[blinatumomab桥接CAR-T细胞疗法治疗成人急性B细胞淋巴细胞白血病患者的临床疗效和安全性]。

Q3 Medicine
Y Pu, X Y Zhou, Y Liu, X Kong, J J Han, J Zhang, Z H Lin, J Chen, H Y Qiu, D P Wu
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引用次数: 0

摘要

研究目的探索桥接blinatumomab(BiTE)联合嵌合抗原受体T(CAR-T)细胞疗法治疗急性B细胞淋巴细胞白血病(B-ALL)成人患者的有效性和安全性。方法:回顾性分析2018年8月至2023年5月在苏州大学附属第一医院接受治疗的36例成人B-ALL患者的临床数据。共纳入 36 例患者:男性 18 例,女性 18 例。中位年龄为43.5岁(21-72岁)。此外,还报告了21例费城染色体阳性急性淋巴细胞白血病病例,其中16例为复发或难治性病例。18例患者接受了blinatumomab桥接疗法,随后接受了CAR-T细胞疗法,18例患者接受了CAR-T细胞疗法。本研究分析了两组患者的疗效和安全性。研究结果在BiTE桥接至CAR-T组中,16名患者在接受BiTE免疫疗法后获得了完全缓解(CR),CR率为88.9%。桥接 CAR-T 治疗一个月后,骨髓检查显示 CR 率为 100.0%,最小残留病(MRD)阴性率高于非桥接治疗组(94.4% vs. 61.1%,Fisher,P=0.041)。BiTE桥接至CAR-T组细胞因子释放综合征和其他不良反应的发生率低于非桥接疗法组(11.1% vs. 50.0%,Fisher,P=0.027)。随访显示,13 名患者继续保持 MRD 阴性,5 名患者在治疗后 8.40 个月(2.57-10.20 个月)复发。5名复发患者中有2名在接受第二次CAR-T细胞治疗后达到了CR。在非桥接疗法组中,10 名患者保持持续 MRD 阴性,7 名患者复发,6 名患者死亡。BiTE桥接至CAR-T组的1年总生存率高于非桥接治疗组,在0.1水平上差异有统计学意义(88.9%±10.5% vs. 66.7%±10.9%,P=0.091)。结论BiTE桥接CAR-T细胞疗法在成人B-ALL治疗中表现出卓越的疗效,近期复发率较低,并且在随访过程中还将对长期疗效进行评估。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
[Clinical efficacy and safety of blinatumomab bridging CAR-T cell therapy in the treatment of patients with adult acute B-cell lymphoblastic leukemia].

Objective: Exploring the efficacy and safety of bridging blinatumomab (BiTE) in combination with chimeric antigen receptor T (CAR-T) cell therapy for the treatment of adult patients with acute B-cell lymphoblastic leukemia (B-ALL) . Methods: Clinical data from 36 adult B-ALL patients treated at the First Affiliated Hospital of Suzhou University from August 2018 to May 2023 were retrospectively analyzed. A total of 36 cases were included: 18 men and 18 women. The median age was 43.5 years (21-72 years). Moreover, 21 cases of Philadelphia chromosome-positive acute lymphoblastic leukemia were reported, and 16 of these cases were relapsed or refractory. Eighteen patients underwent blinatumomab bridging followed by CAR-T cell therapy, and 18 patients received CAR-T cell therapy. This study analyzed the efficacy and safety of treatment in two groups of patients. Results: In the BiTE bridge-to-CAR-T group, 16 patients achieved complete remission (CR) after BiTE immunotherapy, with a CR rate of 88.9%. One month after bridging CAR-T therapy, bone marrow examination showed a CR rate of 100.0%, and the minimal residual disease (MRD) negativity rate was higher than the nonbridging therapy group (94.4% vs. 61.1%, Fisher, P=0.041). The incidence of cytokine release syndrome and other adverse reactions in the BiTE bridge-to-CAR-T group was lower than that in the nonbridging therapy group (11.1% vs. 50.0%, Fisher, P=0.027). The follow-up reveals that 13 patients continued to maintain MRD negativity, and five patients experienced relapse 8.40 months (2.57-10.20 months) after treatment. Two of five patients with relapse achieved CR after receiving the second CAR-T cell therapy. In the nonbridging therapy group, 10 patients maintained continuous MRD negativity, 7 experienced relapse, and 6 died. The 1 year overall survival rate in the BiTE bridge-to-CAR-T group was higher than that in the nonbridging therapy group, with a statistically significant difference at the 0.1 level (88.9%±10.5% vs. 66.7%±10.9%, P=0.091) . Conclusion: BiTE bridging CAR-T cell therapy demonstrates excellent efficacy in adult B-ALL treatment, with a low recent recurrence rate and ongoing assessment of long-term efficacy during follow-up.

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