Impact of hematopoietic cell transplantation and quizartinib in newly diagnosed patients with acute myeloid leukemia and FMS-like tyrosine kinase 3-internal tandem duplications in the QuANTUM-First trial.

We evaluated the impact of allo-HCT performed in first complete remission (CR1) or composite CR1 (CRc1) on overall survival(OS), considering treatment randomization.

我们评估了在首次完全缓解 (CR1) 或复合 CR1 (CRc1) 期间进行的 allo-HCT 对总生存 (OS) 的影响，考虑了治疗随机化。

Post-hoc extended Cox regression multivariable analyses were conducted in patients who achieved complete remission/composite complete remission by the end of induction, including allo-HCT in CR1/CRc1 as a time-dependent variable to identify prognostic and predictive factors for OS.

在诱导治疗结束时达到完全缓解/完全综合缓解的患者中进行了事后扩展的Cox回归多变量分析，将首次完全缓解期间的异基因造血干细胞移植（allo-HCT）作为时间依赖变量，以识别总生存的预后和预测因素。

There were 297 patients with complete remission by the end of induction (quizartinib, N=147; placebo, N=150); of these, 157 (52.9%) underwent allo-HCT in CR1 (quizartinib, N=84; placebo, N=73).

在诱导治疗结束时共有297名患者达到完全缓解（quizartinib，N=147；安慰剂，N=150）；其中157名（52.9%）在首次完全缓解期间接受了异基因造血干细胞移植（quizartinib，N=84；安慰剂，N=73）。

There were 368 patients with composite complete remission by the end of induction (quizartinib, N=192; placebo, N=176); of these, 196 (53.3%) underwent allo-HCT in CRc1 (quizartinib, N=110; placebo, N=86).

在诱导治疗结束时，共有368名患者达到复合完全缓解（quizartinib组，N=192；安慰剂组，N=176）；其中196名（53.3%）在CRc1期接受了异基因造血干细胞移植（allo-HCT）（quizartinib组，N=110；安慰剂组，N=86）。

Multivariable analyses revealed quizartinib treatment and allo-HCT in either CR1 (hazard ratio[HR]=0.553, 95% confidence interval[95% CI]: 0.383-0.798, P=0.0015 and HR=0.527, 95% CI: 0.349-0.796, P=0.0023, respectively) or CRc1 (HR=0.645, 95% CI: 0.470‒0.886, P=0.0068 and HR=0.557, 95% CI: 0.391-0.793, P=0.0012, respectively) as significant predictive factors for a longer OS.

多变量分析显示，quizartinib治疗以及在CR1期或CRc1期进行异基因造血干细胞移植（allo-HCT）是总生存期（OS）延长的重要预测因素（分别为HR=0.553，95% 置信区间[95% CI]: 0.383-0.798，P=0.0015和HR=0.527，95% CI: 0.349-0.796，P=0.0023；以及HR=0.645，95% CI: 0.470‒0.886，P=0.0068和HR=0.557，95% CI: 0.391-0.793，P=0.0012）。

No new safety signals were identified.

未发现新的安全信号。

Patients who underwent protocol-specified allo-HCT in CR1/CRc1 experienced post-transplant-related complications, mostly grade ≥2 graft-versus-host disease, as expected.

在CR1/CRc1中接受方案指定的异基因造血干细胞移植（allo-HCT）的患者，如预期，经历了移植相关的并发症，主要是2级或更高级别的移植物抗宿主病。

This post-hoc analysis further supports the use of quizartinib and allo-HCT in CR1/CRc1 as an efficacious and well-tolerated treatment strategy for newly diagnosed FLT3-ITD-positive AML patients fit for intensive chemotherapy.

这项事后分析进一步支持了将quizartinib和allo-HCT用于CR1/CRc1作为针对新诊断的、适合强化疗的FLT3-ITD阳性急性髓性白血病（AML）患者的有效且耐受性良好的治疗策略。