene autoleucel (brexu-cel) at The Ohio State University (2018-2023). All patients received steroid prophylaxis (dexamethasone 10 mg daily × 3 from infusion day). Outcomes including toxicities (CRS, ICANS) and response rates, survival outcomes, and hazard ratios were compared using logistic regression, log-rank test, and Cox model.
RESULTS: 137 patients received CAR-T (axi-cel n=118, brexu-cel n=19); 27.0% received steroid prophylaxis (PPX). Baseline characteristics were similar between groups, although primary refractory disease differed. CRS and ICANS prevalence did not significantly differ between cohorts. Any-grade CRS occurred in 97.3% of patients with PPX vs 88.0% with no PPX (p=0.13), with grade 3-4 CRS in 2.7% vs 12.0% (p=0.13). ICANS occurred in 75.7% vs 68.0% (p=0.38), with grade 3-4 ICANS in 24.3% vs 32.0% (p=0.38). Median time to CRS onset was delayed in the PPX group (4 vs 3 days, p<0.01), with no difference in ICANS onset. Overall response rates (ORR) were 75.7% vs 69.0% (p=0.44); complete response rates (CRR) were 62.2% vs 54.0% (p=0.39). OS and PFS did not differ.
CONCLUSION: Prophylactic corticosteroids did not impact CRS, ICANS, response rates, or survival. Although CRS onset may be modestly delayed, these findings do not support routine steroid prophylaxis in CAR-T-treated NHL patients.