替沙仑赛治疗年轻急性淋巴细胞白血病患者移植后复发：欧洲真实世界结局的决定因素
Tisagenlecleucel for post-transplant relapse in young acute lymphoblastic leukemia patients: European real-world determinants of outcome
这项研究要解决的问题是：造血干细胞移植（HSCT）后复发的B细胞急性淋巴细胞白血病（B-ALL）患者使用替沙仑赛（tisa-cel）后，哪些因素决定疗效。研究纳入欧洲31个中心的220例儿童和青年患者，中位随访30个月，2年无事件生存率为43.6%，总生存率为67.2%，CAR-T失败发生率为57.1%。结果显示，接受匹配同胞供者移植后复发的患者总生存更低、CAR-T失败率更高；移植后6个月内早期复发者2年无事件生存率仅23.7%，总生存率47.2%，明显差于晚期复发者；清淋时疾病负荷也影响结局，微小残留病阴性者2年总生存率81.7%，非缓解者为55.2%。这些因素可帮助识别移植后CAR-T失败风险较高的患者。
为什么推荐给您：替沙仑赛的常规真实世界队列研究，识别预后因素，属增量证据。
不需要生物学背景，多打比方
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摘要Abstract
This multicenter real-world study identifies critical determinants of outcome for tisagenlecleucel (tisa-cel) in treating post-HSCT relapse in 220 children/young adults with B-ALL from 31 European centers. Median follow-up was 30.0 months, with a 43.6% 2-year event-free survival (EFS), 67.2% overall-survival (OS), and 57.1% incidence of CAR-T failure. CAR-T for relapse after transplant from a matched sibling donor (MSD) compared to alternative donors was associated with lower 2-year-OS (MSD 59.1%, mismatched donor MMD 80.2%, matched family/unrelated donor MFD/MUD 68.3%, p = 0.046). Two-year incidence of CAR-T failure was highest for MSD (MSD 73.8%, MFD/MUD 49.7%, MMD 52.2%, p = 0.006). Patients who had relapsed early (< 6 months post HSCT) showed inferior 2-year-EFS (23.7%) and OS (47.2%) compared to patients with late relapse, ≥ 6 months after HSCT (EFS 49.8%, p = 0.001; OS 73.9%, p < 0.001). Early relapse was associated with a higher incidence of CAR-T failure and relapse after tisa-cel, particularly CD19+ relapses. Outcomes correlated with disease burden at lymphodepletion: 2-year-OS was 81.7% for MRD-, 69.2% for MRD+, and 55.2% for patients in non-remission (p = 0.003), with incidence of CAR-T failure highest in non-remission. Prior transplant from an MSD, early post-HSCT relapse, and disease burden at lymphodepletion identify patients at increased risk of CAR-T failure after HSCT.