학술논문
Long-term outcomes of patients with large B-cell lymphoma treated with axicabtagene ciloleucel and prophylactic corticosteroids
Document Type
Original Paper
Author
Oluwole, Olalekan O.; Forcade, Edouard; Muñoz, Javier; de Guibert, Sophie; Vose, Julie M.; Bartlett, Nancy L.; Lin, Yi; Deol, Abhinav; McSweeney, Peter; Goy, Andre H.; Kersten, Marie José; Jacobson, Caron A.; Farooq, Umar; Minnema, Monique C.; Thieblemont, Catherine; Timmerman, John M.; Stiff, Patrick; Avivi, Irit; Tzachanis, Dimitrios; Zheng, Yan; Vardhanabhuti, Saran; Nater, Jenny; Shen, Rhine R.; Miao, Harry; Kim, Jenny J.; van Meerten, Tom
Source
Bone Marrow Transplantation: Official journal of the European Society for Blood and Marrow Transplantation. 59(3):366-372
Subject
Language
English
ISSN
0268-3369
1476-5365
1476-5365
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.