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

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.

符合条件的AML患者在首次完全缓解后，按1:1的比例随机分配接受高剂量阿糖胞苷联合伊达比星（IA3 + 3）（伊达比星10 mg/m2，第1-3天，阿糖胞苷2 g/m2，每12小时一次，第1-3天）或仅接受高剂量阿糖胞苷（HDAC）（阿糖胞苷3 g/m2，每12小时一次，第1-3天）方案作为首次巩固治疗。

The primary endpoint was the rate of negative measurable residual disease (MRD-) after first consolidation.

主要终点是首次巩固治疗后可测量的微小残留病灶阴性（MRD-）的比率。

Between November 2018 and December 2021, 407 patients were assigned to IA3 + 3 (n = 204) or HDAC (n = 203) groups.

在2018年11月至2021年12月期间，共有407名患者被分配到IA3+3组（n = 204）或HDAC组（n = 203）。

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).

IA3 + 3 和 HDAC 组首次巩固治疗后 MRD- 的比例分别为 65.2% (95% 置信区间: 58.6-71.8%) 和 53.2% (46.3-60.1%) (P = 0.009).

The 3-year cumulative incidenceof 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.

两组的3年复发累积发生率为 22.6% (95% 置信区间: 16.8-29.0%) 和 34.0% (27.1-41.1%) (P = 0.014)，无病生存期(DFS)为 68.4% (61.5-75.3%) 和 52.9% (45.4-60.5%) (P = 0.003)，总生存(OS)为 75.5% (69.0-82.1%) 和 69.6% (62.4-76.7%) (P = 0.18)，治疗相关死亡率为 8.8% (5.2-13.6%) 和 13.0% (8.5-18.5%) (P = 0.23).

Eighty-seven (43%) and 114 (56%) patients underwent allogeneic hematopoietic stem cell transplantation (allo-HSCT), respectively (P = 0.006).

分别有87名（43%）和114名（56%）患者接受了异基因造血干细胞移植（allo-HSCT），差异具有统计学意义（P = 0.006）。

IA3 + 3 regimen results in deeper remissions and reduces relapse compared to HDAC.

IA3 + 3方案相较于HDAC方案，能够实现更深层次的缓解并减少复发。

This deeper remission improves DFS and translates into treatment advantage, with fewer patients undergoing allo-HSCT.

这种更深层次的缓解改善了无病生存期（DFS），并转化为治疗优势，使得接受异基因造血干细胞移植（allo-HSCT）的患者数量减少。

(ClinicalTrials.gov, NCT03620955).

(ClinicalTrials.gov, NCT03620955).