贝林妥欧单抗与CD19 CAR-T细胞治疗急性B淋巴细胞白血病的安全性和短期疗效比较分析  

Comparative Analysis of Safety and Short-term Efficacy of Blinatumomab Versus Anti-CD19 CAR-T Cell Therapy in the Treatment of Acute B Lymphoblastic Leukemia

作　　者：徐慧[1] 张全诚 许倩文 薛磊 王兴兵 XU Hui;ZHANG Quancheng;XU Qianwen;XUE Lei;WANG Xingbing(Department of Hematology,First Affiliated Hospital of USTC(Anhui Provincial Hospital),HeFei 230001)

机构地区：[1]中国科学技术大学附属第一医院(安徽省立医院)血液科,安徽合肥230001

出　　处：《临床输血与检验》2025年第2期224-233,共10页Journal of Clinical Transfusion and Laboratory Medicine

基　　金：国家自然科学基金项目(No.82170221);安徽医科大学领先医学与先进技术研究中心项目(No.2023IHM01010);安徽省重点研发计划项目(No.2022e07020022)资助。

摘　　要：目的本文回顾性分析了我院接受贝林妥欧单抗和CD19 CAR-T细胞治疗急性B淋巴细胞白血病(B-ALL)患者的安全性、有效性及短期预后,并识别在不同基线特征的患者群体中两组之间的疗效差异。方法本研究共纳入2021—2023年接受贝林妥欧单抗治疗的21例患者和2016—2020年接受CD19 CAR-T细胞治疗的80例患者,先评估两组患者临床疗效,再通过亚组分析,在不同基线特征的患者中进行安全性、疗效和短期随访的比较,最后比较两种治疗后桥接移植对患者预后的影响。结果在贝林妥欧单抗组中,52.4%(11/21)的患者出现了细胞因子释放综合征(CRS),但无重度CRS及神经毒性发生,90.5%达到了微小残留病(MRD)阴性疾病缓解(CR)。相比之下,CAR-T组中有95.5%(64/67)的患者出现CRS,其中38.9%(26/67)为严重病例,86.7%实现了MRD阴性CR。根据亚组分析结果显示,不论治疗前肿瘤负荷或复发次数,贝林妥欧单抗组CRS反应较轻(P<0.05),并且两组疗效相当。贝林妥欧单抗组的中位无进展生存期(PFS)和总生存期(OS)尚未达到,12个月的PFS和OS率分别为70.7%和88.1%。CAR-T组的中位PFS和OS分别为12.3个月和19.0个月,12个月的PFS和OS率分别为52.0%和62.4%。接受治疗后脐带血移植(UCBT)的患者PFS显著改善(贝林妥欧单抗组P=0.010,CAR-T组P<0.001)。结论在不同肿瘤负荷和复发次数的B-ALL患者中,贝林妥欧单抗疗效与CD19 CAR-T细胞治疗相当,而CRS反应较低。治疗后进行脐带血移植显著提高了患者的生存率。但由于贝林妥欧单抗组的样本量和随访时间有限,需进一步扩大临床研究以确认长期疗效。Objective This retrospective study is to compare the safety,efficacy and short-term outcomes between blinatumomab and anti-CD19 CAR-T cell therapy in B-ALL patients treated at our institution.Methods The cohort included 21 patients treated with blinatumomab(2021—2023)and 80 patients treated with anti-CD19 CAR-T cells(2016—2020).Results In blinatumomab group,52.4%(11/21)of patients experienced cytokine release syndrome(CRS),with no severe CRS or neurotoxicity reported,and 90.5%achieved MRD-negative complete remission(CR).In contrast,95.5%(64/67)of patients in the CAR-T group experienced CRS,with 38.9%(26/67)classified as severe cases,and 86.7%achieved MRD-negative CR.Based on the results of the subgroup analysis,blinatumomab was associated with milder CRS compared to CAR-T therapy,regardless of pre-treatment tumor burden or relapse status(P<0.05).The efficacy between the two groups was comparable.The median progression-free survival(PFS)and overall survival(OS)were not reached in the blinatumomab group,with 12-month PFS and OS rates of 70.7%and 88.1%,respectively.In the CAR-T group,the median PFS and OS were 12.3 months and 19.0 months,with 12-month rates of 52.0%and 62.4%.Patients who underwent umbilical cord blood transplantation(UCBT)post-treatment had significantly improved PFS(P=0.010 for blinatumomab,P<0.001 for CAR-T).Conclusion In patients with B-ALL across varying tumor burdens and relapse counts,the efficacy of blinatumomab was comparable to that of CD19 CAR-T cell therapy,with a notably lower incidence of cytokine release syndrome(CRS).Post-treatment UCBT significantly enhanced patient survival.However,due to limited sample size and follow-up duration for the blinatumomab group,further research is needed to confirm the long-term efficacy.

关 键 词：CD19 CAR-T细胞治疗 贝林妥欧单抗 急性B淋巴细胞白血病 造血干细胞移植 

分 类 号：R733.71[医药卫生—肿瘤] R979.1[医药卫生—临床医学]