[The clinical analysis of frontline nilotinib vs imatinib therapies for newly diagnosed chronic myeloid leukemia in chronic phase].

Objective: To compare the clinical efficacy and safety of nilotinib and imatinib as frontline therapy in newly diagnosed patients with chronic myeloid leukemia in chronic phase(CML-CP). Methods: Until December 31st 2016, 18 patients using nilotinib and 83 using imatinib were recruited in our study. The efficacy and safety of two groups were evaluated. Results: A total of 101 patients with CML-CP included 18 receiving nilotinib and 83 imatinib. The optimal response rates at 3, 6, 12 and 18 months in nilotinib and imatinib group were 88.9% (16/18) vs 57.3% (47/82) (P=0.012), 82.4% (14/17) vs 55.7% (44/79) (P=0.041), 9/12 vs 63.9% (39/61) (P=0.460), 6/9 vs 68.9% (31/45) (P=0.896) respectively. The optimal response rates by 3 months in low sokal risk group on nilotinib and imatinib were 9/9 vs 76.5%(26/34) (P=0.107), in intermediate and high sokal risk group were 7/8 vs 45.2%(14/31) (P=0.032). At the end of follow-up, the rate of major molecular response (MMR) in nilotinib group was 72.2%, which was higher than 56.6% in imatinib group (P=0.021). The rate of complete cytogenetic response (CCyR) in nilotinib group was 100%, which was higher than 71.1% in imatinib group (P = 0.002). Progression free survival (PFS) rates in nilotinib and imatinib groups were 94.4% and 98.8% (P=0.019) respectively; whereas event free survival (EFS) rates were 88.9% and 48.2% (P=0.045). The incidence of drug related adverse reactions in nilotinib and imatinib was similar with only minor proportion of grade 3/4 adverse reactions. Conclusions: Nilotinib achieves a deeper molecular response in a shorter time than imatinib in newly diagnosed patients with CML-CP, especially in patients with high risk outcome. Good safety is obtained in both groups so as to ensure a long-term administration and improving prognosis.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(CML)慢性期患者的临床疗效和用药安全性。 方法： 收集18例接受一线尼洛替尼治疗和83例一线伊马替尼治疗的初诊CML慢性期患者的病例资料，比较分析两组患者的临床疗效及用药安全性。 结果： 101例初诊CML慢性期患者3个月获得Bcr－Abl国际标准化比值(IS)≤10%或费城染色体阳性(Ph(＋))≤35%的比例在尼洛替尼组为88.9%(16/18)，显著高于伊马替尼组的57.3%(47/82)，P＝0.012；6个月获得Bcr－Abl IS<1%或Ph(－)的比例在尼洛替尼组为82.4%(14/17)，显著高于伊马替尼组的55.7%(44/79)，P＝0.041；12个月Bcr－Abl IS<0.1%的比例在尼洛替尼组为9/12，高于伊马替尼组的63.9%(39/61)，P＝0.460；18个月Bcr－Abl IS<0.1%的比例在尼洛替尼组为6/9，伊马替尼组为68.9%(31/45)，P＝0.896。Sokal评分低危组、中高危组患者3个月达到治疗最佳反应的比例在尼洛替尼组和伊马替尼组分别为9/9比76.5%(26/34)(P＝0.107)和7/8比45.2%(14/31)(P＝0.032)。截止到末次随访日期2016年12月31日，尼洛替尼组主要分子学反应(MMR)的累积发生率为72.2%，显著高于伊马替尼组的56.6%(P＝0.021)；尼洛替尼组完全细胞遗传学反应(CCyR)的累积发生率为100%，显著高于伊马替尼组的71.1%(P＝0.002)。尼洛替尼组和伊马替尼组的无进展生存率分别为94.4%和98.8%(P＝0.019)，无事件生存率分别为88.9%和48.2%(P＝0.045)。尼洛替尼和伊马替尼组治疗相关的不良反应发生率相当，3～4级不良反应发生率少，显示出两组均有良好的安全性。 结论： 尼洛替尼治疗初诊的CML慢性期患者较伊马替尼可更早达到深层次的分子学缓解，特别是对于预后评估风险高的患者，且有良好的安全性，从而获得更好的远期预后。.