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以韩国血液学会 ALL 工作组代表的身份,评估blinatumomab 治疗复发/难治性成人急性淋巴细胞白血病的疗效和安全性。

Efficacy and safety of blinatumomab treatment in adult Korean patients with relapsed/refractory acute lymphoblastic leukemia on behalf of the Korean Society of Hematology ALL Working Party.

机构信息

Chonnam National University Hwasun Hospital, Hwasun, Republic of Korea.

Korea University Ansan Hospital, Ansan, Republic of Korea.

出版信息

Ann Hematol. 2019 Jan;98(1):151-158. doi: 10.1007/s00277-018-3495-2. Epub 2018 Sep 26.

DOI:10.1007/s00277-018-3495-2
PMID:30259121
Abstract

Blinatumomab, a bispecific T cell-engaging antibody, has demonstrated efficacy for relapsed or refractory acute lymphoblastic leukemia (ALL). In this study, we evaluated the efficacy and toxicity of blinatumomab in adult Korean patients with relapsed or refractory Philadelphia-negative B cell precursor ALL. A total of 50 patients received blinatumomab treatment between June 2016 and August 2017 in Korea. The median number of prior therapy was one (range, 1-4). Among the 49 evaluable patients, 22 (44.9%) achieved complete response (CR) or CR with incomplete blood count recovery, and 16 of whom subsequently underwent allogenic stem cell transplantation. Although no statistically significant differences were observed, patients with extramedullary disease and poor performance status had lower responses to blinatumomab treatment. In addition, the use of high-dose dexamethasone prior to blinatumomab treatment did not affect the response to blinatumomab. The median event-free survival and overall survival of the responders were 7.5 and 8.1 months, respectively. For non-hematologic toxicities, the most common toxicity was infection. The incidences of severe cytokine release syndrome and neurologic toxicity each was 4%. In conclusion, blinatumomab was an effective and tolerable therapy in adult Korean patients with relapsed or refractory Philadelphia-negative B cell precursor ALL.

摘要

blinatumomab 是一种双特异性 T 细胞结合抗体,已被证明对复发性或难治性急性淋巴细胞白血病(ALL)有效。在这项研究中,我们评估了 blinatumomab 在韩国复发或难治性费城染色体阴性 B 细胞前体 ALL 成人患者中的疗效和毒性。2016 年 6 月至 2017 年 8 月期间,共有 50 名患者在韩国接受了 blinatumomab 治疗。先前治疗的中位数为 1 次(范围,1-4 次)。在 49 名可评估患者中,22 名(44.9%)达到完全缓解(CR)或不完全血细胞计数恢复的 CR,其中 16 名随后接受了同种异体干细胞移植。尽管没有观察到统计学上的显著差异,但有髓外疾病和较差表现状态的患者对 blinatumomab 治疗的反应较低。此外,在使用 blinatumomab 治疗前使用高剂量地塞米松不会影响对 blinatumomab 的反应。应答者的中位无事件生存和总生存时间分别为 7.5 个月和 8.1 个月。对于非血液学毒性,最常见的毒性是感染。严重细胞因子释放综合征和神经毒性的发生率分别为 4%。总之,blinatumomab 是一种在韩国复发或难治性费城染色体阴性 B 细胞前体 ALL 成人患者中有效且耐受良好的治疗方法。

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