Nilotinib is effective in patients with chronic myeloid leukemia in chronic phase after imatinib resistance or intolerance: 24-month follow-up results.
Nilotinib is effective in patients with chronic myeloid leukemia in chronic phase after imatinib resistance or intolerance: 24-month follow-up results.
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DOI：
10.1182/blood-2010-03-277152
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发表时间：
2011-01-27
期刊：
影响因子：
20.3
通讯作者：
le Coutre, Philipp D
中科院分区：
文献类型：
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作者：
Kantarjian, Hagop M;Giles, Francis J;le Coutre, Philipp D
尼洛替尼是一种有效的BCR-ABL酪氨酸激酶选择性抑制剂，被批准用于新诊断的慢性粒细胞白血病慢性期(CML-CP)患者，以及伊马替尼失效后的CML-CP和CML加速期患者。尼洛替尼(每天两次，400毫克)是根据这项第二阶段开放标签研究的初步结果批准的。主要研究终点是患者获得主要细胞遗传学应答(CyR)的比例。所有患者均接受≥治疗24个月或早期停药。在321名患者中，124名(39%)继续接受尼洛替尼治疗。总体而言，59%的患者实现了主要的Cyr；44%的患者实现了完全性Cyr(CCyR)。在获得CCyR的患者中，56%的患者实现了主要的分子应答。周期反应是持久的，达到CCyR的患者中84%的患者在24个月内维持应答。24个月的总存活率为87%。不良反应多为轻度至中度，一般是短暂的，很容易控制。本研究表明尼洛替尼治疗慢性粒细胞白血病慢性粒细胞白血病疗效确切，安全性可控，并能为伊马替尼失效后的慢性粒细胞白血病慢性粒细胞白血病患者提供良好的长期疗效。
Nilotinib is a potent selective inhibitor of the BCR-ABL tyrosine kinase approved for use in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP), and in CML-CP and CML-accelerated phase after imatinib failure. Nilotinib (400 mg twice daily) was approved on the basis of the initial results of this phase 2 open-label study. The primary study endpoint was the proportion of patients achieving major cytogenetic response (CyR). All patients were followed for ≥ 24 months or discontinued early. Of 321 patients, 124 (39%) continue on nilotinib treatment. Overall, 59% of patients achieved major CyR; this was complete CyR (CCyR) in 44%. Of patients achieving CCyR, 56% achieved major molecular response. CyRs were durable, with 84% of patients who achieved CCyR maintaining response at 24 months. The overall survival at 24 months was 87%. Adverse events were mostly mild to moderate, generally transient, and easily managed. This study indicates that nilotinib is effective, with a manageable safety profile, and can provide favorable long-term benefits for patients with CML-CP after imatinib failure.