Journal article
Long-term outcomes of patients with large B-cell lymphoma treated with axicabtagene ciloleucel and prophylactic corticosteroids
Bone marrow transplantation (Basingstoke), Vol.59(3), pp.366-372
03/2024
DOI: 10.1038/s41409-023-02169-z
PMCID: PMC10920180
PMID: 38177222
Abstract
ZUMA-1 safety management cohort 6 investigated the impact of prophylactic corticosteroids and earlier corticosteroids and/or tocilizumab on the incidence and severity of cytokine release syndrome (CRS) and neurologic events (NEs) following axicabtagene ciloleucel (axi-cel) in patients with relapsed/refractory large B-cell lymphoma (R/R LBCL). Prior analyses of cohort 6 with limited follow-up demonstrated no Grade ≥3 CRS, a low rate of NEs, and high response rates, without negatively impacting axi-cel pharmacokinetics. Herein, long-term outcomes of cohort 6 (N = 40) are reported (median follow-up, 26.9 months). Since the 1-year analysis (Oluwole, et al. Blood. 2022;138[suppl 1]:2832), no new CRS was reported. Two new NEs occurred in two patients (Grade 2 dementia unrelated to axi-cel; Grade 5 axi-cel-related leukoencephalopathy). Six new infections and eight deaths (five progressive disease; one leukoencephalopathy; two COVID-19) occurred. Objective and complete response rates remained at 95% and 80%, respectively. Median duration of response and progression-free survival were reached at 25.9 and 26.8 months, respectively. Median overall survival has not yet been reached. Eighteen patients (45%) remained in ongoing response at data cutoff. With ≥2 years of follow-up, prophylactic corticosteroids and earlier corticosteroids and/or tocilizumab continued to demonstrate CRS improvement without compromising efficacy outcomes, which remained high and durable.
Details
- Title: Subtitle
- Long-term outcomes of patients with large B-cell lymphoma treated with axicabtagene ciloleucel and prophylactic corticosteroids
- Creators
- Olalekan O Oluwole - Vanderbilt UniversityEdouard Forcade - Centre Hospitalier Universitaire de BordeauxJavier Muñoz - Banner MD Anderson Cancer CenterSophie de Guibert - Centre Hospitalier Universitaire de RennesJulie M Vose - University of Nebraska Medical CenterNancy L Bartlett - Washington University in St. Louis School of MedicineYi Lin - Mayo ClinicAbhinav Deol - Wayne State UniversityPeter McSweeney - Colorado Blood Cancer InstituteAndre H Goy - Hackensack Meridian HealthMarie José Kersten - University of AmsterdamCaron A Jacobson - Dana-Farber Cancer InstituteUmar Farooq - University of IowaMonique C Minnema - University Medical Center UtrechtCatherine Thieblemont - Assistance Publique – Hôpitaux de ParisJohn M Timmerman - University of California, Los AngelesPatrick Stiff - Loyola University ChicagoIrit Avivi - Tel Aviv UniversityDimitrios Tzachanis - University of California San DiegoYan Zheng - Kite (United States)Saran Vardhanabhuti - Kite (United States)Jenny Nater - Kite (United States)Rhine R Shen - Kite (United States)Harry Miao - Kite (United States)Jenny J Kim - Kite (United States)Tom van Meerten - University Medical Center Groningen
- Resource Type
- Journal article
- Publication Details
- Bone marrow transplantation (Basingstoke), Vol.59(3), pp.366-372
- DOI
- 10.1038/s41409-023-02169-z
- PMID
- 38177222
- PMCID
- PMC10920180
- NLM abbreviation
- Bone Marrow Transplant
- eISSN
- 1476-5365
- Grant note
- name: This study was funded by Kite, a Gilead Company
- Language
- English
- Electronic publication date
- 01/04/2024
- Date published
- 03/2024
- Academic Unit
- Hematology, Oncology, and Blood & Marrow Transplantation; Internal Medicine
- Record Identifier
- 9984542060002771
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