伊马替尼或尼洛替尼一线治疗老年慢性髓系白血病慢性期患者疗效及安全性分析

Efficacy and safety of imatinib versus nilotinib in elderly patients with chronic phase of chronic myeloid leukemia

目的:探讨伊马替尼(imatinib,IM)或尼洛替尼(nilotinib,NIL)治疗老年慢性髓系白血病(chronic myeloid leukemia,CML)患者的疗效和安全性。方法:回顾分析75例一线使用IM或NIL年龄≥60岁的CML患者,IM组43例,NIL组32例,比较两组患者的疗效及安全性。结果:IM组和NIL组间3、6、9、12个月主要分子学反应(major molecular response,MMR)(分别为23.07%vs. 15.00%,52.38%vs. 52.38%,57.89%vs. 59.09%,54.17%vs. 57.14%)及MR4.(0分别为11.53%vs. 10.00%,52.38%vs.47.62%,57.89%vs. 50.00%,54.17%vs. 42.86%)无统计学差异(P<0.05);3、6、12、18个月最佳反应率无统计学差异(分别为60.47%vs. 75.00%,60.47%vs. 71.88%,62.79%vs. 75.00%,72.09%vs. 90.63%,P>0.05);总生存(overall survival,OS)、无进展生存(progression-free survival,PFS)及无事件生存(event-free survival,EFS)期无统计学差异(90.70%vs. 93.75%,79.07%vs.90.62%,34.88%vs. 65.63%,P>0.05);NIL组较IM组治疗失败率低(15.63%vs. 44.19%,P=0.009),但更易发生血液学或心血管不良事件(Adverse Event,AE)(31.25%vs. 6.78%,P=0.006)。结论:IM或NIL一线治疗老年CML均获得良好疗效,NIL治疗失败率低于IM,但NIL较IM更易出现血液学或心血管不良反应。

Objective:This study aims to explore the efficacy and safety of imatinib(IM)or nilotinib(NIL)as the first-line treatment in elderly chronic phase of chronic myeloid leukemia(CML-CP).Methods:A retrospective analysis of 75 elderly CML patients receiving IM or NIL as first-line treatment.The clinical efficacy and safety indexes were compared between IM(43 cases)and NIL(32 cases)group.Results:No difference was found between the two groups when comparing 3 month-,6 month-,9 month-and 12 monthmajor molecular response(MMR)(23.07%vs.15.00%,52.38%vs.52.38%,57.89%vs.59.09%,54.17%vs.57.14%,P>0.05)and MR4.0(11.53%vs.10.00%,52.38%vs.47.62%,57.89%vs.50.00%,54.17%vs.42.86%,P>0.05).There was no significantly difference of 3 month-,6 month-,12 month-and 18 month-optimal response between the two groups(60.47%vs.75.00%,60.47%vs.71.88%,62.79%vs.75.00%,72.09%vs.90.63%,P>0.05),as well as overall survival(OS),progression-free survival(PFS)and eventfree survival(EFS)during the therapies(90.70%vs.93.75%,79.07%vs.90.62%,34.88%vs.65.63%,P>0.05).More failure happened in IM group(15.63%vs.44.19%,P=0.009).More cardiovascular or hematologic adverse events(AEs)happened in NIL group(31.25%vs.6.78%,P=0.006).Conclusion:No difference was found between IM and NIL when comparing molecular response and optimal response.Less failure but more cardiovascular or hematologic AEs happened in NIL group.