高三尖杉酯碱/奥曲肽琥珀酸酯：通往食品和药物管理局批准的漫长曲折之路。
Homoharringtonine/omacetaxine mepesuccinate: the long and winding road to food and drug administration approval.
机构信息
The University of Texas M.D. Anderson Cancer Center, Department of Leukemia, Houston, TX.
出版信息
Clin Lymphoma Myeloma Leuk. 2013 Oct;13(5):530-3. doi: 10.1016/j.clml.2013.03.017. Epub 2013 Jun 20.
Abstract
Homoharringtonine/omacetaxine is a unique agent with a long history of research development. It has been recently approved by the Food and Drug Administration for the treatment of chronic myeloid leukemia after failure of 2 or more tyrosine kinase inhibitors. Research with this agent has spanned over 40 years, with many instructive lessons to cancer research, which are summarized in this review.
摘要
高三尖杉酯碱/奥马环素是一种具有悠久研究开发历史的独特药物。最近，它已被美国食品和药物管理局批准用于治疗 2 种或以上酪氨酸激酶抑制剂治疗失败后的慢性髓性白血病。对该药物的研究已经跨越了 40 多年，为癌症研究提供了许多有益的经验教训，本综述对此进行了总结。
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Homoharringtonine-based induction regimens for patients with de-novo acute myeloid leukaemia: a multicentre, open-label, randomised, controlled phase 3 trial.基于高三尖杉酯碱的诱导方案治疗初发急性髓系白血病患者的多中心、开放标签、随机、对照 3 期临床试验。
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Phase 2 study of subcutaneous omacetaxine mepesuccinate after TKI failure in patients with chronic-phase CML with T315I mutation.T315I 突变的慢性期 CML 患者 TKI 治疗失败后皮下注射奥马曲星的 2 期研究。
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A phase II study of continuous infusion homoharringtonine and cytarabine in newly diagnosed patients with chronic myeloid leukemia: CALGB study 19804.一项关于持续输注高三尖杉酯碱和阿糖胞苷治疗新诊断慢性髓性白血病患者的II期研究：癌症和白血病B组研究19804
Cancer Chemother Pharmacol. 2009 Apr;63(5):859-64. doi: 10.1007/s00280-008-0805-8. Epub 2008 Aug 1.
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Interferon-alpha or homoharringtonine as salvage treatment for chronic myeloid leukemia patients who acquire the T315I BCR-ABL mutation.干扰素-α或高三尖杉酯碱作为获得T315I BCR-ABL突变的慢性髓性白血病患者的挽救治疗。
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