Prophylactic dexamethasone did not improve the safety or efficacy of axicabtagene ciloleucel (axi-cel) in patients with large B-cell lymphoma (LBCL), according to a study presented at the 2025 Transportation and Cellular Therapy Tandem Meetings of ASTCT and CIBMTR in Honolulu, Hawaii.
The study, which was led by Megan Melody, MD, MS, an assistant professor of medicine in the Department of Hematology, Oncology, and Cellular Therapy at the University of South Florida Tampa General Hospital Cancer Institute, suggests that prophylactic dexamethasone does not provide a clear clinical benefit to patients.
In the real-world setting, prophylactic dexamethasone is given to younger patients with a higher ECOG performance status at time of axi-cel infusion, and a subgroup in the ZUMA-1 clinical trial showed an improved safety profile of axi-cel when used with prophylactic dexamethasone, according to Dr. Melody and colleagues.
In this study, investigators analyzed 233 patients from seven institutions treated with axi-cel between 2018 and 2024. Of these, 50 (21.5%) received 10 mg of prophylactic dexamethasone from day 0 to day 2 of infusion. Patients who received prophylactic dexamethasone were younger (median 58 vs 63 years, P=0.04) and had a higher ECOG performance status (20.4% ECOG 2-3 vs 4.6%, P=0.001) at the time of infusion compared to those who did not.
Patients who received prophylactic dexamethasone had no significant reduction in cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS) compared to those who did not. The incidence, severity, and duration of CRS were similar between both groups (P=0.03), but patients who received dexamethasone had a higher rate of severe (Grade 4) ICANS (P=0.001). There was also no improvement in treatment outcomes, including complete response rates (30% vs. 42.6%, P=0.63), progression-free survival (248 vs 345 days, P=0.62), or overall survival (537 vs 656 days, P=0.61).
“The use of [prophylactic dexamethasone] did not significantly impact incidence or duration of treatment related toxicities; the use of [prophylactic dexamethasone] was associated with a higher incidence of grade 4 ICANS and the majority of [patients] who received [prophylactic dexamethasone] experienced CRS during the time of [dexamethasone] administration,” the investigators wrote. “[Prophylactic dexamethasone] did not impact response rates or survival with axi-cel.”
Reference
Melody M, Herr M, Grover N. No impact of prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma. Abstract #18. Presented at the Tandem Meetings | 2025 Transportation and Cellular Therapy Tandem Meetings of ASTCT and CIBMTR; February 12-15; Honolulu, Hawaii
