酪氨酸激酶抑制剂治疗慢性期老年人慢性粒细胞白血病的疗效及安全性分析

目的 回顾性分析酪氨酸激酶抑制剂(TKI)治疗慢性期慢性粒细胞白血病(CML)老年患者的疗效及安全性.方法 收集2005年1月至2016年1月于华西医院血液内科就诊的发病年龄≥60岁且接受TKI治疗的慢性期CML老年患者共计52例作为研究对象.其中,33例患者的一线治疗方案选择伊马替尼(IM)治疗,2例患者一线治疗方案选择二代TKI尼洛替尼(NIL)治疗,其余17例患者接受IM治疗前经过干扰素治疗.对其治疗反应、总体生存(OS)、无事件生存(EFS)、伴随疾病情况及药物不良反应进行回顾性分析,总结TKI治疗老年CML的疗效及安全性.结果 ①随访结束时,所有患者累积完全血液学缓解(CHR)、主要细胞遗传学缓解(MCyR)、完全细胞遗传学缓解(CCyR)和主要分子学缓解(MMR)率分别为100.0％(52/52)、82.7％(43/52)、80.8％(42/52)和71.2％(37/52).所有患者1、5和10年OS率分别为100.0％、95.1％和75.3％,EFS率分别为92.3％、73.3％和51.4％.②25例患者诊断为CML时存在伴随疾病,所有52例患者查尔森合并症指数(CCI)评分均≤2分.32例CCI评分=0分与20例CCI评分＞0分的患者相比,累积CCyR、MCyR、MMR率,以及Ⅲ～Ⅳ级血液学与非血液学不良反应发生率差异均无统计学意义(x2 =0.948、0.525、0.021、0.288、0.519,P＞0.05).③50例接受IM治疗患者中,Ⅲ～Ⅳ级中性粒细胞减少、血小板减少、贫血发生率分别为16.0％(8/50)、28.0％ (14/50)及18.0％(9/50),Ⅲ～Ⅳ级非血液学不良反应发生率为28.0％(14/50),5例(10.0％,5/50)患者因为IM不耐受而选择二代TKI治疗.结论 TKI对慢性期CML老年患者具有良好的疗效及安全性,轻微的伴随疾病不影响疾病治疗.

Efficacy and safety of tyrosine kinase inhibitor in treating elderly patients with chronic myeloid leukemia during chronic phrase

Objective To evaluate the efficacy and safety of tyrosine kinase inhibitors (TKI) in treating the elderly patients with chronic myeloid leukemia (CML) during chronic phrase.Methods From January 2015 to January 2016,a total of 52 cases of chronic phrase CML patients who received TKI treatment,over 60-year-old and were treated at Department of Hematology,West China Hospital were included in this study.Thirty-three eases of them chose imatinib (IM) as the first-line treatment regimen and 2 cases of them chose nilotinib (NIL) as the first-line treatment regimen,while the other 17 cases were treated with interferon before IM.The therapeutic response,overall survival (OS),event-free survival (EFS),comorbidity and drug-related adverse reactions of all the patients were analyzed by retrospective method,in order to summarize the efficacy and safety of TKI in the treatment of CML in elderly patients.Results ① The rates of cumulative complete hematologic response (CHR),major cytogenetic response (MCyR),complete cytogenetic response (CCyR) and major molecular response (MMR) were 100.0％ (52/ 52),82.7 ％ (43/52),80.8 ％ (42/52) and 71.2 ％ (37/52),respectively.The rates of OS of 1-year,5-year and 10-year were 100.0％,95.1 ％ and 75.3％,respectively,while the rates of EFS of 1-year,5-year and 10-year were 92.3％,73.3％ and 51.4％,respectively.② Twenty-five patients had comorbidities.The scores of Charlson comorbidity index (CCI) of these 52 patients were all less than 2 scores.There were no significant differences in the incidence of cumulative CCyR,MCyR,MMR,grade Ⅲ hematologic and non-hematologic adverse reactions between 32 patients with CCI score=0 and 20 patients with CCI score＞ 0 (x2 =0.948,0.525,0.021,0.288,0.021;P＞0.05).③ In 50 patients who received treatment of IM,the incidence rates of Ⅲ-Ⅳ grade neutropenia,thrombocytopenia and anemia were 16.0 ％ (8/50),28.0％ (14/50) and 18.0％ (9/50),respectively.While 14 patients occurred Ⅲ-Ⅳ grade non-hematologic adverse reactions,with the incidence rate of 28.0％ (14/50).Due to intolerance of IM,5 cases (10.0％,5/50) of the patients received the second-line TKI treatment.Conclusions TKI is an effective and safe treatment for the elderly patients who have chronic phrase CML.Mild comorbidities have no influence on the therapy.