Journal article
Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma
British journal of haematology, Vol.194(4), pp.690-700
08/01/2021
DOI: 10.1111/bjh.17527
PMCID: PMC8457222
PMID: 34296427
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 <= 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.
Details
- Title: Subtitle
- Prophylactic corticosteroid use in patients receiving axicabtagene ciloleucel for large B-cell lymphoma
- Creators
- Olalekan O. Oluwole - Vanderbilt UniversityKrimo Bouabdallah - Centre Hospitalier Universitaire de BordeauxJavier Munoz - The University of Texas MD Anderson Cancer CenterSophie De Guibert - Hôpital PontchaillouJulie M. Vose - University of Nebraska Medical CenterNancy L. Bartlett - Washington University in St. LouisYi Lin - Mayo CLinic, Rochester, MN, USA,Abhinav Deol - Wayne State UniversityPeter A. McSweeney - Colorado Blood Cancer InstituteAndre H. Goy - Hackensack University Medical CenterMarie Jose Kersten - University of AmsterdamCaron A. Jacobson - Dana-Farber Cancer InstituteUmar Farooq - University of IowaMonique C. Minnema - Utrecht UniversityCatherine Thieblemont - Université Paris CitéJohn M. Timmerman - University of California, Los AngelesPatrick Stiff - Loyola University ChicagoIrit Avivi - Tel Aviv Sourasky Medical CenterDimitrios Tzachanis - University of California San DiegoJenny J. Kim - Kite (United States)Zahid Bashir - Kite (United States)Jeff McLeroy - Kite (United States)Yan Zheng - Kite (United States)John M. Rossi - Kite (United States)Lisa Johnson - Kite (United States)Lovely Goyal - Kite (United States)Tom van Meerten - University Medical Center Groningen
- Resource Type
- Journal article
- Publication Details
- British journal of haematology, Vol.194(4), pp.690-700
- DOI
- 10.1111/bjh.17527
- PMID
- 34296427
- PMCID
- PMC8457222
- NLM abbreviation
- Br J Haematol
- ISSN
- 0007-1048
- eISSN
- 1365-2141
- Publisher
- Wiley
- Number of pages
- 11
- Grant note
- Kite, a Gilead Company
- Language
- English
- Date published
- 08/01/2021
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984359691402771
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