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Title: Interferon-α Is Effective for Treatment of Minimal Residual Disease in Patients with t(8;21) Acute Myeloid Leukemia After Allogeneic Hematopoietic Stem Cell Transplantation: Results of a Prospective Registry Study.
Author: Mo XD, Wang Y, Zhang XH, Xu LP, Yan CH, Chen H, Chen YH, Qin YZ, Liu KY, Huang XJ.
Journal: Oncologist; 2018 Nov; 23(11):1349-1357. PubMed ID: 30076280.
Abstract:
BACKGROUND: RUNX1-RUNX1T1 transcript levels were established as a powerful marker for predicting relapse in patients with t(8;21) acute myeloid leukemia (AML). We aimed to identify the efficacy of minimal residual disease (MRD)-directed interferon-alpha (IFN-α) treatment in patients with t(8;21) AML who were positive for MRD after allogeneic hematopoietic stem cell transplantation (allo-HSCT; n=42). SUBJECTS, MATERIALS, AND METHODS: MRD-positive status was defined as a <4.5-log reduction from diagnosis in RUNX1-RUNX1T1 transcripts and/or the loss of a ≥4.5-log reduction after 3 months after HSCT. Patients with positive MRD received six cycles of IFN-α treatment (twice or thrice weekly of every 4 weeks cycle). RESULTS: The 1-year cumulative incidence of severe acute and chronic graft-versus-host disease after MRD-directed IFN-α treatment was 7.1% and 4.8%, respectively. After the treatment, 15 (35.7%), 5 (11.9%), 3 (7.1%), and 9 (21.5%) patients achieved MRD negativity at 1, 2, 3, and >3 months, respectively. Three patients relapsed after the IFN-α treatment, in which the 1-year cumulative incidence of relapse was 7.2%. One patient died of severe infection at 460 days after treatment. The 1-year probabilities of event-free survival, disease-free survival, and overall survival after treatment were 76.0%, 92.4%, and 92.5%, respectively. The clinical outcomes in patients who received MRD-directed IFN-α treatment were significantly better than those of the MRD-positive patients without any interventions in the historical cohort. CONCLUSION: MRD-directed IFN-α treatment is effective for patients with t(8;21) AML who were MRD-positive after allo-HSCT. The study was registered at http://clinicaltrials.gov as NCT02027064. IMPLICATIONS FOR PRACTICE: In patients with t(8;21) acute myeloid leukemia (AML), the presence of post-allogeneic hematopoietic stem cell transplantation (allo-HSCT) minimal residual disease (MRD), measured by RUNX1-RUNX1T1 transcript levels, has been established as a powerful marker for predicting relapse. Interferon-alpha (IFN-α) could exert a relatively strong graft-versus-leukemia effect, and MRD-directed IFN-α treatment is effective for patients with t(8;21) AML who were MRD-positive after allo-HSCT. 摘要 背景。研究确定,RUNX1‐RUNX1T1 转录水平是预测 t(8;21) 急性髓性白血病 (AML) 患者复发的有力标志物。我们旨在确定微小残留病 (MRD) 定向干扰素‐α (IFN‐α) 治疗对在异基因造血干细胞移植(allo‐HSCT)后 MRD阳性的 (8;21) AML 患者(n = 42)的效果。 受试者、材料和方法。MRD 阳性状态的定义为通过 RUNX1‐RUNX1T1 转录进行诊断时,对数减少值 <4.5,和/或HSCT 3 个月后,对数减少值 ≥4.5。MRD 阳性患者接受 6 个周期的 IFN‐α 治疗(每周两或三次,每 4 周为一个周期)。 结果。经过 MRD 定向 IFN‐α 治疗后,严重急性和慢性移植物抗宿主病的 1 年累积发病率分别为 7.1% 和 4.8%。治疗后,分别有 15 (35.7%)、5 (11.9%)、3 (7.1%) 和 9 (21.5%)名患者在 1、2、3 和 >3 个月时 MRD 达到了阴性。三名患者在 IFN‐α 治疗后复发,其中 1 年累积复发率为 7.2%。一名患者在治疗后 460 天死于严重感染。治疗后的 1 年无事件生存期、无病生存期和总生存期百分比分别为 76.0%、92.4% 和 92.5%。接受 MRD 定向 IFN‐α 治疗的患者的临床效果明显优于在历史性队列中未经过任何干预治疗的 MRD 阳性患者。 结论。MRD 定向 IFN‐α 治疗对allo‐HSCT后的 MRD 阳性 t(8;21) AML 患者有效。该研究在 http://clinicaltrials.gov 上的登记编号为 NCT02027064。 对临床实践的提示: 在患有 t(8;21) 急性髓性白血病 (AML) 的患者中,以 RUNX1‐RUNX1T1 转录水平测量的异基因造血干细胞移植 (allo‐HSCT) 微小残留病 (MRD) 的发病率已被确定为预测其复发的有力标志物。干扰素‐α (IFN‐α) 可以发挥较为强大的移植物抗白血病作用,MRD 定向 IFN‐α 治疗对 allo‐HSCT 后 MRD 呈阳性的 t(8;21) AML 患者有效。

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