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Safety and efficacy of blinatumomab: a real world data.
Annals of Hematology ( IF 3.5 ) Pub Date : 2020-02-20 , DOI: 10.1007/s00277-019-03854-0
Arie Apel 1 , Yishai Ofran 2 , Ofir Wolach 3 , Shai Shimony 3 , Ron Ram 4 , Itai Levi 5 , Miri Zektser 6 , Maya Koren-Michowitz 1, 7
Affiliation  

Despite improvement in survival of newly diagnosed adult precursor B-acute lymphoblastic leukemia/lymphoma (B-ALL), the results of relapsed/refractory disease are poor. Blinatumomab, a bispecific monoclonal antibody directed against CD19/CD3 show clinical activity against relapsed/refractory B-ALL and in minimal residual disease (MRD)-positive patients.We report our "real-world" experience with blinatumomab in patients with relapsed/refractory B-ALL.Twenty-one patients, at a median age 52 years with median disease duration of 10 months, were included. Indications for treatment were hematological relapse (n = 17), MRD positivity (n = 2), inability to continue intensive chemotherapy (n = 1), and bridging to a second alloSCT (n = 1). Blinatumomab was given as first salvage in 11 patients and after at least one prior salvage treatment in eight.Complete response (CR) was newly achieved in 47% and was maintained in 75% of patients with baseline CR. At a median follow-up of 12.4 months, 13 patients were alive, and 11 in CR. Median leukemia-free survival was 8.7 months, and median overall survival was 15.2 months. Median leukemia-free survival and overall survival were not reached in patients proceeding to alloSCT compared to 5.1 and 15.2 months, respectively, for patients who did not receive stem cell transplantation.Treatment was well tolerated with neurological events reported in two patients (10%) and GI events in three patients (14%). Cytokine storm was reported in four patients (19%).In conclusion, treatment with blinatumomab is effective and tolerable in adult patients with relapsed/refractory B-ALL outside of a clinical trial stetting.

中文翻译:

blinatumomab的安全性和有效性:真实数据。

尽管新诊断的成人前体B急性淋巴细胞白血病/淋巴瘤(B-ALL)的存活率有所提高,但复发/难治性疾病的结果却很差。Blinatumomab是一种针对CD19 / CD3的双特异性单克隆抗体,在复发/难治性B-ALL和最小残留疾病(MRD)阳性患者中均表现出临床活性。 B-ALL。包括21位患者,中位年龄52岁,中位疾病持续时间10个月。治疗的指征是血液学复发(n = 17),MRD阳性(n = 2),无法继续进行强化化疗(n = 1)和桥接第二次alloSCT(n = 1)。首次接受Blinatumomab治疗的是11例患者,至少接受过一次补救治疗的是8例。在基线CR的患者中,新的完全缓解(CR)达到47%,并且维持在75%。中位随访时间为12.4个月,有13例患者存活,其中11例为CR。无白血病中位生存期为8.7个月,中位总生存期为15.2个月。进行alloSCT的患者未达到中位无白血病生存期和总生存期,而未接受干细胞移植的患者分别达到5.1和15.2个月。两名患者报告的神经系统事件对治疗的耐受性良好(10%)和三名患者的胃肠道事件(14%)。据报道有4位患者发生了细胞因子风暴(19%)。
更新日期:2020-02-20
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