肿瘤细胞治疗研究
英文原题：Drivers of temporal improvement in CAR T-cell therapy for large B-cell lymphoma: a Japanese nationwide registry analysis.
Drivers of temporal improvement in CAR T-cell therapy for large B-cell lymphoma: a Japanese nationwide registry analysis.
本研究分析了日本登记数据库中913例R/R LBCL患者，并比较了两个时间段（2019-2021年 vs 2022-2024年）的结局。
真实世界CD19嵌合抗原受体（CAR）T细胞治疗大B细胞淋巴瘤（LBCL）的特点是适应人群扩大和治疗管理实践的不断演变。然而，这些变化的预后影响仍不一致，且结局的具体驱动因素仍不明确。本研究分析了来自日本登记数据库的913例复发/难治性（R/R）LBCL患者，并比较了两个时间段（2019-2021年 vs 2022-2024年）的结局。2022-2024年队列患者年龄更大、不良基线特征更多、既往治疗更少。治疗模式已转向二线治疗使用率更高、对axicabtagene ciloleucel（axi-cel）和lisocabtagene maraleucel（liso-cel）的偏好增加，以及输注前疾病控制改善。相应地，2022-2024年队列获得了更长的无进展生存期（PFS；6个月PFS，63.2% vs 55.2%；P = .005），在使用倾向性评分匹配校正基线特征后这一结果仍然存在。多因素分析确定二线治疗、输注前疾病控制改善以及产品选择从tisagenlecleucel转向axi-cel或liso-cel是这一改善的主要驱动因素。这一获益在高危人群中尤为明显，包括输注时疾病稳定或进展的患者（6个月PFS，54.6% vs 43.8%；P = .012）以及对一线治疗难治的患者（6个月PFS，51.7% vs 40.3%；P = .013）。尽管在更高危人群中应用更广泛且axi-cel暴露更多，6个月非复发死亡率仍较低（2.1% vs 1.5%）。CD19 CAR T细胞疗法治疗R/R LBCL的真实世界结局有所改善，主要由二线治疗、输注前疾病控制的增强以及更高效CAR T产品的更多使用所驱动。
Real-world CD19 chimeric antigen receptor (CAR) T-cell therapy for large B-cell lymphoma (LBCL) is characterized by expanded eligibility and evolving management practices. However, the prognostic impact of these changes remains inconsistent, and the specific drivers of outcomes remain unclear. This study analyzed 913 patients with relapsed/refractory (R/R) LBCL from a Japanese registry and compared the outcomes between 2 calendar periods (2019-2021 vs 2022-2024). The 2022-2024 cohort was older, had more adverse baseline features, and was less pretreated. Treatment patterns have shifted toward higher utilization of second-line therapy, a growing preference for axicabtagene ciloleucel (axi-cel) and lisocabtagene maraleucel (liso-cel), and improved disease control before infusion. Accordingly, the 2022-2024 cohort achieved a longer progression-free survival (PFS; 6-month PFS, 63.2% vs 55.2%; P = .005), which persisted after adjusting for baseline characteristics using propensity score matching. Multivariable analysis identified second-line therapy, improved preinfusion disease control, and a shift in product selection from tisagenlecleucel to axi-cel or liso-cel as the primary drivers of this improvement. This benefit was pronounced in high-risk populations, including patients with stable or progressive disease at infusion (6-month PFS, 54.6% vs 43.8%; P = .012) and those who were refractory to first-line therapy (6-month PFS, 51.7% vs 40.3%; P = .013). Despite broader use in higher-risk populations and greater axi-cel exposure, 6-month nonrelapse mortality remained low (2.1% vs 1.5%). Real-world outcomes of CD19 CAR T-cell therapy for R/R LBCL have improved, predominantly driven by second-line therapy, enhanced preinfusion disease control, and increased use of more potent CAR T products.
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