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A Critical Review of Trials of First-Line BCR-ABL Inhibitor Treatment in Patients With Newly Diagnosed Chronic Myeloid Leukemia in Chronic Phase

机译：对新诊断的慢性粒细胞白血病慢性期患者一线BCR-ABL抑制剂治疗试验的批判性综述

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The characteristic expression of the constitutively active oncoprotein, BCR-ABL tyrosine kinase, in chronic myeloid leukemia (CML) was the basis for the development of BCR-ABL tyrosine kinase inhibitors for treatment. Three BCR-ABL inhibitors, imatinib, nilotinib, and dasatinib, have been approved by the US Food and Drug Administration for first-line treatment of patients with newly diagnosed CML in chronic phase (CML-CP). This article reviews the key phase III clinical trials supporting the use of first-line imatinib, nilotinib, and dasatinib in patients with CML-CP as well as findings of supportive phase II studies. At the time of its approval in 2001, imatinib induced unprecedented response rates in patients with CML-CP; however, resistance and intolerance to imatinib prevent 20% to 30% of patients from deriving full therapeutic benefit. Nilotinib and dasatinib, both approved in 2010 for first-line CML-CP treatment, are more potent than imatinib and less susceptible to imatinib resistance mechanisms. Comparative clinical trials of each agent with imatinib have shown that they are associated with significantly deeper and more rapid responses than standard-dose imatinib, without compromising safety. Given that evidence suggests achievement of an early response is predictive of improved long-term outcomes, earlier use of these compounds may lead to more rapid, deeper responses corresponding with improvements in patient outcome. Although future studies will benefit from more uniform definitions of endpoints and methods of analysis, data from published studies of first-line BCR-ABL inhibitor treatment for patients with newly diagnosed CML-CP support the use of either dasatinib or nilotinib in place of imatinib.
机译：组成性活性癌蛋白BCR-ABL酪氨酸激酶在慢性粒细胞白血病（CML）中的特征性表达是开发用于治疗的BCR-ABL酪氨酸激酶抑制剂的基础。三种BCR-ABL抑制剂伊马替尼，尼洛替尼和达沙替尼已被美国食品药品监督管理局批准用于一线治疗新诊断为慢性期CML的患者（CML-CP）。本文回顾了支持在CML-CP患者中使用一线伊马替尼，尼洛替尼和达沙替尼的关键III期临床试验，以及支持性II期研究的结果。在2001年获得批准时，伊马替尼在CML-CP患者中引起了空前的反应率。但是，对伊马替尼的耐药性和不耐受性会阻止20％至30％的患者获得完全的治疗益处。尼洛替尼和达沙替尼均于2010年获准用于一线CML-CP治疗，比伊马替尼更有效，对伊马替尼耐药机制更不敏感。每种药物与伊马替尼的比较临床试验表明，与标准剂量的伊马替尼相比，它们与更深，更快速的反应相关，而不会影响安全性。鉴于有证据表明早期反应的实现可预示长期结果的改善，因此，较早使用这些化合物可导致更快，更深的反应，从而改善患者的预后。尽管未来的研究将从终点和分析方法的更统一定义中受益，但已发表的针对新诊断为CML-CP的患者的一线BCR-ABL抑制剂治疗研究的数据支持使用达沙替尼或尼洛替尼代替伊马替尼。

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