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（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.
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 .
出处
《中华内科杂志》
CAS
CSCD
北大核心
2017年第11期810-815,共6页
Chinese Journal of Internal Medicine
