文章摘要
潘良琴,刘为星,朱 雨,洪 鸣,徐佳岱,张苏江,李建勇,钱思轩.尼洛替尼和伊马替尼一线治疗慢性髓性白血病的疗效及安全性观察[J].南京医科大学学报,2015,(6):827~832
尼洛替尼和伊马替尼一线治疗慢性髓性白血病的疗效及安全性观察
Efficacy and safety of nilotinib and imatinib in chronic myeloid leukemia as first-line treatment
投稿时间:2015-01-12  
DOI:10.7655/NYDXBNS20150613
中文关键词: 慢性髓样白血病  尼洛替尼  伊马替尼
英文关键词: chronic myeloid leukemia  nilotinib  imatinib
基金项目:国家自然科学基金(81070437,81270614,81300379)
作者单位
潘良琴 南京医科大学第一附属医院血液科,江苏 南京 210029 
刘为星 南京医科大学第一附属医院血液科,江苏 南京 210029 
朱 雨 南京医科大学第一附属医院血液科,江苏 南京 210029 
洪 鸣 南京医科大学第一附属医院血液科,江苏 南京 210029 
徐佳岱 南京医科大学第一附属医院血液科,江苏 南京 210029 
张苏江 南京医科大学第一附属医院血液科,江苏 南京 210029 
李建勇 南京医科大学第一附属医院血液科,江苏 南京 210029 
钱思轩 南京医科大学第一附属医院血液科,江苏 南京 210029 
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中文摘要:
      目的:比较尼洛替尼和伊马替尼一线治疗初诊慢性髓性白血病(chronic myeloid leukemia,CML)慢性期(chronic phase,CP)患者的疗效和安全性。方法:65例新诊断的CML-CP患者,接受口服尼洛替尼300~400 mg,每日2次(尼洛替尼组)或口服伊马替尼400 mg,每日1次(伊马替尼组)治疗,比较两组患者的疗效及安全性。结果:65例初发CML-CP患者,确诊CML的中位时间均为19.5(5~39)个月。尼洛替尼组26例,伊马替尼组39例,治疗后3?6?12个月时尼洛替尼组主要分子学反应(major mdecular response,MMR)获得率高于伊马替尼组,分别为23.1% vs. 7.6%?45.5% vs. 21.2%?66.7% vs. 54.8%,且在6个月时有显著差异。Sokal积分低?中和高危组患者12个月MMR的获得率在尼洛替尼组和伊马替尼组分别为81.3% vs. 42.8%?42.8% vs. 57.1%?66.7% vs. 50.0%。3个月获得Bcr-Abl ≤ 10%的发生率在尼洛替尼组为80.8%,显著高于伊马替尼组的41.0%;6个月达Bcr-Abl<1%的比例在尼洛替尼组为77.3%,高于伊马替尼组的48.5%,均有显著差异。12个月Bcr-Abl<0.1%的比例在尼洛替尼组为66.7%,高于伊马替尼组的54.8%,尼洛替尼组达MMR的中位时间短于伊马替尼组(14 vs. 34个月)。尼洛替尼组和伊马替尼组3?6和12个月获得细胞遗传学缓解(complete cytogenetic rewsponse,CCyR)的比例分别为76.9% vs.52.9%?89.5% vs. 70.0%?78.5% vs. 77.3%,达CCyR的中位时间分别为3个月和 6个月。尼洛替尼和伊马替尼组治疗相关的不良反应多为1~2级,患者大多可耐受。结论:尼洛替尼治疗初诊CML-CP较伊马替尼更早达到分子学缓解,安全有效,有可能作为一线用药。
英文摘要:
      Objective:To evaluate the efficacy and safety of nilotinib and imatinib in patients with newly diagnosed chronic phase chronic myeloid leukemia (CML-CP). Methods: A total of 65 CML-CP patients received nilotinib 600~800 mg orally twice daily or imatinib 400 mg orally once daily. Data on curative efficacy and tolerance were collected and compared. Results:Of 65 CML-CP patients, 26 patients received nilotinib and 39 received imatinib. The both median duration of therapy and follow-up were 19.5 (5~39) months. ①The rates of major molecular response (MMR) at 3,6,12 months were higher in nilotinib group than those in imatinib group(23.1% vs. 7.6%, 45.5% vs. 22.2%, 66.7% vs. 54.8%, respectively). There was significantly statistic significance between two groups at 6 months. MMR rates by 12 months in low, intermediate and high sokal risk groups on nilotinib and imatinib were 81.3% vs. 42.8%,42.8% vs. 57.1%,66.7% vs. 50%, respectively. The rates of Bcr-Abl ≤ 10% at 3 months, <1% at 6 months and <0.1% at 12 months were higer in the nilotinib group than those in the imatinib group (80.8% vs. 41%, P=0.002, 77.3% vs. 48.5%,P=0.033 and 66.7% vs. 54.8%, P=0.394). The median time to MMR was significantly shorter for nilotinib than that for imatinib (14 months vs 34 months). The rate of complete cytogenetic response (CCyR) at 3, 6 and 12 months in the nilotinib and the imatinib group were 76.9% vs. 52.9%, 89.5% vs. 70% and 78.5% vs. 77.3%, respectively. The median time to CCyR was 3 months in imatinib group and 6 months in nilotinib group. ② The drug related adverse events were mostly grade 1/2 and were well tolerated by most of the patients. Conclusion:Nilotinib can reach molecular response in a shorter time than imatinib and also has a confirmed efficacy and tolerability in newly diagnosed CML-CP patients and can be used as first-line therapy.
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