博纳吐单抗治疗急性B淋巴细胞白血病的回顾性研究

  目的  评估博纳吐单抗在急性B淋巴细胞白血病（B-cell acute lymphoblastic leukemia，B-ALL）患者治疗中的近期疗效和安全性。  方法  回顾性分析2021年8月至2022年4月于苏州大学附属第一医院及苏州弘慈血液病医院接受博纳吐单抗治疗的21例B-ALL患者的临床及随访资料。  结果  21例B-ALL患者，中位随访5.1（1.3～8.3）个月。11例复发/难治性（relapsed and refractory，R/R）患者中，45.5%获得完全缓解（complete response，CR）/CR伴血液学不完全恢复（CR with incomplete hematological recovery，CRi），其中80.0%达到微小残留病（minimal residual disease，MRD）阴性。3例CR/CRi且MRD阳性者全部出现MRD反应。14例MRD阳性患者中，5例桥接异基因造血干细胞移植，9例未移植，6个月总生存率（overall survival，OS）分别为100%和76.0%（P=0.260），2个月无白血病生存率（leukemia-free survival，LFS）分别为80.0%和33.0%（P=0.044）。既往化疗次数少于3次者较3次及以上者拥有更长久的LFS（P=0.001）。所有患者均出现任何等级的不良事件，仅1例出现3级细胞因子释放综合征，未出现致命性不良事件。  结论  博纳吐单抗在R/R和MRD阳性B-ALL患者中均获得较高的治疗反应率，早期应用有利于获得深层缓解后尽早桥接移植，延长无病生存期。 

Efficacy and safety of blinatumomab in the treatment of B-cell acute lymphoblastic leukemia: a retrospective study

  Objective  To evaluate the short-term efficacy and safety of blinatumomab in the treatment of patients with B-cell acute lymphoblastic leukemia (B-ALL).   Methods  Clinical and follow-up data for 21 patients with B-ALL who received blinatumomab from August 2021 to April 2022 at The First Affiliated Hospital of Soochow University and Soochow Hopes Hematonosis Hospital were retrospectively analyzed.   Results  All 21 patients were followed up regularly with a median follow-up time of 5.1 (1.3–8.3) months. Of the 11 patients with relapsed or refractory (R/R) B-ALL, the complete response (CR) or CR with incomplete hematological recovery (CRi) rate was 45.5% and the minimal residual disease (MRD)-negative rate among patients with a CR or a CRi was 80.0%. All three patients with a MRD-positive CR or CRi achieved MRD negativity. Of the 14 MRD-positive patients, five patients received allogeneic hematopoietic stem cell transplantation (allo-HSCT) after blinatumomab treatment, and nine patients did not. The 6-month overall survival rates of the allo-HCST and non-allo-HCST groups were 100.0% and 76.0% (P=0.260), and the 2-month leukemia-free survival (LFS) rates were 80.0% and 33.0% (P=0.044), respectively. In addition, patients who received less than three times of chemotherapy had longer LFS than those who received three or more times of chemotherapy (P=0.001). All the patients experienced adverse events of any grade. Only one patient experienced grade 3 of cytokine release syndrome, but no fatal adverse events occurred.   Conclusions  Blinatumomab achieved high treatment response rates in both R/R and MRD-positive B-ALL patients, which is conducive to early bridging transplantation after deep remission and prolonging leukemia free survival.