Department of Medicine A - Hematology, Hemostaseology, Oncology, Pulmonology, University Hospital Münster, Münster, Germany.
Department of Medicine A - Hematology, Hemostaseology, Oncology, Pulmonology, University Hospital Münster, Münster, Germany.
Clin Lymphoma Myeloma Leuk. 2020 Oct;20(10):e724-e733. doi: 10.1016/j.clml.2020.05.022. Epub 2020 Jun 3.
Blinatumomab and inotuzumab ozogamicin are now widely used to treat relapsed or refractory B-cell acute lymphoblastic leukemia (r/r B-ALL).
We have reported the clinical course of 34 adult patients with r/r B-ALL receiving blinatumomab or inotuzumab ozogamicin at our institution from 2009 to 2019.
Blinatumomab-based salvage therapy was applied for overt r/r B-ALL (n = 13) or minimal residual disease (MRD) positivity (n = 5). Of the 13 patients with r/r B-ALL, 9 (69%; 95% confidence interval [CI], 39%-91%) achieved complete remission (CR), with 78% of CR patients (95% CI, 40%-97%) reaching MRD negativity. MRD negativity was also achieved in all 5 patients treated for MRD positivity. The 1-year overall survival of patients receiving blinatumomab for r/r B-ALL and MRD positivity was 54% (n = 13; 95% CI, 26%-81%) and 80% (n = 5; 95% CI, 44-100), respectively. In the inotuzumab ozogamicin group, all 16 patients were treated for overt r/r B-ALL. The rate of CR was 94% (95% CI, 70%-100%), with 67% (95% CI, 38%-88%) of CR patients reaching MRD negativity. The 1-year OS after the first application of inotuzumab ozogamicin was 46% (95% CI, 18%-74%). Of those patients receiving blinatumomab and inotuzumab ozogamicin as a bridge-to-transplant strategy, 79% and 80%, respectively, proceeded to allogeneic stem cell transplantation. The most frequent drug-specific adverse events were similar to those previously reported, including cytokine release syndrome, capillary leak syndrome, and neurotoxicity for blinatumomab and transplant-associated veno-occlusive disease of the liver for inotuzumab ozogamicin.
Together with previous observations from phase III clinical trials, these data suggest that blinatumomab and inotuzumab ozogamicin are highly effective salvage regimens in r/r B-ALL.
blinatumomab 和 inotuzumab ozogamicin 现已广泛用于治疗复发/难治性 B 细胞急性淋巴细胞白血病（r/r B-ALL）。
我们报道了 2009 年至 2019 年期间在我院接受 blinatumomab 或 inotuzumab ozogamicin 治疗的 34 例 r/r B-ALL 成年患者的临床经过。
blinatumomab 为基础的挽救治疗应用于明显 r/r B-ALL（n=13）或微小残留病（MRD）阳性（n=5）。在 13 例 r/r B-ALL 患者中，9 例（69%；95%置信区间[CI]，39%-91%）获得完全缓解（CR），78%的 CR 患者（95%CI，40%-97%）达到 MRD 阴性。5 例接受 MRD 阳性治疗的患者也达到了 MRD 阴性。接受 blinatumomab 治疗 r/r B-ALL 和 MRD 阳性的患者 1 年总生存率分别为 54%（n=13；95%CI，26%-81%）和 80%（n=5；95%CI，44%-100%）。在 inotuzumab ozogamicin 组中，所有 16 例患者均接受明显 r/r B-ALL 治疗。CR 率为 94%（95%CI，70%-100%），67%（95%CI，38%-88%）的 CR 患者达到 MRD 阴性。首次应用 inotuzumab ozogamicin 后 1 年 OS 为 46%（95%CI，18%-74%）。接受 blinatumomab 和 inotuzumab ozogamicin 桥接移植策略的患者中，分别有 79%和 80%进行了异基因造血干细胞移植。最常见的药物特异性不良事件与以前报道的相似，包括细胞因子释放综合征、毛细血管渗漏综合征和神经毒性（blinatumomab），以及肝静脉闭塞性疾病（inotuzumab ozogamicin）。
与以前的 III 期临床试验结果一起，这些数据表明 blinatumomab 和 inotuzumab ozogamicin 在 r/r B-ALL 中是高度有效的挽救方案。
