肿瘤细胞治疗研究
英文原题：Real-World Outcomes of Tisagenlecleucel Versus Standard-of-Care Salvage Chemotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Propensity Score-Matched Analysis From Korea.
Real-World Outcomes of Tisagenlecleucel Versus Standard-of-Care Salvage Chemotherapy in Relapsed or Refractory Diffuse Large B-Cell Lymphoma: A Propensity Score-Matched Analysis From Korea.
在这项来自亚洲的真实世界倾向性评分匹配比较中，tisagenlecleucel 在韩国 R/R DLBCL 患者中显示出优于 SOC 挽救化疗的生存和缓解结局，支持其作为 3L 治疗标准方案的地位。
Tisagenlecleucel是一种靶向CD19的CAR-T 细胞疗法，在复发或难治性（R/R）弥漫大B细胞淋巴瘤（DLBCL）中已显示出持久的疗效。然而，在亚洲人群中，其与标准治疗（SOC）疗法相比较的真实世界数据仍然匮乏。
我们在韩国两家三级医院开展了一项回顾性、倾向评分匹配队列研究。在第三线（3L）或更后线治疗中接受治疗的R/R DLBCL成人患者，接受了tisagenlecleucel（CAR-T队列）或SOC挽救性化疗免疫治疗。使用年龄、性别、治疗线数、国际预后指数、东部肿瘤协作组状态和诊断年份进行倾向评分匹配（1:1）。结局包括缓解率、无进展生存期（PFS）、总生存期（OS）和安全性。
在178例符合条件的患者中（CAR-T组67例，SOC组111例），共匹配100例（每组50例）。CAR-T组的总缓解率显著更高（68% vs. 28%），完全缓解率也更高（60% vs. 22%）。CAR-T组的中位PFS为4.8个月，SOC组为1.6个月（风险比[HR]，0.49；P = 0.003）；中位OS分别为11.9个月 vs. 3.3个月（HR，0.51；P = 0.013）。亚组分析在大多数临床分层中普遍支持CAR-T。CAR-T毒性可控，观察到细胞因子释放综合征（16%）和神经毒性（6%），而SOC方案与更高的化疗相关血细胞减少有关。
BACKGROUND: Tisagenlecleucel, a CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy, has shown durable efficacy in relapsed or refractory (R/R) diffuse large B-cell lymphoma (DLBCL). However, comparative real-world data against standard-of-care (SOC) therapies remain scarce in Asian populations. METHODS: We performed a retrospective, propensity score-matched cohort study at two tertiary hospitals in Korea. Adult patients with R/R DLBCL treated in the third-line (3L) or later setting received either tisagenlecleucel (CAR-T cohort) or SOC salvage chemoimmunotherapy. Propensity score matching (1:1) was conducted using age, sex, line of therapy, International Prognostic Index, Eastern Cooperative Oncology Group status, and year of diagnosis. Outcomes included response rates, progression-free survival (PFS), overall survival (OS), and safety. RESULTS: Among 178 eligible patients (CAR-T, n = 67; SOC, n = 111), 100 were matched (50 per group). The CAR-T cohort achieved a significantly higher overall response rate (68% vs. 28%) and complete response rate (60% vs. 22%). Median PFS was 4.8 months for CAR-T vs. 1.6 months for SOC (hazard ratio [HR], 0.49; P = 0.003), and median OS was 11.9 months vs. 3.3 months (HR, 0.51; P = 0.013). Subgroup analyses generally favored CAR-T across most clinical strata. CAR-T toxicities were manageable, with cytokine release syndrome (16%) and neurotoxicity (6%) observed, while SOC regimens were associated with higher chemotherapy-related cytopenias. CONCLUSION: In this real-world propensity score-matched comparison from Asia, tisagenlecleucel demonstrated superior survival and response outcomes compared with SOC salvage chemotherapy in Korean patients with R/R DLBCL, supporting its role as the standard of care in the 3L setting.
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