研究动态
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[十天去甲基化脱氧胆碱含量制备的配制方案对于31名急性髓系白血病/骨髓增殖异常综合征患者的异基因造血干细胞移植的效果和安全性]

[Effect and safety of 10-day decitabine-containing conditioning regimen for allogeneic hematopoietic stem cell transplantation in 31 patients with acute myeloid leukemia/myelodysplastic syndrome].

发表日期:2023 Jun 14
作者: J Liu, Y G Cao, R L Zhang, W H Zhai, X Chen, Q L Ma, A M Pang, D L Yang, J L Wei, Y He, S Z Feng, M Z Han, E L Jiang
来源: Experimental Hematology & Oncology

摘要:

目的:探究含有10天地西他滨的异基因造血干细胞移植(allo-HSCT)在急性髓系白血病(AML)/骨髓增生异常综合征(MDS)治疗中的早期效果和安全性。方法:纳入2021年4月至2022年5月期间接受含有10天地西他滨的allo-HSCT治疗的31例AML/MDS患者进行分析。结果:共31例患者,其中AML(n=10),MDS-AML(n=6),CMML-AML(n=1)和MDS(n=14)。男性16例,女性15例,年龄中位数为41岁(20-55岁)。31例患者(100%)成功植入中性粒细胞和血小板,中位植入持续时间分别为12天(9-30天)和14天(9-42天)。预处理期间,有16例(51.6%)患者出现口腔黏膜炎,其中Ⅰ/Ⅱ级15例(48.4%),Ⅲ级1例(3.2%)。移植后,13例患者(41.9%)出现CMV病毒血症,6例患者(19.4%)出现出血性膀胱炎,4例患者(12.9%)出现局部感染。移植后急性移植物抗宿主病(aGVHD)的中位时间为33天(12-111天)。aGVHD和Ⅲ/Ⅳ级aGVHD的累积发生率分别为41.9%(95% CI 26.9%-61.0%)和22.9%(95% CI 13.5%-47.5%)。无严重的慢性移植物抗宿主病(cGVHD),轻度和中度cGVHD发生率为23.5%(95% CI 12.1%-43.6%)。截至2022年11月30日,31例患者中仅有1例复发,1年累积复发率(CIR)为3.2%(95% CI 0.5%-20.7%)。仅有1例复发患者死亡,无无复发死亡。1年总生存率(OS)和无病生存率(DFS)分别为92.9%(95% CI 80.3%-100%)和96.8%(95% CI 90.8%-100%)。结论:注入含有10天地西他滨的预处理方案的allo-HSCT可以降低复发率,并且在AML/MDS治疗中是安全可行的。
Objective: To investigate the early effect and safety of allogeneic hematopoietic stem cell transplantation (allo-HSCT) with a 10-day decitabine-containing conditioning regimen in the treatment of acute myeloid leukemia (AML) /myelodysplastic syndrome (MDS) . Methods: From April 2021 to May 2022, 31 AML/MDS patients who received allo-HSCT with a 10-day decitabine-containing conditioning regimen were analyzed. Results: AML (n=10), MDS-AML (n=6), CMML-AML (n=1), and MDS (n=14) were identified in 31 patients, 16 males, and 15 females, with a median age of 41 (20-55) yr. Neutrophils and platelets were successfully implanted in 31 patients (100%), with a median implantation duration of 12 (9-30) and 14 (9-42) days, respectively. During the preconditioning period, 16 patients (51.6%) developed oral mucositis, with 15 cases of Ⅰ/Ⅱ grade (48.4%) and one case of Ⅲ grade (3.2%). After transplantation, 13 patients (41.9%) developed CMV viremia, six patients (19.4%) developed hemorrhagic cystitis, and four patients (12.9%) developed a local infection. The median time of acute graft versus host disease (aGVHD) following transplantation was 33 (12-111) days. The cumulative incidence of aGVHD and Ⅲ/Ⅳ grade aGVHD was 41.9% (95% CI 26.9%-61.0%) and 22.9% (95% CI 13.5%-47.5%), respectively. There was no severe cGVHD, and mild and moderate chronic GVHD (cGVHD) incidence was 23.5% (95% CI 12.1%-43.6%). As of November 30, 2022, only one of the 31 patients had relapsed, with a 1-yr cumulative relapse rate (CIR) of 3.2% (95% CI 0.5%-20.7%). There was only one relapse patient death and no non-relapse deaths. The 1-yr overall survival (OS) and disease-free survival (DFS) rates were 92.9% (95% CI 80.3%-100%) and 96.8% (95% CI 90.8%-100%), respectively. Conclusions: A 10-day decitabine-containing conditioning regimen for allo-HSCT reduced relapse and was safe and feasible in treating AML/MDS.