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临床输血与检验

临床输血与检验 ›› 2022, Vol. 24 ›› Issue (6): 791-797.DOI: 10.3969/j.issn.1671-2587.2022.06.021

• 临床研究 • 上一篇    下一篇

不同剂量伊达比星联合阿糖胞苷对60岁以下成人急性髓系白血病诱导疗效的临床研究

汪小钰, 刘丹, 张旭晗, 孙光宇, 陈二玲, 周紫微, 薛磊, 童娟, 周莉, 郑昌成   

  1. 230001 安徽医科大学附属省立医院血液科（汪小钰,郑昌成）; 中国科学技术大学附属第一医院血液科（张旭晗,孙光宇,陈二玲,周紫微,薛磊,童娟,周莉,郑昌成）; 皖南医学院（刘丹）
  • 收稿日期:2022-06-20 发布日期:2023-01-05
  • 通讯作者: 郑昌成,男,主任医师,博士,主要从事血液病方向研究,（E-mail）zhengchch1123@ustc.edu.cn。
  • 作者简介:汪小钰（1999-）,女,安徽安庆人,医师,学士,主要从事血液学相关研究,（E-mail）wangxyzb123@163.com。

A Clinical Study on the Induction Effect of Different doses of Idarubicin Combined with Cytarabine on Acute Myeloid Leukemia in Adults Under 60 Years of Age

WANG Xiao-yu, LIU Dan, ZHANG Xu-han, et al   

  1. Department of Hematology,Anhui Provincial Hosptial,Anhui Medical University,Hefei 230001
  • Received:2022-06-20 Published:2023-01-05

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摘要： 目的 探讨不同剂量的蒽环类药物伊达比星（IDA）对于60岁以下成人急性髓系白血病（AML）患者诱导治疗的临床疗效。方法 从2015年6月~2019年12月,本中心共诊断265例年轻（14~59岁）AML患者,回顾性分析了239例使用伊达比星联合阿糖胞苷（IA 3+7）方案诱导治疗的患者,重点关注完全缓解（CR）率、复发以及不同预后风险组患者的长期生存。结果 在接受首次诱导治疗后,IDA 8 mg/m2组和IDA 10~12 mg/m2组分别有61例（65.6%）和103例（70.6%）患者获得形态CR（P=0.475）,其中IDA 8 mg/m2组26例（42.6%）患者微小残留病灶（MRD）转阴,IDA 10~12 mg/m2组64例（62.1%）患者MRD转阴（P=0.048）。IDA 8 mg/m2组和IDA 10~12 mg/m2组3年疾病累积复发率分别为45.1%（95%CI：34.1%~57.8%）和49.6%（95%CI：40.7%~59.3%）（P=0.469）。IDA 8 mg/m2组3年总生存（OS）率为34.6%（95%CI：24.9%~44.4%）明显低于IDA 10~12 mg/m2组46.6%（95%CI：38.2%~54.6%）（P=0.038）;其中预后中等组IDA 8 mg/m2组3年OS率为31.5%（95%CI：18.9%~45.0%）,明显低于IDA 10~12 mg/m2组的为43.7%（95%CI：32.3%~54.6%）（P=0.043）。3年无事件生存（EFS）率IDA 8 mg/m2组和IDA 10~12 mg/m2组分别为32.0%（95%CI：22.7%~41.6%）和37.0%（95%CI：29.2%~44.8%）（P=0.319）;其中预后中等组IDA 8 mg/m2组为25.4%（95%CI：14.0%~38.4%）稍低于IDA 10~12 mg/m2组33.3%（95%CI：23.0%~44.0%）（P=0.107）。3年OS率和3年EFS率无论在预后良好组还是在预后不良组均未见明显差异。结论 对于年轻成人AML患者,特别是对于2017ELN风险分层为预后中等的患者,使用伊达比星10~12 mg•m-2•d-1×3 d为基础的IA （3+7）方案诱导治疗能够获得更高的免疫学缓解和更好地长期生存。

关键词: 急性髓系白血病, 伊达比星, ELN预后风险分层, 诱导治疗, 微小残留病

Abstract: Objective To investigate the clinical efficacy of different doses of anthracycline idarubicin in the induction treatment of acute myeloid leukemia（AML）for adults aged less than 60. Methods A total of 265 young AML patients（14~59 years old）were diagnosed at our center from June 2015 to December 2019. We retrospectively reviewed 239 patients treated with the regimen of idarubicin combined with cytarabine（IA 3+7）,focusing on complete remission（CR）rate,recurrence and long-term survival in patients with different prognostic risk groups. Results After the first induction therapy,61（65.6%）and 103（70.6%） patients in the IDA 8 mg/m2 group and the IDA 10~12 mg/m2 group obtained morphological CR（P=0.475）,of which 26 patients（42.6%）in the IDA 8 mg/m2 group and 64 patients（62.1%）in the IDA 10~12 mg/m2 group had minimal residual disease（MRD）negativity. The 3-year cumulative incidence of relapse（CIR） was 45.1%（95% CI：34.1%~57.8%）in the IDA 8 mg/m2 group and 49.6% （95% CI：40.7%~59.3%） in the IDA 10~12 mg/m2 group（P=0.469）. The 3-year overall survival（OS）rate was lower in the IDA 8 mg/m2 group [34.6%（95% CI：24.9%~44.4%）] than in the IDA 10~12 mg/m2 group [46.6%（95% CI：38.2%~54.6%）] （P=0.038）. For intermediate-risk patients,the 3-year OS rate for patients in the IDA 8 mg/m2 group was 31.5%（95% CI：18.9%~45.0%）,which was significantly lower than that in the IDA 10~12 mg/m2 group [43.7%（95% CI：32.3%~54.6%）] （P=0.043）. The 3-year event-free survival（EFS） rate in the IDA 8 mg/m2 group and the IDA 10~12 mg/m2 group were 32.0% （95% CI：22.7%~41.6%）and 37.0%（95% CI：29.2%~44.8%）respectively（P=0.319）. For intermediate-risk patients, there was a lower trend of the 3-year EFS rate in the IDA 8 mg/m2 group [25.4%（95% CI：14.0%~38.4%）] than in the IDA 10~12 mg/m2 group [33.3%（95% CI：23.0%~44.0%）] （P=0.107）. There were no significant differences in the 3-year OS rate and 3-year EFS rate between the favourable risk group and the adverse risk group. Conclusion For young adult patients with AML,the induction therapy with IA (3+7) regimen based on idarubicin 10~12 mg•m-2•d-1×3 d could achieve higher immunological remission and better long-term survival,especially for patients with intermediate risk according to 2017 ELN risk stratification.

Key words: Acute myeloid leukemia, IDA, ELN risk stratification, Induction chemotherapy, Minimal residual disease

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