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

作者：Lei Gao, Yanqi Zhang, Sanbin Wang, Peiyan Kong, Yi Su, Jiong Hu, Ming Jiang, Hai Bai, Tao Lang, Jishi Wang, Li Liu, Tonghua Yang, Xiaobing Huang, Fang Liu, Shifeng Lou, Yao Liu, Cheng Zhang, Hong Liu, Li Gao, Jia Liu, Lidan Zhu, Qin Wen, Ting Chen, Ping Wang, Jun Rao, Min Mao, Cunbang Wang, Xianlin Duan, Le Luo, Xiangui Peng, Kaniel Cassady, Jiang F. Zhong, Xi Zhang · 发表于：Journal of Clinical Oncology · 年份：2020 · DOI：10.1200/jco.19.03277 · 被引用次数：148 · 研究领域：Acute Myeloid Leukemia Research、Hematopoietic Stem Cell Transplantation、Acute Lymphoblastic Leukemia research

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 2 of rhG-CSF on days 0-5 and 5 mg/m 2 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),...