Quizartinib for patients with newly diagnosed FLT3-ITD-positive AML who received maintenance therapy in QuANTUM-First.

Herein, we evaluated the impact of postconsolidation/posttransplant single-agent maintenance therapy on clinical outcomes in patients receiving maintenance, focusing on measurable residual disease (MRD) status at maintenance onset.

在此项研究中，我们评估了巩固治疗/移植后单药维持治疗对接受维持治疗患者临床结果的影响，特别关注维持治疗开始时的可测量残留病（MRD）状态。

OS, event-free survival, and relapse-free survival were prespecified exploratory analyses.

总生存、无事件生存和无复发生存期是预先设定的探索性分析。

Cumulative incidenceof relapse, analyses by allogeneic hematopoietic cell transplant (allo-HCT), and analyses by MRD status were post hoc and not powered for statistical significance.

复发的累积发生率、按异基因造血干细胞移植（allo-HCT）的分析以及按微小残留病（MRD）状态的分析是事后分析，未针对统计显著性进行功效分析。

Samples for FLT3-ITD MRD analysis were collected from patients with composite complete remission ≤30 days before receiving maintenance and assessed using an ultrasensitive amplicon-based assay.

FLT3-ITD MRD分析的样本是从复合完全缓解≤30天前接受维持治疗的患者中收集的，并使用超灵敏扩增子基础检测法进行评估。

More patients who had received an allo-HCT and quizartinib treatment received maintenance (71%) vs placebo (55%); OS benefit was not demonstrated among these patients.

接受异基因造血干细胞移植（allo-HCT）和quizartinib治疗的患者中，有更多的人接受了维持治疗（71%）而非安慰剂（55%）；这些患者中并未显示出总生存（OS）的益处。

In patients who did not undergo allo-HCT, quizartinib maintenance was associated with a significant OS benefit (hazard ratio[HR], 0.401; 95% confidence interval[CI], 0.192-0.838), including a benefit in patients who were MRD negative at the start of maintenance (OS HR, 0.194; 95% CI, 0.056-0.676).

在接受异基因造血干细胞移植（allo-HCT）的患者中，quizartinib维持治疗与显著的总生存（OS）益处相关（风险比[HR]，0.401；95%置信区间[CI]，0.192-0.838），包括在维持治疗开始时微小残留病（MRD）阴性的患者（OS HR，0.194；95% CI，0.056-0.676）。

Patients who were MRD negative at the completion of consolidation achieved 89.1% (95% CI, 70.0-96.4) survival at 3 years with quizartinib maintenance in the absence of allo-HCT.

在巩固治疗结束时MRD阴性的患者，在没有进行allo-HCT的情况下，使用quizartinib维持治疗，3年生存率达到89.1%（95% CI，70.0-96.4）。

These data suggest that for patients who achieve FLT3-ITD MRD negativity after induction and consolidation with quizartinib, maintenance with quizartinib provides a significant survival benefit and, in some patients, may eliminate the need for allo-HCT.

这些数据表明，对于在接受quizartinib诱导和巩固治疗后达到FLT3-ITD MRD阴性的患者，继续使用quizartinib作为维持治疗可以显著提高生存益处，并且在某些患者中，可能无需进行异基因造血干细胞移植（allo-HCT）。

This trial was registered at www.clinicaltrials.gov as NCT02668653.

该试验已在www.clinicaltrials.gov上注册，注册号为NCT02668653。