@article{f57832a53afd49038a683d91d2ad18d3,
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 × 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.",
keywords = "axi-cel, chimaeric antigen receptor-T cell, corticosteroids, cytokine release syndrome, large B-cell lymphoma, prophylaxis",
author = "Oluwole, {Olalekan O.} and Krimo Bouabdallah and Javier Mu{\~n}oz and {De Guibert}, Sophie and Vose, {Julie M.} and Bartlett, {Nancy L.} and Yi Lin and Abhinav Deol and McSweeney, {Peter A.} and Goy, {Andre H.} and Kersten, {Marie Jos{\'e}} and Jacobson, {Caron A.} and Umar Farooq and Minnema, {Monique C.} and Catherine Thieblemont and Timmerman, {John M.} and Patrick Stiff and Irit Avivi and Dimitrios Tzachanis and Kim, {Jenny J.} and Zahid Bashir and Jeff McLeroy and Yan Zheng and Rossi, {John M.} and Lisa Johnson and Lovely Goyal and {van Meerten}, Tom",
note = "Publisher Copyright: {\textcopyright} 2021 Kite, a Gilead Company. British Journal of Haematology published by British Society for Haematology and John Wiley & Sons Ltd.",
year = "2021",
month = aug,
doi = "10.1111/bjh.17527",
language = "אנגלית",
volume = "194",
pages = "690--700",
journal = "British Journal of Haematology",
issn = "0007-1048",
publisher = "John Wiley and Sons Inc.",
number = "4",
}