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

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...

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Detalles Bibliográficos
Autores principales: Gao, Lei, Zhang, Yanqi, Wang, Sanbin, Kong, Peiyan, Su, Yi, Hu, Jiong, Jiang, Ming, Bai, Hai, Lang, Tao, Wang, Jishi, Liu, Li, Yang, Tonghua, Huang, Xiaobing, Liu, Fang, Lou, Shifeng, Liu, Yao, Zhang, Cheng, Liu, Hong, Gao, Li, Liu, Jia, Zhu, Lidan, Wen, Qin, Chen, Ting, Wang, Ping, Rao, Jun, Mao, Min, Wang, Cunbang, Duan, Xianlin, Luo, Le, Peng, Xiangui, Cassady, Kaniel, Zhong, Jiang F., Zhang, Xi
Formato: Online Artículo Texto
Lenguaje:English
Publicado: American Society of Clinical Oncology 2020
Materias:
ORIGINAL REPORTS
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7768335/
https://www.ncbi.nlm.nih.gov/pubmed/33108244
http://dx.doi.org/10.1200/JCO.19.03277
Descripción
Sumario: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), 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.

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