Hematopoietic cell transplantation for older acute myeloid leukemia patients in first complete remission: results of a randomized phase III study.

Newly diagnosed AML patients in CR1 aged 60-75 years were registered and a donor search initiated.

新诊断的AML患者，年龄在60-75岁之间，处于CR1状态，并已登记注册，同时发起了供体搜索。

After one consolidation cycle, patients with a matched donor were randomized to HCT with fludarabine/low-dose total body irradiation and cyclosporine/mycophenolate mofetil immunosuppression or conventional non-HCT.

经过一个巩固周期后，有匹配供体的患者被随机分配接受以氟达拉滨/低剂量全身照射和环孢素/麦考酚酸酯免疫抑制剂的造血干细胞移植（HCT）治疗，或接受常规的非HCT治疗。

Primary outcome was restricted mean leukemia-free survival (RM-LFS) up to 5 years.

主要结果是限制性平均无白血病生存期（RM-LFS），观察期为5年。

Between 2010 and 2017, 245 patients (median age 67 years) were registered at CR1.

2010年至2017年间，共有245名患者（中位年龄67岁）在CR1注册。

After one consolidation, 26.9% of patients failed inclusion criteria.

经过一次巩固治疗后，26.9%的患者未满足纳入标准。

Of the 179 (73%) patients still on study, 75.4% had an HLA identical donor.

在仍在研究中的179名（73%）患者中，有75.4%的患者拥有HLA完全相合的供者。

Ten ineligible patients were excluded, and 125 randomized to HCT (N=83) or non-HCT (N=42).

排除了10名不符合条件的患者，125名患者被随机分配接受造血干细胞移植（HCT）（N=83）或非造血干细胞移植（N=42）。

The primary outcome RM-LFS up to 5 years was 24.5 months (95% confidence interval[CI]: 18.9-30.1) in the HCT and 15.6 months (95% CI: 10.4-20.8) in the non-HCT arm (P=0.022) due to a decrease in cumulative relapse incidencefrom 91.1% (95% CI: 80.7-100.0) after non-HCT to 37.8% (95% CI: 27.2-48.4) after HCT (P<0.0001).

主要结果 RM-LFS 在 5 年内为 HCT 组 24.5 个月 (95% 置信区间 [CI]: 18.9-30.1) 和非 HCT 组 15.6 个月 (95% CI: 10.4-20.8) (P=0.022)，这是由于非 HCT 后累积复发发生率从 91.1% (95% CI: 80.7-100.0) 降低到 HCT 后的 37.8% (95% CI: 27.2-48.4) (P<0.0001)。

The secondary endpoints RM-OS up to 5 years was 27.8 months (95% CI:22.3-33.2) in the HCT as compared to 28.6 months (95% CI: 22.2-35.0) in the non-HCT arm; non-relapse mortality at 5 years was 33.4% (95% CI: 23.0-43.9) with HCT and 0% without.

次要终点 RM-OS 在 5 年内为 HCT 组 27.8 个月 (95% CI:22.3-33.2)，而非 HCT 组为 28.6 个月 (95% CI: 22.2-35.0)；5 年内非复发死亡率为 HCT 组 33.4% (95% CI: 23.0-43.9)，非 HCT 组为 0%。

In older patients with AML in CR1 5-year RM-LFS is better with HCT than with non-HCT consolidation treatment.

在初治完全缓解的老年急性髓细胞性白血病（AML）患者中，与非造血干细胞移植（HCT）巩固治疗相比，HCT患者的5年复发相关无事件生存（RM-LFS）更好。

The long-term RM-LFS benefit did not translate into a better RM-OS during the study period.

长期的复发相关无事件生存（RM-LFS）优势在研究期间并未转化为更好的复发相关总生存（RM-OS）。