Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial.
Long-term benefits and risks of frontline nilotinib vs imatinib for chronic myeloid leukemia in chronic phase: 5-year update of the randomized ENESTnd trial.
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慢性阶段的慢性髓样白血病的前线尼洛替尼与伊马替尼的长期益处和风险：随机ENESTND试验的5年更新。
DOI：
10.1038/leu.2016.5
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发表时间：
2016-05
期刊：
影响因子：
11.4
通讯作者：
Kantarjian HM
中科院分区：
文献类型：
--
作者：
Hochhaus A;Saglio G;Hughes TP;Larson RA;Kim DW;Issaragrisil S;le Coutre PD;Etienne G;Dorlhiac-Llacer PE;Clark RE;Flinn IW;Nakamae H;Donohue B;Deng W;Dalal D;Menssen HD;Kantarjian HM
在临床试验中评价尼洛替尼疗效和安全性的III期-新诊断患者（ENESTnd）研究中，尼洛替尼在新诊断的慢性髓性白血病慢性期（CML-CP）患者中的缓解率比伊马替尼更早、更高，进展至加速期/急变期（AP/BC）的风险更低。在此，在至少5年的随访后，对ENESTnd患者的长期结局进行了评估。5年时，尼洛替尼组（300 mg每日两次，54%和400 mg每日两次，52%）超过一半的患者达到分子学缓解4.5（MR 4.5;国际量表BCR-ABL <0.0032%），而伊马替尼组为31%。在所有索卡尔风险组中均观察到尼洛替尼获益。总体而言，安全性结果与既往报告一致。接受尼洛替尼治疗的患者发生的心血管事件（CVEs）数量多于伊马替尼，尼洛替尼组的血胆固醇和葡萄糖水平升高也更常见。与CML进展相关的高死亡率相反，任何组中与CVE、感染或肺部疾病相关的死亡很少。这些长期结果支持尼洛替尼300 mg每日两次一线治疗CML-CP患者的积极获益-风险特征。
In the phase 3 Evaluating Nilotinib Efficacy and Safety in Clinical Trials–Newly Diagnosed Patients (ENESTnd) study, nilotinib resulted in earlier and higher response rates and a lower risk of progression to accelerated phase/blast crisis (AP/BC) than imatinib in patients with newly diagnosed chronic myeloid leukemia in chronic phase (CML-CP). Here, patients' long-term outcomes in ENESTnd are evaluated after a minimum follow-up of 5 years. By 5 years, more than half of all patients in each nilotinib arm (300 mg twice daily, 54% 400 mg twice daily, 52%) achieved a molecular response 4.5 (MR4.5; BCR-ABL⩽0.0032% on the International Scale) compared with 31% of patients in the imatinib arm. A benefit of nilotinib was observed across all Sokal risk groups. Overall, safety results remained consistent with those from previous reports. Numerically more cardiovascular events (CVEs) occurred in patients receiving nilotinib vs imatinib, and elevations in blood cholesterol and glucose levels were also more frequent with nilotinib. In contrast to the high mortality rate associated with CML progression, few deaths in any arm were associated with CVEs, infections or pulmonary diseases. These long-term results support the positive benefit-risk profile of frontline nilotinib 300 mg twice daily in patients with CML-CP.