Efficacy and safety of imatinib versus nilotinib in elderly patients with chronic phase of chronic myeloid leukemia
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摘要:
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。
Abstract:
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 month- major 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 event-free 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.