Outcomes of tisagenlecleucel versus allogeneic hematopoietic stem cell transplantation in relapsed or refractory large B-cell lymphoma

IF 3.2 3区医学 Q2 BIOTECHNOLOGY & APPLIED MICROBIOLOGY

Cytotherapy Pub Date : 2026-04-01 Epub Date: 2025-12-02 DOI:10.1016/j.jcyt.2025.102028

Tong-Yoon Kim , Kyoung Il Min , Gi-June Min , Youngwoo Jeon , Seung-Ah Yahng , Seok-Goo Cho , Ki-Seong Eom

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Abstract

Background

CD19-targeted chimeric antigen receptor (CAR)-T cell therapy has changed third-line treatment for relapsed/refractory large B-cell lymphoma (r/r LBCL). However, whether CAR-T therapy outperforms allogeneic hematopoietic stem cell transplantation (allo-HSCT) remains unclear. The aim of this study was to compare the real-world outcomes of tisagenlecleucel (Tisa-cel) CAR-T therapy versus allo-HSCT in adults with r/r LBCL, with a focus on survival, relapse, and nonrelapse mortality (NRM).

Methods

We conducted a retrospective analysis of adult patients treated with Tisa-cel (June 2022–October 2024) or allo-HSCT (April 2012–June 2023) at two Korean centers. Optimal cut-off points for continuous variables were determined using a survival-tree algorithm. Patient characteristics, overall survival (OS), progression-free survival (PFS), cumulative relapse, and NRM were compared between groups.

Results

In total, 127 patients were included (74 Tisa-cel, 53 allo-HSCT). Patients in the Tisa-cel group were older (median age of 61 versus 46 years) and had a higher proportion of high-risk disease than those in the allo-HSCT group. At 12 months, OS and PFS were similar between the two groups: OS was 50.1% and 45.3% with Tisa-cel and allo-HSCT (P = 0.784), respectively, and PFS was 40.8% and 35.9% (P = 0.819), respectively. NRM was significantly lower with Tisa-cel than with allo-HSCT (P = 0.009), although the cumulative incidence of relapse rates was similar (P = 0.066). Multivariable analysis identified poor response to bridging chemotherapy and refractory disease as predictors of inferior OS in both groups. An interval of less than 18 months from diagnosis to second relapse was independently associated with worse OS and PFS and a higher risk for relapse after allo-HSCT (P < 0.001); nonetheless, it did not affect outcomes after Tisa-cel therapy. The median OS for patients experiencing a relapse within 18 months was 9.5 months with Tisa-cel and 4.7 months with allo-HSCT. The poorer survival in the allo-HSCT group was primarily influenced by excess NRM.

Conclusions

Tisa-cel provides disease control comparable to allo-HSCT while markedly reducing NRM, resulting in a clear survival advantage when relapse occurs within 18 months of diagnosis. These real-world data support the earlier use of CAR-T therapy in the treatment course for high-risk r/r LBCL.

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复发或难治性大b细胞淋巴瘤的组织-白细胞与异体造血干细胞移植的结果

cd19靶向嵌合抗原受体(CAR)-T细胞疗法已经改变了复发/难治性大b细胞淋巴瘤（r/r LBCL）的三线治疗方法。然而，CAR-T疗法是否优于同种异体造血干细胞移植（allo-HSCT）仍不清楚。本研究的目的是比较组织细胞CAR-T治疗和同种异体造血干细胞移植在治疗晚期/晚期LBCL成人患者中的实际结果，重点关注生存率、复发和非复发死亡率（NRM）。方法回顾性分析韩国两家中心接受tisa - cell（2022年6月- 2024年10月）或同种异体造血干细胞移植（2012年4月- 2023年6月）治疗的成年患者。使用生存树算法确定连续变量的最优截止点。比较两组患者特征、总生存期（OS）、无进展生存期（PFS）、累积复发和NRM。结果共纳入127例患者（74例tisa - cell， 53例allo-HSCT）。与同种异体造血干细胞移植组相比，tisa细胞组患者年龄更大（中位年龄61岁对46岁），患高危疾病的比例更高。12个月时，两组的OS和PFS相似：Tisa-cel和alloo - hsct的OS分别为50.1%和45.3% (P = 0.784)， PFS分别为40.8%和35.9% （P = 0.819）。尽管累积复发率相似（P = 0.066），但Tisa-cel组的NRM明显低于同种异体造血干细胞组（P = 0.009）。多变量分析发现，对桥接化疗的不良反应和难治性疾病是两组患者较差OS的预测因素。从诊断到第二次复发的时间间隔小于18个月与更差的OS和PFS以及异位造血干细胞移植后复发的更高风险独立相关（P < 0.001）；尽管如此，它并不影响tisa细胞治疗后的结果。18个月内复发的患者的中位生存期（OS）： Tisa-cel组为9.5个月，同种异体移植组为4.7个月。同种异体造血干细胞移植组较差的生存率主要受过量NRM的影响。结论：与同种异体造血干细胞移植相比，stisa - cell提供了相当的疾病控制，同时显著降低了NRM，当诊断18个月内复发时，具有明显的生存优势。这些真实世界的数据支持CAR-T疗法在高风险r/r LBCL治疗过程中的早期使用。

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来源期刊

Cytotherapy 医学-生物工程与应用微生物

CiteScore

6.30

自引率

4.40%

发文量

683

审稿时长

49 days

期刊介绍： The journal brings readers the latest developments in the fast moving field of cellular therapy in man. This includes cell therapy for cancer, immune disorders, inherited diseases, tissue repair and regenerative medicine. The journal covers the science, translational development and treatment with variety of cell types including hematopoietic stem cells, immune cells (dendritic cells, NK, cells, T cells, antigen presenting cells) mesenchymal stromal cells, adipose cells, nerve, muscle, vascular and endothelial cells, and induced pluripotential stem cells. We also welcome manuscripts on subcellular derivatives such as exosomes. A specific focus is on translational research that brings cell therapy to the clinic. Cytotherapy publishes original papers, reviews, position papers editorials, commentaries and letters to the editor. We welcome "Protocols in Cytotherapy" bringing standard operating procedure for production specific cell types for clinical use within the reach of the readership.