肿瘤细胞治疗研究
英文原题：Outcomes of tisagenlecleucel versus allogeneic hematopoietic stem cell transplantation in relapsed or refractory large B-cell lymphoma.
Outcomes of tisagenlecleucel versus allogeneic hematopoietic stem cell transplantation in relapsed or refractory large B-cell lymphoma.
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Tisa-cel 提供的疾病控制与 allo-HSCT 相当，同时显著降低 NRM，当诊断后 18 个月内复发时可带来明显的生存优势。
**背景：**CD19靶向嵌合抗原受体（CAR）T细胞疗法改变了复发/难治性大B细胞淋巴瘤（r/r LBCL）的三线治疗，但其是否优于异基因造血干细胞移植（allo-HSCT）尚不明确。本研究比较成人r/r LBCL患者接受替沙仑赛（Tisa-cel）CAR-T 或allo-HSCT的真实世界生存、复发及非复发死亡率（NRM）。 **方法：**回顾性分析韩国两家中心接受Tisa-cel（2022年6月至2024年10月）或allo-HSCT（2012年4月至2023年6月）的成人患者。连续变量的最佳截断值通过生存树算法确定，并比较患者特征、总生存期（OS）、无进展生存期（PFS）、累积复发及NRM。 **结果：**共纳入127例患者（Tisa-cel组74例，allo-HSCT组53例）。Tisa-cel组患者年龄较大（中位年龄61比46岁），高危疾病比例也更高。12个月时两组OS和PFS相近：Tisa-cel与allo-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）。Tisa-cel组NRM显著较低（P=0.009），而累积复发率相近（P=0.066）。多变量分析显示，桥接化疗应答不佳和难治性疾病均预测两组OS较差。从诊断至第二次复发间隔不足18个月与OS、PFS较差及allo-HSCT后复发风险较高独立相关（P<0.001），但不影响Tisa-cel治疗结局。复发间隔不足18个月者，中位OS在Tisa-cel组为9.5个月，allo-HSCT组为4.7个月。allo-HSCT组生存较差主要受较高NRM影响。 **结论：**Tisa-cel可提供与allo-HSCT相当的疾病控制，同时显著降低NRM；当诊断后18个月内复发时，表现出明确生存优势。这些真实世界数据支持在高危r/r LBCL治疗过程中更早使用CAR-T。
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).
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.
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.
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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