不适合移植的大 B 细胞淋巴瘤二线使用 axicabtagene ciloleucel:ALYCANTE 最终分析
Second-line axicabtagene ciloleucel in large B-cell lymphoma ineligible for transplantation: ALYCANTE final analysis.
CELL INTELLIGENCE · 肿瘤细胞治疗研究
肿瘤细胞治疗研究
英文原题:Clinical outcomes of tisagenlecleucel in relapsed/refractory diffuse large B-cell lymphoma: insights from a single-center study.
Clinical outcomes of tisagenlecleucel in relapsed/refractory diffuse large B-cell lymphoma: insights from a single-center study.
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CAR-T 已改变复发/难治性大 B 细胞淋巴瘤(RR-DLBCL)的治疗格局。本研究评估单中心 96 例接受 tisagenlecleucel(tisa-cel)治疗 RR-DLBCL 患者的真实世界疗效和毒性。接受桥接化疗的 81 例患者中,多数使用苯达莫司汀联合 rituximab(n = 48,46.9%);31 例(38.3%)对桥接化疗应答(完全缓解[CR]17.3%,部分缓解 21.0%)。Tisa-cel 输注后 1 个月 ORR 为 71.9%,3 个月降至 55.1%。中位 PFS 为 4.5 个月,1 年 PFS 为 33.3%;中位 OS 为 13.9 个月,1 年 OS 为 55.2%。3 个月时达到 CR 与 PFS 和 OS 显著改善相关。75% 患者发生 CRS(14.6% 为 3 级),22.9% 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。
结果显示患者获得显著生存获益且毒性可管理,支持 tisa-cel 作为 RR-DLBCL 可行的挽救治疗。
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.
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