期刊
BRITISH JOURNAL OF HAEMATOLOGY
卷 194, 期 4, 页码 690-700出版社
WILEY
DOI: 10.1111/bjh.17527
关键词
large B-cell lymphoma; axi-cel; chimaeric antigen receptor-T cell; prophylaxis; corticosteroids; cytokine release syndrome
类别
资金
- Kite, a Gilead Company
Prophylactic corticosteroids and earlier intervention with corticosteroids and/or tocilizumab resulted in a reduced rate of severe treatment-related toxicities and high response rates in patients with refractory large B-cell lymphoma. The majority of patients did not experience CRS or NEs within 72 hours of axi-cel treatment. Furthermore, 95% of patients achieved objective responses and 80% achieved complete responses in this study.
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 <= 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 center dot 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.
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