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：[1]Medical Center of Hematology, Xinqiao Hospital, Army MedicalUniversity, Chongqing, China[2]Department of Health Statistics, College of Military PreventiveMedicine, Army Medical University, Chongqing, China[3]Department of Hematology, General Hospital of Kunming MilitaryRegion of the People’s Liberation Army (PLA), Kunming, China[4]Department of Hematology, General Hospital of Chengdu MilitaryRegion of the PLA, Chengdu, China[5]Department of Hematology, Ruijin Hospital, Shanghai Jiao TongUniversity, Shanghai, China[6]Department of Hematology, the Affiliated Hospital of Xinjiang MedicalUniversity, Urumqi, China[7]Department of Hematology, General Hospital of Lanzhou Military Regionof the PLA, Lanzhou, China[8]Department of Hematology, Xinjiang Provincial People’s Hospital,Urumqi, China[9]Department of Hematology, Affiliated Hospital of Guiyang MedicalUniversity, Guiyang, China[10]Department of Hematology, Tangdu Hospital, Forth Military MedicalUniversity (Air Force Medical University), Xi’an, China[11]Department of Hematology, Yunnan Provincial People’s Hospital,Kunming, China[12]Department of Hematology, Sichuan Provincial People’s Hospital,Chengdu, China四川省人民医院[13]Department of Hematology, the Second Affiliated Hospital ofChongqing Medical University, Chongqing, China[14]Departments of Diabetes Immunology and Hematology/HematopoieticCell Transplantation, Beckman Research Institute, City of Hope, Duarte,CA[15]Department of Otolaryngology, Keck School of Medicine, University ofSouthern California, CA
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.
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.
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.
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.
基金：
Supported by the National Key Research and Development Program of
China (Grants No. 2016YFA0202104 and 2017YFA0105502), the
Chinese National Natural Science Foundation (Grants No. 81370593,81570131, 81570097, and 81873424), the Chongqing Social
Undertakings, People’s Livelihood Guarantee and Technology Innovation
Foundation (Grant No. cstc2016shms-ztzx10003), the Chongqing Key
Project of Basic and Frontier Research Program (Grant No.
cstc2015jcyjBX0077), the Chongqing National Natural Science Key
Foundation (Grant No. cstc2019jcyj-zdxmX0023), the Research Fund
from the Clinical Foundation of Army Medical University (Grants No.
2018JSLC0034 and 2018XLC1006), and Xinqiao Hospital (Grant No.
2018YQYLY007). This article is the authors’ own work and not an official
position of the institution or funder.
第一作者机构：[1]Medical Center of Hematology, Xinqiao Hospital, Army MedicalUniversity, Chongqing, China
共同第一作者：
通讯作者：
通讯机构：[1]Medical Center of Hematology, Xinqiao Hospital, Army MedicalUniversity, Chongqing, China[*1]Medical Center of Hematology, Xinqiao Hospital, The Army Medical University, Chongqing 400037, China
推荐引用方式(GB/T 7714)：
Lei Gao,Yanqi Zhang,Sanbin Wang,et al.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.[J].JOURNAL OF CLINICAL ONCOLOGY.2020,38(36):4249-+.doi:10.1200/JCO.19.03277.
APA：
Lei Gao,Yanqi Zhang,Sanbin Wang,Peiyan Kong,Yi Su...&Xi Zhang.(2020).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..JOURNAL OF CLINICAL ONCOLOGY,38,(36)
MLA：
Lei Gao,et al."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.".JOURNAL OF CLINICAL ONCOLOGY 38..36(2020):4249-+
医学