二代酪氨酸激酶抑制剂一线二线治疗慢性髓细胞白血病的临床研究

目的:探讨二代络氨酸激酶抑制剂治疗慢性髓细胞白血病(CML)的临床疗效.方法:选择2013年1月至2016年12月收治的64例CML患者为研究对象,均接受二代络氨酸激酶抑制剂(TKI)治疗,其中尼洛替尼用药41例,达沙替尼用药23例;二代TKI中一线用药13例,二线用药51例,随访6~54个月,中位随访18个月;观察整体完全血液学缓解(CHR)率、CCyR率、主要细胞遗传学缓解(MCyR)率、MMR率及随访总生存率(OS)、无事件生存率(EFS);同时比较一线、二线治疗反应及药物不良反应情况.结果:随访截止时继续二代TKI治疗43例,死亡14例,停药2例,失访2例,更改用药方案3例;整体治疗反应:CHR率98.44%,MCyR率64.06%,CCyR率59.37%,MMR率43.75%;整体生存情况:患者OS、EFS均随病程延长而下降.一线治疗CCyR率、MCyR率、MMR率均明显高于二线治疗(P<0.05);尼洛替尼、达沙替尼用药不良反应发生率比较无显著差异(P>0.05).结论:尼洛替尼、达沙替尼二代TKI治疗慢性髓细胞白血病疗效明确,预后良好,安全性较好;二代TKI一线治疗CML相比二线治疗效果更显著.

Clinical Study on Second-generation Tyrosine Kinase Inhibitors in the First-line and Second-line Treatment of Chronic Myeloid Leukemia

Objective:To investigate the clinical effect of second-generation tyrosine kinase inhibitors in the treatment of chronic myeloid leukemia ( CML) . Methods:A total of 64 patients with CML treated between January 2013 and December 2016 were selected as study subjects and treated with second-generation tyrosinekinase inhibitor ( TKI) . Among them,there were 41 cases treated with Nilotinib and 23 cases with Dasatinib. In patients treated by TKI,there were 13 cases receiving first-line medication and 51 cases receiving second-line medication. All were followed up for 6 ~ 54 months,median 18 months. The overall complete hematologic remission ( CHR) rate,CCyR rate,rate of major cytogenetic response ( MCyR),MMR rate,follow-up over-all survival rate ( OS) and event free survival rate ( EFS) were observed;Meanwhile,the responses of first-line and second-line treatment and adverse drug reactions were compared. Results:At the end of follow-up,43 cases continued second-generation TKI treatment, 14 cases died, 2 cases stopped medication, 2 cases were lost to follow up and 3 cases changed the medication regimen;In terms of overall responses to treatment,the rates of CHR, MCyR, CCyR and MMR were 98. 44%, 64. 00%, 59. 37% and 43. 75% respectively; In terms of overall survival status,OS and EFS decreased with duration of the disease. The rates of CCyR,MCyR and MMR of first-line treatment were significantly higher than the second-line treatment ( P < 0.05);There were no significant differences in the incidence of adverse drug reactions between Nilotinib and Dasatinib ( P >0.05) . Conclusion:The effect of Nilotinib and Dasatinib second-generation TKI in the treatment of CML is clear. The prognosis is good and safety is better; The effect of second generation TKI first-line treatment is better than second-line treatment in treating CML.