rhG-CSF 联合地西他滨预防高危 MRD 阴性 AML 患者 HSCT 后复发的疗效：一项开放标签、多中心、随机对照试验。
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.
机构信息
Medical Center of Hematology, Xinqiao Hospital, Army Medical University, Chongqing, China.
Department of Health Statistics, College of Military Preventive Medicine, Army Medical University, Chongqing, China.
出版信息
J Clin Oncol. 2020 Dec 20;38(36):4249-4259. doi: 10.1200/JCO.19.03277. Epub 2020 Oct 27.
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/m of rhG-CSF on days 0-5 and 5 mg/m 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 ( < .01), with a hazard ratio (HR) of 0.32 (95% CI, 0.18 to 0.57; < .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; = .82), with an HR of 1.07 (95% CI, 0.60 to 1.92; = .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.
目的
复发是异基因造血干细胞移植（allo-HSCT）治疗高危急性髓系白血病（HR-AML）后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）对预防 allo-HSCT 后 HR-AML 复发的影响。
患者和方法
我们进行了一项 II 期、开放标签、多中心、随机对照试验。204 例 HR-AML 患者在随机分组前接受 allo-HSCT 60-100 天，且微小残留病阴性，按 1:1 随机分配至 rhG-CSF 联合小剂量 Dec（G-Dec 组：rhG-CSF 100μg/m 于第 0-5 天，Dec 5mg/m 于第 1-5 天）或无干预（非-G-Dec 组）。主要结局为移植后复发，次要结局为慢性移植物抗宿主病（cGVHD）、治疗安全性和生存情况。
结果
G-Dec 组 2 年累积复发率为 15.0%（95%CI，8.0%至 22.1%），而非-G-Dec 组为 38.3%（95%CI，28.8%至 47.9%）（ <.01），风险比（HR）为 0.32（95%CI，0.18 至 0.57； <.01）。G-Dec 组和非-G-Dec 组无复发的 2 年累积 cGVHD 发生率分别为 23.0%（95%CI，14.7%至 31.3%）和 21.7%（95%CI，13.6%至 29.7%）（ =.82），HR 为 1.07（95%CI，0.60 至 1.92； =.81）。rhG-CSF 联合小剂量 Dec 维持治疗后，自然杀伤细胞、CD8+T 细胞和调节性 T 细胞的数量增加。
结论
我们的研究结果表明，allo-HSCT 后 rhG-CSF 联合小剂量 Dec 维持治疗可降低复发率，并伴有淋巴细胞亚群数量的变化。
Zotero 插件