@article{d4ceb700a74f42cd911005c983a1c8ef,
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 = "Funding Information: : consultancy or advisory role for Kite, a Gilead Company, Pfizer, Spectrum Pharmaceuticals, Legend, and Bayer. : honoraria from Kite, a Gilead Company, Takeda, Roche, and Celgene; consultancy or advisory role for Kite, a Gilead Company, Takeda, Roche, and Sandoz; travel support from Roche. : honoraria from Kyowa and Seattle Genetics; consultancy or advisory role for Pharmacyclics, Bayer, Kite, a Gilead Company, Pfizer, Janssen, Juno/Celgene, Bristol‐Myers Squibb, Kyowa, Alexion, Fosun Kite, Innovent, Seattle Genetics, and BeiGene; speakers{\textquoteright} bureau participation for Kite, a Gilead Company, Kyowa, Bayer, Pharmacyclics/Janssen, Seattle Genetics, Acrotech/Aurobindo, BeiGene, Verastem, AstraZeneca, Juno/Celgene/Bristol Myers Squibb, Genentech/Roche, and AbbVie; research funding from Bayer, Kite, a Gilead Company, Juno/Celgene/Bristol‐Myers Squibb, Merck, Portola, Incyte, Genentech, Pharmacyclics, Seattle Genetics, Janssen, and Millennium. : honoraria from Gilead Sciences, AbbVie, and Janssen; consultancy or advisory role for Gilead Sciences, AbbVie, and Janssen. : honoraria from Kite, a Gilead Company, AbbVie, Epizyme, Janssen, AstraZeneca, Verastem, Miltenyi, Loxo, Allogene, Wugen, Celgene, Roche, Genentech, and Karyopharm; consultancy or advisory role for AbbVie, Janssen, Kite, a Gilead Company, AstraZeneca, Verastem, Miltenyi, Loxo, Allogene, Wugen, Roche, Genentech, Karyopharm, and Morphosis; research funding from AstraZeneca, Bristol‐Myers Squibb, Incyte, Kite, a Gilead Company, Novartis, Seattle Genetics, Loxo, and Epizyme; travel support from Roche Pakistan. : consultancy or advisory role for ADC Therapeutics, Roche/Genentech, and Seattle Genetics; research funding from ADC Therapeutics, Autolus, Bristol‐Myers Squibb, Celgene, Forty Seven, Genentech, Janssen, Kite, a Gilead Company, Merck, Millennium, Pharmacyclics, and Seattle Genetics. : consultancy or advisory role for Kite, a Gilead Company, Janssen, Novartis, Celgene, Bluebird Bio, Juno, Legend, Sorrento, Gamida Cell, and Vineti; research funding from Kite, a Gilead Company, Janssen, Celgene, Bluebird Bio, Merck, and Takeda. : consultancy or advisory role for Janssen and Kite, a Gilead Company. : employment with Colorado Blood Cancer Institute Medical Group; consultancy or advisory role for, speakers' bureau participation for, and research funding from Kite, a Gilead Company. : employment with Regional Cancer Care Associates/OMI; leadership role at and stock or other ownership in Cancer Outcome Tracking Analysis (COTA); consultancy or advisory role for AstraZeneca, Celgene, Gilead Sciences, Kite, a Gilead Company, and Xcenda; research funding from Acerta, AstraZeneca, Celgene, Constellation, Genentech‐Hoffmann La Roche, Infinity, and Infinity Verastem. : honoraria from, consultancy or advisory role for, and travel support from Kite, a Gilead Company, Novartis, and Miltenyi; research funding from Roche, Takeda, and Celgene. : honoraria from Kite, a Gilead Company, Celgene, Novartis, Pfizer, Precision Biosciences, Nkarta, Lonza, and AbbVie; consultancy or advisory role for and travel support from Kite, a Gilead Company, Celgene, Novartis, Bristol‐Myers Squibb, Precision Biosciences, Nkarta, and Lonza; speakers' bureau participation for Axis and Clinical Care Options; research funding from Pfizer. : honoraria from Kite, a Gilead Company. : consultancy or advisory role for Gilead Sciences, Janssen Cilag, and Servier; research funding and travel support from Celgene. : honoraria from Gilead Sciences, Novartis, Celgene, Roche, and Janssen; consultancy or advisory role for Celgene, Roche, Novartis, and Janssen; research funding from Roche; travel support from Novartis, Roche, Gilead Sciences, and Janssen. : stock or other ownership in Genmab, Corvus, Marker Therapeutics, and Bluebird Bio; consultancy or advisory role for Kite, a Gilead Company, Celgene, Immune Design, and Celldex Therapeutics; research funding from Bristol‐Myers Squibb, Kite, a Gilead Company, Spectrum Pharmaceuticals, and Merck; travel support from Bristol‐Myers Squibb and Kite, a Gilead Company. : honoraria from and consultancy or advisory role for MorphoSys, Karyopharm, and Crispr; researching funding from Kite, a Gilead Company, Incyte, Amgen, Gamida Cell, Macrogenics, Cellectar, and Bristol‐Myers Squibb. : no relevant financial relationships to disclose. : consultancy or advisory role for Partner, Takeda, EUSA, Kite, a Gilead Company, Kyowa Kirin, and Magenta; speakers' bureau participation for Takeda and Kite, a Gilead Company; research funding from Bristol‐Myers Squibb, Kite, a Gilead Company, Genentech, Incyte, and Fate. and : employment with Kite, a Gilead Company; stock or other ownership in Gilead Sciences. : employment with Kite, a Gilead Company; stock or other ownership in OmniacPharmConsult Ltd. former employment with Kite, a Gilead Company. : employment with Kite, a Gilead Company, and Trillium Therapeutics; stock or other ownership in and patents, royalties, or other intellectual property from Trillium Therapeutics. : honoraria from Celgene; consultancy or advisory role for Kite, a Gilead Company. OOO KB JM SdG JMV NLB YL AD PAM AHG MJK CAJ UF MCM CT JMT PS IA DT JJK, JM, YZ, LG ZB JMR: LJ TvM 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 = "English",
volume = "194",
pages = "690--700",
journal = "British Journal of Haematology",
issn = "0007-1048",
publisher = "Wiley-Blackwell",
number = "4",
}