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的临床疗效和安全性
[Clinical efficacy and safety of blinatumomab bridging CAR-T cell therapy in the treatment of patients with adult acute B-cell lymphoblastic leukemia].
发表日期:2024 Apr 14
作者:
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
来源:
CYTOKINE & GROWTH FACTOR REVIEWS
摘要:
目的:探讨桥接博纳吐莫单抗(BiTE)联合嵌合抗原受体 T(CAR-T)细胞疗法治疗成人急性 B 细胞淋巴细胞白血病(B-ALL)的疗效和安全性。方法: 回顾性分析2018年8月至2023年5月苏州大学第一附属医院收治的36例成人B-ALL患者的临床资料。共纳入36例:男18例,女18例。中位年龄为 43.5 岁(21-72 岁)。此外,报告了21例费城染色体阳性急性淋巴细胞白血病,其中16例复发或难治。 18 名患者接受了 blinatumomab 桥接,随后接受 CAR-T 细胞治疗,18 名患者接受了 CAR-T 细胞治疗。本研究分析了两组患者治疗的有效性和安全性。结果:BiTE桥接CAR-T组中有16名患者在BiTE免疫治疗后达到完全缓解(CR),CR率为88.9%。桥接CAR-T治疗后1个月,骨髓检查CR率为100.0%,微小残留病(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治疗组(11.1% vs. 50.0%,Fisher,P=0.027)。随访显示,13例患者继续维持MRD阴性,5例患者在治疗后8.40个月(2.57-10.20个月)出现复发。五名复发患者中有两人在接受第二次 CAR-T 细胞治疗后达到 CR。在非桥接治疗组中,10 例患者维持持续 MRD 阴性,7 例复发,6 例死亡。 BiTE桥接CAR-T组的1年总生存率高于非桥接治疗组,差异在0.1水平上具有统计学意义(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 治疗中表现出优异的疗效,近期复发率较低,并且在随访期间持续评估长期疗效。
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.