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
| Autor: | Sanbin Wang, Tao Lang, Jishi Wang, Lidan Zhu, Jiang F. Zhong, Cunbang Wang, Xi Zhang, Jiong Hu, Cheng Zhang, Yi Su, Tonghua Yang, Xian-Gui Peng, Yanqi Zhang, Hai Bai, Yao Liu, Le Luo, Ting Chen, Pei-Yan Kong, Min Mao, Qin Wen, Lei Gao, Jun Rao, Kaniel Cassady, Hong Liu, Shifeng Lou, Jia Liu, Fang Liu, Ming Jiang, Li Gao, Ping Wang, Xianlin Duan, Xiaobing Huang, Li Liu |
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| Rok vydání: | 2020 |
| Předmět: |
Oncology
Adult Male Cancer Research medicine.medical_specialty Antimetabolites Antineoplastic Myeloid Transplantation Conditioning Adolescent Filgrastim Decitabine law.invention Young Adult Randomized controlled trial law Recurrence Risk Factors Internal medicine Antineoplastic Combined Chemotherapy Protocols medicine Humans Young adult Child Bone Marrow Transplantation business.industry Hematopoietic Stem Cell Transplantation Myeloid leukemia ORIGINAL REPORTS Middle Aged medicine.disease Prognosis Transplantation Leukemia Haematopoiesis Leukemia Myeloid Acute medicine.anatomical_structure Child Preschool Female business medicine.drug |
| Zdroj: | Journal of Clinical Oncology |
| ISSN: | 1527-7755 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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