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加拿大 Axicabtagene Ciloleucel 治疗复发/难治性大 B 细胞淋巴瘤的真实世界结局

英文原题:Real-World Outcomes of Axicabtagene Ciloleucel for Treatment of Relapsed or Refractory Large B-Cell Lymphoma in Canada.

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Real-World Outcomes of Axicabtagene Ciloleucel for Treatment of Relapsed or Refractory Large B-Cell Lymphoma in Canada.

PubMed 2026/01/31(内容时间) Curr Oncol Q2 · IF 3.6(JCR 2025)

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研究概要

这些发现表明,其有效性和安全性特征与国际真实世界研究及 ZUMA-1 试验相当,支持将 axi-cel 作为广泛加拿大患者群体中的有效治疗方法。

中文摘要

CD19 CAR-T 细胞疗法显著改善了复发/难治性大B细胞淋巴瘤(R/R LBCL)患者的生存,在加拿大被视为符合条件的患者的标准治疗。Axicabtagene ciloleucel(axi-cel)是一种自体CAR-T 细胞疗法,最初由加拿大卫生部批准用于接受过2线或以上治疗的R/R LBCL成人患者。这项多中心分析利用从CIBMTR收集的登记数据,旨在呈现加拿大视角下axi-cel治疗R/R LBCL患者的真实世界经验。中位随访时间为12.4个月,所有患者的最佳客观缓解率(ORR)和完全缓解(CR)率分别为77%和59%。在12个月时,估计的无进展生存期(PFS)率和总生存期(OS)率分别为49%和59%。值得注意的是,与ZUMA-1和其他真实世界报告相比,该队列中不良事件的发生率和严重程度较低,CRS发生于77%的患者(3级,3%),ICANS发生于38%的患者(3级,10%)。结局在患者和疾病特征之间基本保持一致。这些发现表明,其有效性和安全性特征与国际真实世界研究和ZUMA-1试验相当,支持将axi-cel作为广泛加拿大患者群体中的有效治疗。

展开英文摘要原文

CD19 CAR T-cell therapy has significantly improved the survival of patients with relapsed or refractory large B cell lymphoma (R/R LBCL) and is considered standard of care for eligible patients in Canada. Axicabtagene ciloleucel (axi-cel) is an autologous CAR T-cell therapy, initially approved by Health Canada for adults with R/R LBCL after 2 or more lines of therapy. This multi-centre analysis, with registry data collected from CIBMTR, aims to present a Canadian perspective on the real-world experience of axi-cel in patients with R/R LBCL. With a median follow-up of 12.4 months, the best objective response rate (ORR) and complete response (CR) rate among all patients were 77% and 59%, respectively. At 12 months, estimated progression-free survival (PFS) and overall survival (OS) were 49% and 59%, respectively. Notably, the incidence and severity of adverse events were lower in this cohort compared to ZUMA-1 and other real-world reports, with CRS occurring in 77% (grade 3, 3%) and ICANS occurring in 38% (grade 3, 10%) of patients. Outcomes remained largely consistent across patient and disease characteristics. These findings demonstrate effectiveness and safety profiles comparable to international real-world studies and the ZUMA-1 trial, supporting the use of axi-cel as an effective treatment across broad Canadian populations.

论文信息

作者
Lemieux C、Kuruvilla J、Shafey M、Davison K、Paulson K、Li SZL、Billen L、Nissen F
第一作者单位
CHU de Québec-Université Laval, Université Laval, Québec, QC G1R 2J6, Canada.Canada
通讯作者单位
Department of Medicine, Arthur J.E. Child Comprehensive Cancer Centre, Calgary, AB T2N 5G2, Canada.Canada
期刊
Current oncology (Toronto, Ont.)2026 Jan 31
原文标识
PubMed 41744849 · DOI 10.3390/curroncol33020085