1. Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B‐cell lymphoma
- Author
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Oluwole, Olalekan O, Bouabdallah, Krimo, Muñoz, Javier, De Guibert, Sophie, Vose, Julie M, Bartlett, Nancy L, Lin, Yi, Deol, Abhinav, McSweeney, Peter A, Goy, Andre H, Kersten, Marie José, Jacobson, Caron A, Farooq, Umar, Minnema, Monique C, Thieblemont, Catherine, Timmerman, John M, Stiff, Patrick, Avivi, Irit, Tzachanis, Dimitrios, Kim, Jenny J, Bashir, Zahid, McLeroy, Jeff, Zheng, Yan, Rossi, John M, Johnson, Lisa, Goyal, Lovely, and Meerten, Tom
- Subjects
Biomedical and Clinical Sciences ,Oncology and Carcinogenesis ,Lymphoma ,Rare Diseases ,Cancer ,Hematology ,Clinical Research ,6.1 Pharmaceuticals ,Evaluation of treatments and therapeutic interventions ,Adrenal Cortex Hormones ,Adult ,Aged ,Aged ,80 and over ,Antineoplastic Agents ,Immunological ,Biological Products ,Cytokine Release Syndrome ,Dexamethasone ,Female ,Humans ,Immunotherapy ,Adoptive ,Lymphoma ,Large B-Cell ,Diffuse ,Male ,Middle Aged ,large B-cell lymphoma ,axi-cel ,chimaeric antigen receptor-T cell ,prophylaxis ,corticosteroids ,cytokine release syndrome ,Cardiorespiratory Medicine and Haematology ,Immunology ,Cardiovascular medicine and haematology - 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 × 106 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.
- Published
- 2021