Hematology Department, Shamir (Asaf Harofe) Medical Center, Zerifin, Israel.
Department of Hematology and Bone Marrow transplantation, Rambam Health Care Campus, Haifa, Israel.
Ann Hematol. 2020 Apr;99(4):835-838. doi: 10.1007/s00277-019-03854-0. Epub 2020 Feb 20.
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.
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）的生存率有所提高，但复发/难治性疾病的结果仍不佳。blinatumomab 是一种针对 CD19/CD3 的双特异性单克隆抗体，对复发/难治性 B-ALL 以及微小残留病（MRD）阳性患者具有临床活性。我们报告了 blinatumomab 在复发/难治性 B-ALL 患者中的“真实世界”经验。
纳入 21 例中位年龄为 52 岁、中位疾病持续时间为 10 个月的患者。治疗指征为血液学复发（n=17）、MRD 阳性（n=2）、无法继续强化化疗（n=1）和桥接至第二次异体造血干细胞移植（alloSCT）（n=1）。blinatumomab 作为一线挽救治疗在 11 例患者中应用，在 8 例患者中作为一线挽救治疗后再次应用。
基线时获得完全缓解（CR）的患者中有 47%新获得 CR，75%的患者维持 CR。中位随访 12.4 个月时，13 例患者存活，11 例患者处于 CR。无白血病生存中位时间为 8.7 个月，总生存中位时间为 15.2 个月。与未接受干细胞移植的患者相比，进展至 alloSCT 的患者无白血病生存和总生存的中位时间分别为未达到和分别为 5.1 个月和 15.2 个月。
治疗耐受性良好，两名患者（10%）出现神经事件，三名患者（14%）出现胃肠道事件。四名患者（19%）报告细胞因子风暴。
总之，blinatumomab 在临床试验以外的环境中治疗成人复发/难治性 B-ALL 是有效且可耐受的。
