干扰素-α 对异基因造血干细胞移植后 t(8;21) 急性髓系白血病患者微小残留病的治疗有效：一项前瞻性登记研究的结果。
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.
机构信息
Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Beijing, People's Republic of China.
Peking University People's Hospital, Peking University Institute of Hematology, Beijing Key Laboratory of Hematopoietic Stem Cell Transplantation, Beijing, People's Republic of China
出版信息
Oncologist. 2018 Nov;23(11):1349-1357. doi: 10.1634/theoncologist.2017-0692. Epub 2018 Aug 3.
BACKGROUND
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; =42).
SUBJECTS, MATERIALS, AND METHODS: MRD-positive status was defined as a <4.5-log reduction from diagnosis in 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 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.
背景
转录本水平已被确立为预测 t(8;21) 急性髓系白血病 (AML) 患者复发的有力标志物。我们旨在确定微小残留病 (MRD) 指导的干扰素-α (IFN-α) 治疗在异基因造血干细胞移植 (allo-HSCT) 后 MRD 阳性的 t(8;21) AML 患者中的疗效(=42)。
受试者、材料和方法：MRD 阳性状态定义为在 转录本中从诊断时降低<4.5 对数，或在 HSCT 后 3 个月时丧失≥4.5 对数的降低。MRD 阳性的患者接受了 6 个周期的 IFN-α治疗（每 4 周周期 2 或 3 次，每周一次）。
结果
MRD 指导的 IFN-α治疗后的 1 年累积严重急性和慢性移植物抗宿主病发生率分别为 7.1%和 4.8%。治疗后，15 名（35.7%）、5 名（11.9%）、3 名（7.1%）和 9 名（21.5%）患者在 1、2、3 和>3 个月时分别达到 MRD 阴性。3 名患者在 IFN-α治疗后复发，1 年复发累积发生率为 7.2%。1 名患者在治疗后 460 天死于严重感染。治疗后 1 年无事件生存率、无病生存率和总生存率分别为 76.0%、92.4%和 92.5%。接受 MRD 指导的 IFN-α治疗的患者的临床结局明显优于历史队列中未接受任何干预的 MRD 阳性患者。
结论
MRD 指导的 IFN-α治疗对 allo-HSCT 后 MRD 阳性的 t(8;21) AML 患者有效。该研究在 http://clinicaltrials.gov 上注册为 NCT02027064。
意义
在 t(8;21) 急性髓系白血病 (AML) 患者中，通过 转录本水平测量的异基因造血干细胞移植 (allo-HSCT) 后微小残留病 (MRD) 的存在已被确立为预测复发的有力标志物。干扰素-α (IFN-α) 可发挥较强的移植物抗白血病作用，MRD 指导的 IFN-α 治疗对 allo-HSCT 后 MRD 阳性的 t(8;21) AML 患者有效。
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