Yoon Sang Eun, Cho Junhun, Cho Duck, Kang Eun-Sook, Kim Seok Jin, Kim Won Seog
Division of Hematology-Oncology, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-Ro, Gangnam-Gu, Seoul, 06351, Korea.
Department of Pathology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Int J Hematol. 2025 Aug 22. doi: 10.1007/s12185-025-04006-z.
Chimeric antigen receptor (CAR) T-cell therapy has transformed the treatment landscape for relapsed and refractory large B-cell lymphoma (RR-DLBCL). This study evaluated the real-world efficacy and toxicities of 96 patients with RR-DLBCL who received tisagenlecleucel (tisa-cel) at a single institution. Among 81 patients who received bridging chemotherapy, most received a bendamustine and rituximab regimen (n = 48, 46.9%), and 31 (38.3%) responded to bridging chemotherapy (17.3% complete remission [CR] and 21.0% partial remission). Tisa-cel showed an overall response rate (ORR) of 71.9% at 1 month, which declined to 55.1% at 3 months. The median progression-free survival (PFS) was 4.5 months, with 1-year PFS at 33.3%. Median overall survival (OS) was 13.9 months, with a 1-year OS rate of 55.2%. Achieving CR at 3 months was correlated with significantly improved PFS and OS. Cytokine release syndrome occurred in 75% of patients (14.6% grade ≥ 3) and immune effector cell-associated neurotoxicity syndrome occurred in 22.9% of patients (7.3% grade ≥ 3). All adverse events were managed effectively. The results demonstrated significant survival benefits with manageable toxicities, supporting tisa-cel as a viable salvage therapy for RR-DLBCL.
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(RR-DLBCL)的治疗格局。本研究评估了在单一机构接受替沙格宁(tisa-cel)治疗的96例RR-DLBCL患者的真实疗效和毒性。在81例接受桥接化疗的患者中,大多数接受了苯达莫司汀和利妥昔单抗方案(n = 48,46.9%),31例(38.3%)对桥接化疗有反应(17.3%完全缓解[CR],21.0%部分缓解)。替沙格宁在1个月时的总缓解率(ORR)为71.9%,在3个月时降至55.1%。中位无进展生存期(PFS)为4.5个月,1年PFS率为33.3%。中位总生存期(OS)为13.9个月,1年OS率为55.2%。在3个月时达到CR与PFS和OS的显著改善相关。75%的患者发生细胞因子释放综合征(14.6%为≥3级),22.9%的患者发生免疫效应细胞相关神经毒性综合征(7.3%为≥3级)。所有不良事件均得到有效管理。结果表明,替沙格宁具有显著的生存获益且毒性可控,支持其作为RR-DLBCL可行的挽救疗法。