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<p>Whether adding anthracycline to intermediate- or high-dose cytarabine as consolidation is beneficial remains unclear in acute myeloid leukemia (AML). Eligible AML patients in first complete remission were randomly assigned (1:1) to receive either high-dose cytarabine with idarubicin (IA3 + 3) (idarubicin 10 mg/m<sup>2</sup>, d1-3 and cytarabine 2 g/m<sup>2</sup>, every 12 h, d1-3) or high-dose cytarabine (HDAC) (cytarabine 3 g/m<sup>2</sup>, every 12 h, d1-3) regimens as first consolidation. The primary endpoint was the rate of negative measurable residual disease (MRD<sup>−</sup>) after first consolidation. Between November 2018 and December 2021, 407 patients were assigned to IA3 + 3 (<i>n</i> = 204) or HDAC (<i>n</i> = 203) groups. MRD<sup>−</sup> after first consolidation for IA3 + 3 and HDAC groups was 65.2% (95%CI: 58.6–71.8%) and 53.2% (46.3–60.1%) (<i>P</i> = 0.009). The 3-year cumulative incidence of relapse was 22.6% (95%CI :16.8–29.0%) and 34.0% (27.1–41.1%) (<i>P</i> = 0.014), DFS was 68.4% (61.5–75.3%) and 52.9% (45.4–60.5%) (<i>P</i> = 0.003), OS was 75.5% (69.0–82.1%) and 69.6% (62.4–76.7%) (<i>P</i> = 0.18) and treatment-related mortality was 8.8% (5.2–13.6%) and 13.0% (8.5–18.5%) (<i>P</i> = 0.23) in two groups, respectively. Eighty-seven (43%) and 114 (56%) patients underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT), respectively (<i>P</i> = 0.006). IA3 + 3 regimen results in deeper remissions and reduces relapse compared to HDAC. This deeper remission improves DFS and translates into treatment advantage, with fewer patients undergoing allo-HSCT. (ClinicalTrials.gov, NCT03620955).</p>

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High-dose cytarabine with idarubicin consolidation for acute myeloid leukemia in first complete remission: a randomized controlled trial

  • 期刊论文

  • 发表日期：

    2025年5月28日

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  • Yu Zhang,
  • Zinan Feng,
  • Jing Du,
  • Hui Liu,
  • Sijian Yu,
  • Xinquan Liang,
  • Weihua Zhao,
  • Qing Zhang,
  • Xiong Zhang,
  • Danian Nie,
  • Zhiqiang Sun,
  • Xin Du,
  • Xiaojun Xu,
  • Guopan Yu,
  • Pengcheng Shi,
  • Qianwei Liu,
  • Ruoyang Shao,
  • Hong Qu,
  • Wenjie Xiong,
  • Shunqing Wang,
  • Yirong Jiang,
  • Hongyu Zhang,
  • Ziwen Guo,
  • Min Dai,
  • Xuejie Jiang,
  • Dan Xu,
  • Fen Huang,
  • Zhiping Fan,
  • Na Xu,
  • Can Liu,
  • Meiqing Wu,
  • Ren Lin,
  • Hua Jin,
  • Jing Sun,
  • Qifa Liu,
  • Li Xuan

摘要

Whether adding anthracycline to intermediate- or high-dose cytarabine as consolidation is beneficial remains unclear in acute myeloid leukemia (AML). Eligible AML patients in first complete remission were randomly assigned (1:1) to receive either high-dose cytarabine with idarubicin (IA3 + 3) (idarubicin 10 mg/m2, d1-3 and cytarabine 2 g/m2, every 12 h, d1-3) or high-dose cytarabine (HDAC) (cytarabine 3 g/m2, every 12 h, d1-3) regimens as first consolidation. The primary endpoint was the rate of negative measurable residual disease (MRD−) after first consolidation. Between November 2018 and December 2021, 407 patients were assigned to IA3 + 3 (n = 204) or HDAC (n = 203) groups. MRD− after first consolidation for IA3 + 3 and HDAC groups was 65.2% (95%CI: 58.6–71.8%) and 53.2% (46.3–60.1%) (P = 0.009). The 3-year cumulative incidence of relapse was 22.6% (95%CI :16.8–29.0%) and 34.0% (27.1–41.1%) (P = 0.014), DFS was 68.4% (61.5–75.3%) and 52.9% (45.4–60.5%) (P = 0.003), OS was 75.5% (69.0–82.1%) and 69.6% (62.4–76.7%) (P = 0.18) and treatment-related mortality was 8.8% (5.2–13.6%) and 13.0% (8.5–18.5%) (P = 0.23) in two groups, respectively. Eighty-seven (43%) and 114 (56%) patients underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT), respectively (P = 0.006). IA3 + 3 regimen results in deeper remissions and reduces relapse compared to HDAC. This deeper remission improves DFS and translates into treatment advantage, with fewer patients undergoing allo-HSCT. (ClinicalTrials.gov, NCT03620955).