Improved survival for young acute leukemia patients following a new donor hierarchy for allogeneic hematopoietic stem cell transplantation: A phase III randomized controlled study

Improved survival for young acute leukemia patients following a new donor hierarchy for allogeneic hematopoietic stem cell transplantation: A phase III randomized controlled study
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采用新的同种异体造血干细胞移植供者等级后,年轻急性白血病患者的生存率得到改善:一项 III 期随机对照研究

DOI:
10.1002/ajh.26317
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发表时间:
2021
影响因子:
12.8
通讯作者:
He Huang
He Huang
中科院分区:
医学1区
文献类型:
--
作者:
Mingming Zhang;Haowen Xiao;Jimin Shi;Yamin Tan;Yanmin Zhao;Jian Yu;Xiaoyu Lai;Yongxian Hu;Weiyan Zheng;Yi Luo;He Huang

文献摘要

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本研究的目的是评价年轻急性白血病(AL)患者进行异基因造血干细胞移植(allo-HSCT)的最佳供者方案,包括人类白细胞抗原相合的同胞供者(MSD)、非亲缘供者(URD)、单倍体相合的双亲供者(HPDs)和半相合的同胞供者(HSD)。从2008年3月至2016年12月,430例35岁≤ 的AL患者被纳入这项发现,回顾研究。与接受URD或HPD移植的患者相比,接受MSD或HSD移植的患者的5年OS率更高。接受HSD-HSCT的高危患者的移植物抗白血病效果优于接受HSD-HSCT的患者,与接受MSD-HSCT的患者相比,复发率较低(p=0.014),无病生存率(DFS)较高(p=0.029)。接受URD或HPD的高危患者的结果是相同的。对于中等/标准风险患者,MSD或HSD可能是具有类似结果的一线供者选择。与HPD相比,HL A相合的无血缘关系的供者更受欢迎,无复发死亡率更低,总存活率(OS)和无病生存率(DFS)更高。我们进一步进行了一项独立的前瞻性随机研究,以评估使用新的供体等级的生存优势。250名患者被随机分配到我们的新的供体等级或传统的供体等级,比例为2:1。新的捐赠者等级有助于显著提高2年OS和DFS率(OS:76.2%比67.8%,p=0.046;DFS:71.8%比64.5%,p=0.039)。
The aim of our study was to evaluate the most optimal donor for young acute leukemia (AL) patients with multiple donors available for allogeneic hematopoietic stem cell transplantation (allo‐HSCT), including HLA‐matched sibling donors (MSDs), HLA‐matched unrelated donors (URDs), haploidentical parental donors (HPDs), and haploidentical sibling donors (HSDs). From March 2008 to December 2016, 430 AL patients ≤ 35 years of age were included in the discovery, retrospective study. Patients who received transplantation from a MSD or a HSD had better 5‐year OS rates compared with patients who received transplantation from a URD or a HPD. A superior graft‐versus‐leukemia effect was observed for high‐risk patients undergoing HSD‐HSCT with a lower relapse rate (p= 0.014) and a higher disease‐free survival (DFS) rate (p= 0.029) compared with those undergoing MSD‐HSCT. Outcomes of high‐risk patients receiving an URD or HPD were equivalent. For intermediate/standard‐risk patients, either a MSD or HSD may be the front‐line donor selection with comparable outcomes. HLA‐matched unrelated donors were preferred over HPDs with reduced non‐relapse mortality and higher overall survival (OS) and DFS rates. We further conducted an independent prospective randomized study to evaluate the survival advantage with the new donor hierarchy. Two hundred and fifty patients were randomly assigned to follow our new donor hierarchy or the traditional donor hierarchy at a 2:1 ratio. The new donor hierarchy contributed to significantly superior 2‐year OS and DFS rates (OS: 76.2% vs. 67.8%,p= 0.046; DFS: 71.8% vs. 64.5%,p= 0.039).