文章：

奥加伊妥珠单抗治疗复发/难治性急性淋巴细胞白血病：疾病负荷下的结局

Inotuzumab ozogamicin for relapsed/refractory acute lymphoblastic leukemia: outcomes by disease burden

原文发布日期：2020-08-07

DOI: 10.1038/s41408-020-00345-8

类型: Article

开放获取: 是

英文摘要：

Adults with relapsed/refractory acute lymphoblastic leukemia (R/R ALL) have a poor prognosis, especially if disease burden is high. This post hoc analysis of the phase 3 INO-VATE trial examined the efficacy and safety of inotuzumab ozogamicin (InO) vs. standard of care chemotherapy (SC) among R/R ALL patients with low, moderate, or high disease burden, respectively, defined as bone marrow blasts (BMB) < 50% (n = 53 vs. 48), 50–90% (n = 79 vs. 83), and >90% (n = 30 vs. 30). Patients in the InO vs. SC arm with low, moderate, and high BMB%, respectively, had improved rates of complete remission/complete remission with incomplete hematologic recovery (74% vs. 46% [p = 0.0022], 75 vs. 27% [p < 0.0001], and 70 vs. 17% [p < 0.0001]), and improved overall survival (hazard ratio: 0.64 [p = 0.0260], 0.81 [p = 0.1109], and 0.60 [p = 0.0335]). Irrespective of BMB%, cytopenias were the most common treatment-emergent adverse events, and post-transplant veno-occlusive disease was more common with InO vs. SC. Patients with extramedullary disease or lymphoblastic lymphoma showed similar efficacy and safety outcomes. This favorable benefit-to-risk ratio of InO treatment irrespective of disease burden supports its use in challenging and high disease burden subpopulations. INO-VATE is registered at www.clinicaltrials.gov: #NCT01564784.
 

摘要翻译： 

复发/难治性急性淋巴细胞白血病（R/R ALL）成人患者预后较差，尤其在疾病负荷较高时。本次对3期INO-VATE试验进行的事后分析，分别考察了inotuzumab ozogamicin（InO）对比标准护理化疗（SC）在低、中、高疾病负荷（定义为骨髓原始细胞比例分别为<50% [n=53 vs. 48]、50-90% [n=79 vs. 83] 及>90% [n=30 vs. 30]）的R/R ALL患者中的疗效与安全性。InO组相较于SC组，在低、中、高骨髓原始细胞比例患者中，完全缓解/伴血液学不完全恢复的完全缓解率均有所提升（分别为74% vs. 46% [p=0.0022]、75% vs. 27% [p<0.0001] 及70% vs. 17% [p<0.0001]），总生存期也得到改善（风险比分别为0.64 [p=0.0260]、0.81 [p=0.1109] 和0.60 [p=0.0335]）。无论骨髓原始细胞比例如何，血细胞减少均为最常见的治疗期间不良事件，而移植后静脉闭塞性疾病在InO组中较SC组更常见。伴有髓外病变或淋巴母细胞淋巴瘤的患者显示出相似的疗效和安全性结果。无论疾病负荷如何，InO治疗均表现出有利的获益-风险比，这支持其在具有挑战性及高疾病负荷亚群中的应用。INO-VATE试验已在www.clinicaltrials.gov注册，编号为#NCT01564784。

原文链接：

Inotuzumab ozogamicin for relapsed/refractory acute lymphoblastic leukemia: outcomes by disease burden