AZA联合HHT和LDAC治疗3+7常规方案不耐受的急性髓系白血病患者的疗效和安全性

Efficacy and safety of AZA combined with HHT and LDAC in the treatment of acute myeloid leukemia patients with 3+7 conventional regimen intolerance

目的评估阿扎胞苷(AZA)联合高三尖杉酯碱(HHT)和低剂量阿糖胞苷(LDAC)治疗3+7常规方案不耐受的急性髓系白血病(AML)患者的有效性和安全性。方法回顾性分析中南大学湘雅二医院收治的33例AML患者(15例初治患者和18例复发/难治性患者)的临床特征、疗效、预后及不良反应事件。结果33例接受AZA+HHT+LDAC方案治疗的AML患者中,中位年龄为55岁,9例患者的细胞遗传学风险为中危,18例患者的细胞遗传学风险为高危。33例患者中,3例失访、1例资料不全,余29例接受AZA+HHT+LDAC治疗的患者中,总完全缓解(CR)率为69.0%(20/29),总应答率(ORR)为79.3%(23/29);中位无进展生存期(PFS)为7.0个月。在亚组分析中:包括年龄、性别、美国东部肿瘤协作组(ECOG)评分、疾病分类、骨髓原始细胞、外周血白细胞、危险度分层、表观遗传学异常亚组中,仅不同ECOG评分组的CR率和PFS差异有统计学意义(P=0.048;P=0.021)。29例患者共接受69个AZA+HHT+LDAC化疗周期。根据不良事件的常见毒性标准对69个周期进行回顾性分级(CTC AE 5.0版)。最常见的Ⅲ~Ⅳ级血液学不良事件是血小板减少症(54/69,78.3%)、粒细胞缺乏症(48/69,69.6%),常见的非血液学不良事件包括恶心(19/69,27.5%)、感染(17/69,24.6%)和低钾血症(18/69,26.1%)。结论AZA联合HHT和LDAC在急性髓系白血病治疗中有较好的疗效,不良反应事件可控。

Objective To evaluate the efficacy and safety of azacytidine(AZA)combined with homoharringtonine(HHT)and low-dose cytarabine(LDAC)in the treatment of acute myeloid leukemia(AML)patients with 3+7 conventional regimen intolerance.Methods A retrospective analysis was conducted on the clinical characteristics,efficacy,prognosis,and adverse events of 33 AML patients(15 initially diagnosed and 18 relapsed/refractory)admitted to the Second Xiangya Hospital of Central South University.Results Among the 33 AML patients treated with this regimen,the median age was 55 years old,9 patients had a moderate cytogenetic risk,and 18 patients had a high cytogenetic risk.Among the 33 patients,3 were lost to follow-up and 1 had incomplete data.Among the remaining 29 patients who received AZA+HHT+LDAC treatment,the total complete response(CR)rate was 69.0%(20/29),and the total response rate(ORR)was 79.3%(23/29);The median progression free survival(PFS)was 7.0 months.Among the subgroup analysis,including age,gender,Eastern Cooperative Oncology Group(ECOG)score,disease classification,bone marrow progenitor cells,peripheral blood leukocytes,risk stratification,and epigenetic abnormalities,only CR rates and PFS differences were statistically significant among different ECOG scoring groups(P=0.048;P=0.021).A total of 29 patients underwent 69 AZA+HHT+LDAC chemotherapy cycles.Retrospective grading was performed on 69 cycles based on common toxicity criteria for adverse events(CTC AE version 5.0).The most common gradeⅢ-Ⅳhematological adverse events were thrombocytopenia(54/69,78.3%)and granulocytopenia(48/69,69.6%).Common non hematological adverse events included nausea(19/69,27.5%),infection(17/69,24.6%),and hypokalemia(18/69,26.1%).Conclusions AZA combined with HHT and LDAC has a good therapeutic effect in the treatment of acute myeloid leukemia,and adverse reaction events are controllable.