Department of Hematology, University Hospitals Leuven, Leuven, Belgium.
Acta Clin Belg. 2024 Aug;79(4):276-284. doi: 10.1080/17843286.2024.2399365. Epub 2024 Sep 18.
INTRODUCTION: Large B-cell lymphomas (LBCL) are the most frequently aggressive B-cell non-Hodgkin lymphomas. Anti-CD19 chimeric antigen receptor (CAR)-T cell therapy has emerged as a new, powerful treatment for relapsed or refractory (R/R) disease. Two CAR-T cell products, tisagenlecleucel (tisa-cel,) and axicabtagene ciloleucel (axi-cel), are reimbursed in Belgium for R/R LBCL beyond second line. OBJECTIVES AND METHODS: We conducted a retrospective cohort study to report the outcome with tisa-cel and axi-cel for R/R LBCL beyond second line in the years 2019-2023 at the University Hospitals Leuven for 79 patients selected for apheresis and CAR-T infusion. RESULTS: Eleven patients (14%) did not proceed to CAR-T cell infusion. For infused patients ( = 68), the best overall response rate (ORR)/complete response (CR) rate was 64%/49% for tisa-cel and 88%/66% for axi-cel ( = 0.04 for ORR). After a median follow-up of 13.8 months, progression-free survival (PFS) and overall survival (OS) at 1 year were 30% and 43% for tisa-cel and 48% and 62% for axi-cel. Cytokine release syndrome (CRS) (all grades/grade ≥3) occurred in 82%/9% after tisa-cel and in 97%/0% after axi-cel. Immune effector cell-associated neurotoxicity syndrome (ICANS) (all grades/grade ≥3) occurred in 24%/18% after tisa-cel and in 54%/40% after axi-cel. The non-relapse mortality in the infusion cohort was 13%. CONCLUSION: Our real-world data show high and durable response rates, with a non-significant trend towards a higher efficacy and higher toxicity for axi-cel compared to tisa-cel. Our results are in line with other real-world registries except for a shorter median OS and more high-grade ICANS.
简介：大 B 细胞淋巴瘤（LBCL）是最常见的侵袭性 B 细胞非霍奇金淋巴瘤。抗 CD19 嵌合抗原受体（CAR）-T 细胞疗法已成为治疗复发或难治性（R/R）疾病的一种新的、强大的治疗方法。两种 CAR-T 细胞产品，tisagenlecleucel（tisa-cel）和 axicabtagene ciloleucel（axi-cel），在比利时被报销用于二线以上复发或难治性 LBCL。 目的和方法：我们进行了一项回顾性队列研究，报告了 2019 年至 2023 年在鲁汶大学医院接受二线以上复发或难治性 LBCL 患者接受 tisa-cel 和 axi-cel 治疗的结果，共 79 例患者接受了单采和 CAR-T 输注。 结果：11 例（14%）患者未进行 CAR-T 细胞输注。对于输注患者（ = 68），tisa-cel 的最佳总缓解率（ORR）/完全缓解率（CR）为 64%/49%，axi-cel 为 88%/66%（ORR 无统计学意义）。中位随访 13.8 个月后，tisa-cel 的 1 年无进展生存率（PFS）和总生存率（OS）分别为 30%和 43%，axi-cel 分别为 48%和 62%。tisa-cel 后发生细胞因子释放综合征（CRS）（所有级别/≥3 级）为 82%/9%，axi-cel 后为 97%/0%。tisa-cel 后发生免疫效应细胞相关神经毒性综合征（ICANS）（所有级别/≥3 级）为 24%/18%，axi-cel 后为 54%/40%。输注队列的非复发死亡率为 13%。 结论：我们的真实世界数据显示，高且持久的缓解率，axi-cel 与 tisa-cel 相比，疗效有非显著趋势更高，毒性更高。我们的结果与其他真实世界登记处一致，除了中位 OS 更短和更高等级的 ICANS 更多。
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