Efficacy and safety of switching to nilotinib in patients with CML-CP in major molecular response to imatinib: results of a multicenter phase II trial (NILSw trial)
Efficacy and safety of switching to nilotinib in patients with CML-CP in major molecular response to imatinib: results of a multicenter phase II trial (NILSw trial)
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CML-CP 患者对伊马替尼主要分子反应中转用尼洛替尼的疗效和安全性：多中心 II 期试验（NILSw 试验）的结果
DOI：
10.1007/s12185-018-2401-y
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发表时间：
2018
影响因子：
2.1
通讯作者：
Kanakura Yuzuru
中科院分区：
文献类型：
--
作者：
Ishikawa Jun;Matsumura Itaru;Kawaguchi Tatsuya;Kuroda Junya;Nakamae Hirohisa;Miyamoto Toshihiro;Matsuoka Ken-ichi;Shibayama Hirohiko;Hino Masayuki;Hirase Chikara;Kamimura Tomohiko;Shimose Takayuki;Akashi Koichi;Kanakura Yuzuru
我们评估了在长期伊马替尼治疗后达到MMR且BCR-ABL 1转录水平持续可检测的CML-CP患者中转换为尼洛替尼的疗效和安全性。在伊马替尼治疗开始后> 18个月达到MMR但未达到深度分子学缓解（DMR）的患者接受尼洛替尼400 mg每日两次治疗，持续24个月。每3个月评估一次BCR-ABL 1转录水平。对38例中位年龄为57.5岁（范围22-76岁）的患者进行了评价。27例患者完成了24个月的尼洛替尼治疗; 11例患者因撤回知情同意（3例患者）、MMR丧失（1例）、不耐受（3例）或AE（5例）而停用尼洛替尼。20例患者[52.6%，（90%CI 38.2-66.7%）]实现了DMR。3、6、9、12、15、18和21个月时达到DMR的累积发生率分别为22.9、37.7、47.0、53.7、53.7、53.7和53.7%。不良事件与其他尼洛替尼研究中报告的一致。患者出现以下每种心血管并发症：房颤（G2）、胸闷和呼吸困难（G1）、心肌梗死（G2）和心力衰竭（G3）（每种并发症n= 1）。这项研究表明，尼洛替尼可对长期伊马替尼治疗后达到MMR的患者实现强效、快速的DMR诱导。
We evaluated the efficacy and safety of switching to nilotinib in CML-CP patients who had achieved MMR with continuous detectable BCR-ABL1 transcript levels after long-term imatinib treatment. Patients who had achieved MMR, but not deep molecular response (DMR), after > 18 months from the initiation of imatinib received nilotinib 400 mg twice daily for up to 24 months. BCR-ABL1 transcript levels were assessed every 3 months. Thirty-eight patients with a median age of 57.5 years (range 22–76 years) were evaluated. Twenty-seven patients completed 24 months of nilotinib treatment; 11 discontinued nilotinib due to retraction of consent (three patients), loss of MMR (1), intolerance (3) or AEs (5). Twenty patients [52.6%, (90% CI 38.2–66.7%)] achieved DMR. The cumulative incidence of achieving DMR by the time of 3, 6, 9, 12, 15, 18, and 21 months was 22.9, 37.7, 47.0, 53.7, 53.7, 53.7, and 53.7%, respectively. Adverse events were consistent with those reported in other nilotinib studies. Patients experienced each of the following cardiovascular complications: atrial fibrillation (G2), chest tightness and dyspnea (G1), myocardial infarction (G2) and heart failure (G3) (n= 1 for each complication). This study indicates nilotinib achieves strong, rapid induction of DMR for patients who achieved MMR after long-term imatinib therapy.
影响因子：
10.1
作者：
Etienne, Gabriel;Dulucq, Stephanie;Mahon, Francois-Xavier
通讯作者：
Mahon, Francois-Xavier