Quizartinib versus salvage chemotherapy in relapsed or refractory FLT3-ITD acute myeloid leukaemia (QuANTUM-R): a multicentre, randomised, controlled, open-label, phase 3 trial

Quizartinib versus salvage chemotherapy in relapsed or refractory FLT3-ITD acute myeloid leukaemia (QuANTUM-R): a multicentre, randomised, controlled, open-label, phase 3 trial
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DOI:
10.1016/s1470-2045(19)30150-0
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发表时间:
2019-07-01
期刊:
影响因子:
51.1
通讯作者:
Levis, Mark J.
Levis, Mark J.
中科院分区:
医学1区
文献类型:
--
作者:
Cortes, Jorge E.;Khaled, Samer;Levis, Mark J.

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复发性或难治性FLT 3内部串联重复(FLT 3-ITD)阳性急性髓系白血病患者的预后较差,包括复发频率高,对挽救治疗的反应较差,总生存期较FLT 3野生型疾病患者短。我们的目的是评估是否单药quizartinib,口服,高效和选择性的II型FLT 3抑制剂,提高总生存率与挽救chemotherapy.Methods量子-R是一个随机,对照,3期试验在152家医院和癌症中心在19个国家。年龄≥ 18岁、ECOG体能状态评分为0-2且复发性或难治性(首次复合完全缓解持续时间)的合格患者
Background Patients with relapsed or refractory FLT3 internal tandem duplication (FLT3-ITD)-positive acute myeloid leukaemia have a poor prognosis, including high frequency of relapse, poorer response to salvage therapy, and shorter overall survival than those with FLT3 wild-type disease. We aimed to assess whether single-agent quizartinib, an oral, highly potent and selective type II FLT3 inhibitor, improves overall survival versus salvage chemotherapy.Methods QuANTUM-R is a randomised, controlled, phase 3 trial done at 152 hospitals and cancer centres in 19 countries. Eligible patients aged 18 years or older with ECOG performance status 0-2 with relapsed or refractory (duration of first composite complete remission