Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma. Journal Article

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Authors: Oluwole, OO; Bouabdallah, K; Muñoz, J; De Guibert, S; Vose, JM; Bartlett, NL; Lin, Y; Deol, A; McSweeney, PA; Goy, AH; Kersten, MJ; Jacobson, CA; Farooq, U; Minnema, MC; Thieblemont, C; Timmerman, JM; Stiff, P; Avivi, I; Tzachanis, D; Kim, JJ; Bashir, Z; McLeroy, J; Zheng, Y; Rossi, JM; Johnson, L; Goyal, L; van Meerten, T
Article Title: Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma.
Abstract: ZUMA-1 (NCT02348216) examined the safety and efficacy of axicabtagene ciloleucel (axi-cel), an autologous CD19-directed chimaeric antigen receptor (CAR)-T cell therapy, in refractory large B-cell lymphoma. To reduce treatment-related toxicity, several exploratory safety management cohorts were added to ZUMA-1. Specifically, cohort 6 investigated management of cytokine release syndrome (CRS) and neurologic events (NEs) with prophylactic corticosteroids and earlier corticosteroid and tocilizumab intervention. CRS and NE incidence and severity were primary end-points. Following leukapheresis, patients could receive optional bridging therapy per investigator discretion. All patients received conditioning chemotherapy (days -5 through -3), 2 × 10 CAR-T cells/kg (day 0) and once-daily oral dexamethasone [10 mg, day 0 (before axi-cel) through day 2]. Forty patients received axi-cel. CRS occurred in 80% of patients (all grade =2). Any grade and grade 3 or higher NEs occurred in 58% and 13% of patients respectively. Sixty-eight per cent of patients did not experience CRS or NEs within 72 h of axi-cel. With a median follow-up of 8·9 months, objective and complete response rates were 95% and 80% respectively. Overall, prophylactic corticosteroids and earlier corticosteroid and/or tocilizumab intervention resulted in no grade 3 or higher CRS, a low rate of grade 3 or higher NEs and high response rates in this study population.
Journal Title: British journal of haematology
ISSN: 1365-2141; 0007-1048
Publisher: Blackwell Publishing Ltd  
Date Published: 2021