FLT3-ITD measurable residual disease from the QuANTUM-First trial.

We conducted a post hoc analysis of the trial data focusing on measurable residual disease (MRD) as assayed using an amplicon-based next-generation sequencing assay, and on the impact of molecular biomarkers such as FLT3-ITD insertion length and comutations.

我们对试验数据进行了事后分析，重点关注使用扩增子基础的下一代测序检测的可测量残留病灶 (MRD)，以及FLT3-ITD插入长度和共突变等分子生物标志物的影响。

This is, to our knowledge, the first prospective, randomized trial of an FLT3 inhibitor in newly diagnosed patients in which FLT3-ITD MRD data were collected throughout therapy.

据我们所知，这是我们首次在新诊断患者中进行的FLT3抑制剂的前瞻性、随机试验，其中收集了整个治疗期间的FLT3-ITD微小残留病（MRD）数据。

We established that quizartinib induces deeper remissions with respect to FLT3-ITD MRD vs placebo, and that the amount of MRD at the completion of induction correlates with relapse and survival. We found that longer FLT3-ITD insertion mutations correlated with worse outcome, quizartinib was beneficial irrespective of insertion mutation length, and the FLT3-ITD MRD assay was more sensitive when bone marrow was used vs peripheral blood.

我们确定了quizartinib相对于安慰剂能诱导更深层次的FLT3-ITD微小残留病（MRD）缓解，并且诱导治疗结束时的MRD量与复发和生存相关。我们发现，FLT3-ITD插入突变的长度越长，预后越差，无论插入突变的长度如何，quizartinib都有益处，而且使用骨髓进行FLT3-ITD微小残留病（MRD）检测比使用外周血更敏感。

Regardless of the presence of NPM1 (nucleophosmin 1) comutation, quizartinib increased the rates of MRD negativity at the end of induction vs placebo.

无论NPM1（核仁磷酸蛋白1）共突变是否存在，quizartinib在诱导治疗结束时提高了微小残留病灶阴性率，与安慰剂相比。

Finally, comparison of the FLT3-ITD mutation length between the polymerase chain reaction (PCR) with capillary electrophoresis assay obtained at screening and the PCR next-generation sequencing MRD assay performed at the end of induction showed a 96.2% concordance with the exact ITD length.

最后，将筛选时通过聚合酶链反应结合毛细管电泳检测获得的FLT3-ITD突变长度与诱导治疗结束时进行的PCR下一代测序微小残留病灶检测结果进行比较，显示与确切的ITD长度有96.2%的一致性。

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。