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

Olalekan O. Oluwole*, Krimo Bouabdallah, Javier Munoz, Sophie De Guibert, Julie M. Vose, Nancy L. Bartlett, Yi Lin, Abhinav Deol, Peter A. McSweeney, Andre H. Goy, Marie Jose Kersten, Caron A. Jacobson, Umar Farooq, Monique C. Minnema, Catherine Thieblemont, John M. Timmerman, Patrick Stiff, Irit Avivi, Dimitrios Tzachanis, Jenny J. KimZahid Bashir, Jeff McLeroy, Yan Zheng, John M. Rossi, Lisa Johnson, Lovely Goyal, Tom van Meerten

*Corresponding author for this work

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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 x 10(6) 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

Original languageEnglish
Pages (from-to)690-700
Number of pages11
JournalBritish Journal of Haematology
Volume194
Issue number4
Early online date22-Jul-2021
DOIs
Publication statusPublished - Aug-2021

Keywords

  • large B-cell lymphoma
  • axi-cel
  • chimaeric antigen receptor-T cell
  • prophylaxis
  • corticosteroids
  • cytokine release syndrome
  • CYTOKINE RELEASE SYNDROME
  • PROPENSITY-SCORE
  • MANAGEMENT
  • THERAPY

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