Nilotinib vs. imatinib in Japanese patients with newly diagnosed chronic myeloid leukemia in chronic phase: long-term follow-up of the Japanese subgroup of the randomized ENESTnd trial
Nilotinib vs. imatinib in Japanese patients with newly diagnosed chronic myeloid leukemia in chronic phase: long-term follow-up of the Japanese subgroup of the randomized ENESTnd trial
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DOI：
10.1007/s12185-017-2353-7
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发表时间：
2018-03-01
影响因子：
2.1
通讯作者：
Shibayama, Hirohiko
中科院分区：
文献类型：
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作者：
Nakamae, Hirohisa;Fukuda, Tetsuya;Shibayama, Hirohiko
在正在进行的国际III期研究中，评价尼洛替尼在临床试验中的疗效和安全性-新诊断患者（ENESTnd），比较尼洛替尼300 mg和尼洛替尼400 mg每日两次与伊马替尼400 mg每日一次治疗新诊断的慢性期慢性髓性白血病（CML-CP）。ENESTnd（n = 846）总体人群的结果显示，尼洛替尼的缓解率高于伊马替尼，且耐受性良好。ENESTnd中日本患者的结局在1年随访后进行了专门分析，并显示出与总体人群相似的趋势;我们根据5年随访对日本亚组进行了更新分析。在尼洛替尼300 mg（n = 29）、尼洛替尼400 mg（n = 23）和伊马替尼（n = 25）组的日本患者中，分别有86.2%、78.3%和60.0%的患者达到主要分子学缓解[BCR-ABL 1
In the ongoing, international, phase 3 study Evaluating Nilotinib Efficacy and Safety in Clinical Trials-Newly Diagnosed Patients (ENESTnd), nilotinib 300 and nilotinib 400 mg, both twice daily, are compared with imatinib 400 mg once daily for the treatment of newly diagnosed chronic myeloid leukemia in the chronic phase (CML-CP). Results for the overall population in ENESTnd (n = 846) showed that nilotinib resulted in higher response rates vs. imatinib and was well tolerated. Outcomes among Japanese patients in ENESTnd were specifically analyzed after 1 year of follow-up, and showed similar trends to the overall population; we present updated analysis of the Japanese subgroup based on 5 years of follow-up. Among Japanese patients in the nilotinib 300-mg (n = 29), nilotinib 400-mg (n = 23), and imatinib (n = 25) arms, 86.2, 78.3, and 60.0%, respectively, achieved major molecular response [BCR-ABL1