Arsenic Trioxide and All-Trans Retinoic Acid Combination Therapy for the Treatment of High-Risk Acute Promyelocytic Leukemia: Results From the APOLLO Trial.

Methods

Adult patients with newly diagnosed high-risk APL in the ATRA-ATO arm received ATO 0.15 mg/kg once daily and ATRA 45 mg/m2 twice daily until complete remission (CR), with two doses of idarubicin 12 mg/m2 on days 1 and 3, followed by consolidation therapy (four ATRA-ATO cycles).

在ATRA-ATO组中，新诊断的高危APL成人患者每天接受一次0.15 mg/kg的ATO和每天两次45 mg/m2的ATRA治疗，直至完全缓解（CR），在第1天和第3天分别给予两次12 mg/m2的伊达比星，随后进行巩固治疗（四个ATRA-ATO周期）。

Patients in the ATRA-CHT arm received induction with ATRA 45 mg/m2 twice daily and idarubicin 12 mg/m2 once daily on days 1, 3, 5, and 7, followed by three cycles of chemotherapy-based consolidation and 2 years of maintenance therapy.

ATRA-CHT组的患者接受ATRA 45 mg/m2每日两次和idarubicin 12 mg/m2每日一次的诱导治疗，治疗时间为第1、3、5和7天，随后进行三个周期的化疗巩固治疗和2年的维持治疗。

The primary study end point was event-free survival (EFS) at 2 years.

主要研究终点是2年的无事件生存（EFS）。

Results

As of July 2022, 133 eligible patients had received either ATRA-ATO (n = 68) or ATRA-CHT (n = 65).

截至2022年7月，共有133名符合条件的患者接受了ATRA-ATO（n = 68）或ATRA-CHT（n = 65）治疗。

The study was discontinued prematurely because of slow accrual during the COVID-19 pandemic.

由于COVID-19大流行期间招募缓慢，该研究被提前终止。

After a median follow-up of 37 months (range, 1.7-88.6 months), 2-year EFS was 88% in the ATRA-ATO arm and 71% in the ATRA-CHT arm (HR, 0.4 [95% CI, 0.17 to 0.92]; log-rank test P = .02).

中位随访时间为37个月（范围，1.7-88.6个月），ATRA-ATO组的2年无事件生存（EFS）率为88%，而ATRA-CHT组为71%（风险比[HR]，0.4 [95% 置信区间，0.17至0.92]；对数秩检验P = .02）。

At a median of 7.8 and 12.1 months from achievement of CR, molecular relapse occurred in one (1.5%) ATRA-ATO patient versus eight (12.3%) ATRA-CHT patients (P = .014).

从达到完全缓解（CR）的中位时间7.8个月和12.1个月来看，ATRA-ATO组有一名患者（1.5%）发生分子复发，而ATRA-CHT组有八名患者（12.3%）发生分子复发（P = .014）。

Overall, 32% and 68% of patients receiving ATRA-ATO and ATRA-CHT, respectively, reported serious treatment-emergent adverse events (P < .01).

总体而言，分别有32%和68%接受ATRA-ATO和ATRA-CHT治疗的患者报告了严重的治疗相关不良事件（P < .01）。

Conclusions

The results of the APOLLO trial support the use of ATO and ATRA for the treatment of newly diagnosed patients with high-risk APL.

APOLLO试验的结果支持使用ATO和ATRA治疗新诊断的高危急性早幼粒细胞白血病（APL）患者。