Effect of rhG-CSF Combined With Decitabine Prophylaxis on Relapse of Patients With High-Risk MRD-Negative AML After HSCT: An Open-Label, Multicenter, Randomized Controlled Trial.
Effect of rhG-CSF Combined With Decitabine Prophylaxis on Relapse of Patients With High-Risk MRD-Negative AML After HSCT: An Open-Label, Multicenter, Randomized Controlled Trial.
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rhG-CSF联合地西他滨预防对HSCT后高危MRD阴性AML患者复发的影响：一项开放标签、多中心、随机对照试验
DOI：
10.1200/jco.19.03277
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发表时间：
2020-12-20
期刊：
影响因子：
--
通讯作者：
Zhang X
中科院分区：
文献类型：
--
作者：
Gao L;Zhang Y;Wang S;Kong P;Su Y;Hu J;Jiang M;Bai H;Lang T;Wang J;Liu L;Yang T;Huang X;Liu F;Lou S;Liu Y;Zhang C;Liu H;Gao L;Liu J;Zhu L;Wen Q;Chen T;Wang P;Rao J;Mao M;Wang C;Duan X;Luo L;Peng X;Cassady K;Zhong JF;Zhang X
目的复发是高危急性髓系白血病(HR-AML)异基因造血干细胞移植(allo-HSCT)治疗失败的主要原因。本研究旨在探讨重组人粒细胞集落刺激因子(rhG-CSF)联合小剂量地西他滨(DEC)预防allo-HSCT后HR-AML复发的作用。患者和方法我们进行了II期、开放标签、多中心、随机对照试验。将204例在随机前60~100天接受allo-HSCT治疗的微小残留病阴性的HR-AML患者随机分为两组，一组为rhG-CSF联合小剂量Dec(G-Dec组：100µg/m2，0-5 d；5 mg/m2，12-5 d)，另一组不干预(非G-Dec组)。主要结果是移植后复发，次要结果是慢性移植物抗宿主病(CGVHD)，治疗的安全性和存活率。结果两年累积复发率在G-DEC组为15.0%(95%CI，8.0%~22.1%)，而非G-DEC组为38.3%(95%CI，28.8%~47.9%)，危险比(HR)为0.32(95%CI，0.18~0.57；P<；01)。G-Dec组和非G-Dec组的2年无复发cGVHD累积发生率分别为23.0%[95%CI，14.7%~31.3%]和21.7%[95%CI，13.6%~29.7%]，差异无统计学意义(P=.82)，HR为1.07(95%CI，0.60~1.92；P=.81)。重组人粒细胞集落刺激因子联合小剂量DEC维持后，自然杀伤细胞、CD8+T细胞和调节性T细胞数量增加。结论rhG-CSF联合小剂量Dec维持可降低allo-HSCT后复发的发生率，同时伴有淋巴细胞亚群的变化。
PURPOSE Relapse is a major cause of treatment failure after allogeneic hematopoietic stem-cell transplantation (allo-HSCT) for high-risk acute myeloid leukemia (HR-AML). The aim of this study was to explore the effect of recombinant human granulocyte colony-stimulating factor (rhG-CSF) combined with minimal-dose decitabine (Dec) on the prevention of HR-AML relapse after allo-HSCT. PATIENTS AND METHODS We conducted a phase II, open-label, multicenter, randomized controlled trial. Two hundred four patients with HR-AML who had received allo-HSCT 60-100 days before randomization and who were minimal residual disease negative were randomly assigned 1:1 to either rhG-CSF combined with minimal-dose Dec (G-Dec group: 100 µg/m2 of rhG-CSF on days 0-5 and 5 mg/m2 of Dec on days 1-5) or no intervention (non–G-Dec group). The primary outcome was relapse after transplantation, and the secondary outcomes were chronic graft-versus-host disease (cGVHD), safety of the treatment, and survival. RESULTS The estimated 2-year cumulative incidence of relapse in the G-Dec group was 15.0% (95% CI, 8.0% to 22.1%), compared with 38.3% (95% CI, 28.8% to 47.9%) in the non–G-Dec group (P < .01), with a hazard ratio (HR) of 0.32 (95% CI, 0.18 to 0.57; P < .01). There was no statistically significant difference between the G-Dec and non–G-Dec groups in the 2-year cumulative incidence of cGVHD without relapse (23.0% [95% CI, 14.7% to 31.3%] and 21.7% [95% CI, 13.6% to 29.7%], respectively; P = .82), with an HR of 1.07 (95% CI, 0.60 to 1.92; P = .81). After rhG-CSF combined with minimal-dose Dec maintenance, increasing numbers of natural killer, CD8+ T, and regulatory T cells were observed. CONCLUSION Our findings suggest that rhG-CSF combined with minimal-dose Dec maintenance after allo-HSCT can reduce the incidence of relapse, accompanied by changes in the number of lymphocyte subtypes.
影响因子：
3.7
作者：
Ukena SN;Velaga S;Goudeva L;Ivanyi P;Olek S;Falk CS;Ganser A;Franzke A
通讯作者：
Franzke A