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

作　　者：潘良琴[1] 刘为星[1] 朱雨[1] 洪鸣[1] 徐佳岱[1] 张苏江[1] 李建勇[1] 钱思轩[1] 

机构地区：[1]南京医科大学第一附属医院血液科,江苏南京210029

出　　处：《南京医科大学学报（自然科学版）》2015年第6期827-832,共6页Journal of Nanjing Medical University(Natural Sciences)

基　　金：国家自然科学基金(81070437;81270614;81300379)

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,CCy R）的比例分别为76.9%vs.52.9%、89.5%vs.70.0%、78.5%vs.77.3%,达CCy R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。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. （1）The 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 siignificantly 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.

关 键 词：慢性髓样白血病 尼洛替尼 伊马替尼 

分 类 号：R733.72[医药卫生—肿瘤]