Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Peking University Institute of Hematology, Peking University People's Hospital, Beijing, China.
Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Peking University Institute of Hematology, Peking University People's Hospital, Beijing, China; Peking-Tsinghua Center for Life Sciences, Academy for Advanced Interdisciplinary Studies, Peking University, Beijing, China.
Biol Blood Marrow Transplant. 2017 Aug;23(8):1303-1310. doi: 10.1016/j.bbmt.2017.04.023. Epub 2017 Apr 27.
The efficacy of minimal residual disease (MRD)-directed IFN-α treatment was investigated in acute leukemia patients who were positive for MRD after allogeneic hematopoietic stem cell transplantation (allo-HSCT) (n = 107). MRD-positive status was defined as positivity for leukemia-associated aberrant immune phenotypes or positivity for Wilms' tumor gene 1 in a single bone marrow sample. Recombinant human IFN-α-2b injections were administered subcutaneously 2 to 3 times per week for 6 months. The 2-year cumulative incidence of severe acute and chronic graft-versus-host disease after IFN-α treatment was 5.7% and 6.6%, respectively. Eighty-one patients (75.7%) turned MRD-negative after IFN-α treatment 1 month (42; 39.3%), 2 months (6; 5.6%), 3 months (7; 6.5%), and >3 months (26; 24.3%) after MRD-directed IFN-α treatment. Twelve patients showed relapse after IFN-α treatment, and 7 died of relapse. Four patients died of nonrelapse mortality (NRM). The 2-year cumulative incidence of relapse, relapse mortality, and NRM after IFN-α treatment was 11.5%, 6.8%, and 4.3%, respectively. The 2-year probabilities of event-free survival, disease-free survival, and overall survival after IFN-α treatment were 66.5%, 82.4%, and 87.4%, respectively. Persistent MRD after IFN-α treatment was significantly associated with higher relapse risk and poorer survival. Thus, MRD-directed IFN-α treatment is effective for patients who were MRD-positive after allo-HSCT. The study was registered at http://clinicaltrials.gov as NCT02185261.
在异基因造血干细胞移植（allo-HSCT）后 MRD 阳性的急性白血病患者中，研究了微小残留病（MRD）指导的 IFN-α 治疗的疗效（n=107）。MRD 阳性状态定义为单个骨髓样本中白血病相关异常免疫表型阳性或 Wilms 肿瘤基因 1 阳性。重组人 IFN-α-2b 皮下注射，每周 2 至 3 次，持续 6 个月。IFN-α 治疗后 2 年严重急性和慢性移植物抗宿主病的累积发生率分别为 5.7%和 6.6%。81 例患者（75.7%）在 IFN-α 治疗后 1 个月（42 例；39.3%）、2 个月（6 例；5.6%）、3 个月（7 例；6.5%）和>3 个月（26 例；24.3%）转为 MRD 阴性。12 例患者在 IFN-α 治疗后复发，7 例死于复发。4 例患者死于非复发相关死亡（NRM）。IFN-α 治疗后 2 年复发、复发相关死亡率和 NRM 的累积发生率分别为 11.5%、6.8%和 4.3%。IFN-α 治疗后 2 年无事件生存、无疾病生存和总生存的概率分别为 66.5%、82.4%和 87.4%。IFN-α 治疗后持续存在 MRD 与更高的复发风险和更差的生存相关。因此，MRD 指导的 IFN-α 治疗对 allo-HSCT 后 MRD 阳性的患者有效。该研究在 http://clinicaltrials.gov 注册，编号为 NCT02185261。
