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Role of antithymocyte globulin in matched sibling donor peripheral blood stem cell transplantation for hematologic malignancies

机译:Antrithymocyte球蛋白在血液学恶性肿瘤中匹配的兄弟供体外周血干细胞移植中的作用

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BACKGROUND:High incidence of chronic graft-versus-host disease (GVHD) has been a major drawback of matched sibling donor peripheral blood stem cell transplantation (MSD -PBSCT). This study aimed to investigate the safety and efficacy of antithymocyte globulin (ATG) as a standardized part of GVHD prophylaxis in patients receiving MSD -PBSCT.METHODS:A total of 72 patients with hematological malignancies receiving MSD -PBSCT who displayed similar baseline characteristics were either given rabbit ATG ( n?=?42) or no ATG (n?=?30), in addition to cyclosporine, methotrexate, and mycophenolate mofetil as a standard GVHD prophylaxis regimen. Either patients or donors aged ≥40?years were included in the study. Thymoglobulin was administered at a daily dose of 1.5?mg/kg on day -5 and 3.5?mg/kg on day -4 prior to transplant (the total dose was 5?mg/kg).RESULTS:After a median follow-up of 874?days, the 3-year cumulative incidence of chronic GVHD (cGVHD) was 37.3% in the ATG group and 52.1% in the non -ATG group. The 3-year overall and disease-free survival probability were 71.0% and 62.0% (ATG versus non -ATG, P?=?.262) and 66.7% and 58.4% (ATG versus non -ATG, P?=?.334). No difference was found in the 2-year cumulative incidence of nonrelapse mortality and relapse between the ATG and non -ATG groups. This significant reduction in the incidence of cGVHD without increased relapse risk and nonrelapse mortality led to a 3-year GVHD-free, relapse-free survival probability of 66.7% and 40.0% in the ATG and non-ATG groups, respectively.CONCLUSIONS:These data suggested that rabbit antithymocyte globulin in the current protocol for GVHD prophylaxis was well tolerable and efficacious.The clinical trial was registered on January 1, 2016 (ClinicalTrials.gov Identifier NCT02677181). https://clinicaltrials.gov/ct2/show/NCT02677181.Copyright ? 2021 the Author(s). Published by Wolters Kluwer Health, Inc.
机译:背景:慢性接枝腹膜疾病的高发病率(GVHD)是匹配的兄弟供体外周血干细胞移植(MSD -PBSCT)的主要缺点。本研究旨在探讨Antrithymocyte球蛋白(ATG)作为GVHD预防患者的标准化部分的安全性和有效性,接受MSD -PBSCT.methods:共有72例血液学恶性肿瘤患者接受MSD -PBSCT展示了类似的基线特征除了环孢菌素,甲氨蝶呤和霉酚酸酯Mofetil之外,给予兔ATG(n?=α42)或没有ATG(n?=β30),作为标准的GVHD预防植物方案。 ≥40岁的患者或捐赠者都被列入该研究。在移植前第5天和第3.5天和3.5天/ kg的每日剂量为1.5×5℃/ kg施用胸膜糊动蛋白(总剂量为5μm/ kg)。结果:后续后续后续行动后874岁的时间,慢性GVHD(CGVHD)的3年累积发生率为ATG组为37.3%,非-ATG组中的52.1%。 3年的总体和无病生存概率为71.0%和62.0%(ATG与非-ANG,P?=β.262)和66.7%和58.4%(ATG与非-ANG,P?= 334 )。在非筛选死亡率的2年累积发病率和ATG和非-ATG组之间复发中没有差异。这种显着降低了CGVHD的发生率而不会增加复发风险和非筛分死亡率导致了3年的GVHD,无复发的存活概率分别为ATG和非ATG组的66.7%和40.0%。结论:这些数据表明,目前GVHD预防的当前方案中的兔抗腹细胞球蛋白是良好的耐受性和有效的。临床试验于2016年1月1日注册(ClinicalTrials.gov标识符NCT02677181)。 https://clinicaltrials.gov/ct2/show/nct02677181.copyright? 2021提交人。由Wolters Kluwer Health,Inc。出版

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