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.
目的: 探讨含10天地西他滨预处理方案异基因造血干细胞移植(allo-HSCT)治疗急性髓系白血病(AML)/骨髓增生异常综合征(MDS)的早期疗效及安全性。 方法: 选择2021年4月至2022年5月间在中国医学科学院血液病医院接受含10天地西他滨(20 mg·m(-2)·d(-1),-13 d~-4 d)预处理方案allo-HSCT的31例AML/MDS患者,对其临床资料进行分析。 结果: ①31例患者中男16例,女15例,中位年龄41(20~55)岁;AML 10例,MDS转变AML(MDS-AML)6例,慢性粒-单核细胞白血病转变AML(CMML-AML)1例,MDS 14例。②31例(100%)患者均获得粒细胞植入和血小板植入,中位植入时间分别为12(9~30)d、14(9~42)d。③预处理期间16例(51.6%)患者发生口腔黏膜炎,其中Ⅰ/Ⅱ级15例(48.4%),Ⅲ级1例(3.2%);移植后13例(41.9%)患者发生巨细胞病毒血症,6例(19.4%)患者发生出血性膀胱炎,4例(12.9%)患者发生局部感染。④急性移植物抗宿主病(GVHD)中位发生时间为移植后33(12~111)d,移植后100 d急性GVHD累积发生率为41.9%(95%CI 26.9%~61.0%),Ⅲ/Ⅳ级急性GVHD累积发生率为22.9%(95%CI 13.5%~47.7%);轻、中度慢性GVHD累积发生率为23.5%(95%CI 12.1%~43.6%),未发生重度慢性GVHD。⑤1例患者死于复发,未发生非复发死亡;移植后1年累积复发率为3.2%(95%CI 0.5%~20.7%);移植后1年总生存率、无病生存率分别为92.9%(95%CI 80.3%~100.0%)、96.8%(95%CI 90.8%~100.0%)。 结论: 含10天地西他滨预处理方案allo-HSCT治疗AML/MDS可获得较好的早期疗效且安全性良好。.
Keywords: 10-day decitabine; Acute myeloid leukemia; Allogeneic hematopoietic stem cell transplantation; Conditioning regimen; Myelodysplastic syndrome.