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优化接受 axicabtagene ciloleucel、tisagenlecleucel 和 lisocabtagene maraleucel 治疗者的 CAR-T 治疗后监测期

英文原题:Optimizing the post-CAR T monitoring period in recipients of axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel.

查看英文原题

Optimizing the post-CAR T monitoring period in recipients of axicabtagene ciloleucel, tisagenlecleucel, and lisocabtagene maraleucel.

PubMed 2024/10/22(内容时间) Blood Adv Q1 · IF 7.7(JCR 2025)

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中文摘要

CD19 CAR-T 疗法(包括阿基仑赛、替沙仑赛和利基迈仑赛)改变了B细胞非霍奇金淋巴瘤治疗,但伴有CRS和免疫效应细胞相关神经毒性综合征等风险。FDA风险评估与缓解策略要求患者在治疗中心附近停留4周以监测和处理毒性,这虽审慎,却可能增加费用、加重患者家庭负担,并造成可及性及社会经济差异。本回顾性研究汇总9个中心2018至2023年475例接受上述CAR-T 患者的毒性起病和持续时间及非复发死亡原因。不同产品的CRS和神经毒性发生率及持续时间有所差异,但输注两周后新发CRS或神经毒性极少见。早期随访非复发死亡主要由神经毒性驱动,之后至输注后三个月则主要由感染导致。结果为优化CAR-T 监测提供依据,有望减少患者身体及经济负担。

展开英文摘要原文

CD19-directed chimeric antigen receptor T-cell (CAR T) therapies, including axicabtagene ciloleucel (axi-cel), tisagenlecleucel (tisa-cel), and lisocabtagene maraleucel (liso-cel), have transformed the treatment landscape for B-cell non-Hodgkin lymphoma, showcasing significant efficacy but also highlighting toxicity risks such as cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS). The US Food and Drug Administration has mandated patients remain close to the treatment center for 4 weeks as part of a Risk Evaluation and Mitigation Strategy to monitor and manage these toxicities, which, although cautious, may add to cost of care, be burdensome for patients and their families, and present challenges related to patient access and socioeconomic disparities.

This retrospective study across 9 centers involving 475 patients infused with axi-cel, tisa-cel, and liso-cel from 2018 to 2023 aimed to assess CRS and ICANS onset and duration, as well as causes of nonrelapse mortality (NRM) in real-world CAR T recipients. Although differences were noted in the incidence and duration of CRS and ICANS between CAR T products, new-onset CRS and ICANS are exceedingly rare after 2 weeks after infusion (0% and 0.

7% of patients, respectively). No new cases of CRS occurred after 2 weeks and a single case of new-onset ICANS occurred in the third week after infusion. NRM is driven by ICANS in the early follow-up period (1. 1% until day 28) and then by infection through 3 months after infusion (1. 2%).

This study provides valuable insights into optimizing CAR T therapy monitoring, and our findings may provide a framework to reduce physical and financial constraints for patients.

论文信息

作者
Ahmed N、Wesson W、Lutfi F、Porter DL、Bachanova V、Nastoupil LJ、Perales MA、Maziarz RT
第一作者单位
Division of Hematologic Malignancies and Cellular Therapeutics, The University of Kansas Cancer Center, Westwood, KS.
通讯作者单位
David and Etta Jonas Center for Cellular Therapy, The University of Chicago, Chicago, IL.United States
期刊
Blood advances2024 Oct 22
原文标识
PubMed 39042880 · DOI 10.1182/bloodadvances.2023012549