National Clinical Research Center for Hematologic Diseases, Jiangsu Institute of Hematology, The First Affiliated Hospital of Soochow University, Suzhou 215006, China; Institute of Blood and Marrow Transplantation, Collaborative Innovation Center of Hematology, Soochow University, Suzhou 215123, China.
East China Normal University, Shanghai 200062, China; Shanghai Unicar-Therapy Bio-medicine Technology Co., Ltd, Shanghai 201203, China.
Leuk Res. 2024 Oct;145:107569. doi: 10.1016/j.leukres.2024.107569. Epub 2024 Aug 22.
We aimed to evaluate the efficacy of decitabine consolidation after treatment with CD19/CD22 chimeric antigen receptor T-cell (CAR-T) for patients with relapsed/refractory B-cell acute lymphoblastic leukaemia (r/r B-ALL).
We retrospectively analysed 48 patients with r/r B-ALL who received CD19/CD22 CAR-T therapy between September 2017 and May 2021. Sixteen patients received decitabine consolidation (20 mg/m/day for 5 days at 3-month intervals) after CAR-T therapy (DAC group), while 32 patients did not receive decitabine consolidation (CON group). Overall survival (OS), leukaemia-free survival (LFS), and cumulative incidence of relapse (CIR) were evaluated in both groups. Time-to-event analysis was performed using the Kaplan-Meier method.
The median follow-up periods in the DAC and CON groups were 41.2 months and 28.6 months, respectively. The 4-year OS and 4-year LFS rates in both groups were 93.3 % and 64.3 % (P=0.029) and 87.5 % and 55.9 % (P=0.059), respectively. The 1-year CIR was 6.25 % and 28.6 %, respectively. Univariate and multivariate Cox regression analyses showed that decitabine consolidation after CAR-T therapy was significantly associated with superior OS (hazard ratio [HR]: 0.121, 95 % confidence interval [CI]: 0.015-0.947, P=0.044), and bridging to haematopoietic stem cell transplantation after CAR-T therapy was significantly associated with superior LFS (HR: 0.279, 95 %CI: 0.093-0.840, P=0.023).
Our study recommends decitabine consolidation after CD19/CD22 CAR-T therapy as a novel maintenance strategy to improve the survival outcomes of patients with r/r B-ALL.
我们旨在评估 CD19/CD22 嵌合抗原受体 T 细胞（CAR-T）治疗后进行地西他滨巩固治疗对复发/难治性 B 细胞急性淋巴细胞白血病（r/r B-ALL）患者的疗效。
我们回顾性分析了 2017 年 9 月至 2021 年 5 月期间接受 CD19/CD22 CAR-T 治疗的 48 例 r/r B-ALL 患者。16 例患者在 CAR-T 治疗后接受地西他滨巩固治疗（20mg/m/天，每 3 个月 1 次，共 5 天）（DAC 组），而 32 例患者未接受地西他滨巩固治疗（CON 组）。在两组中评估总生存（OS）、无白血病生存（LFS）和累积复发率（CIR）。使用 Kaplan-Meier 方法进行时间事件分析。
DAC 组和 CON 组的中位随访期分别为 41.2 个月和 28.6 个月。两组的 4 年 OS 和 4 年 LFS 率分别为 93.3%和 64.3%（P=0.029）和 87.5%和 55.9%（P=0.059）。1 年 CIR 分别为 6.25%和 28.6%。单因素和多因素 Cox 回归分析显示，CAR-T 治疗后进行地西他滨巩固治疗与 OS 显著相关（风险比 [HR]：0.121，95%置信区间 [CI]：0.015-0.947，P=0.044），而 CAR-T 治疗后桥接造血干细胞移植与 LFS 显著相关（HR：0.279，95%CI：0.093-0.840，P=0.023）。
我们的研究建议在 CD19/CD22 CAR-T 治疗后进行地西他滨巩固治疗作为一种新的维持策略，以改善 r/r B-ALL 患者的生存结果。
