【摘要】 目的:观察CLAT方案治疗难治性急性髓系白血病(R-AML)的疗效及不良反应。方法:2013年6月至2015年10月期间,广东省人民医院采用CLAT方案治疗R-AML患者18例,中位年龄37岁(18-58)岁;男性16例,女性2例。CLAT方案:克拉屈滨(Cla)5 mg/(m~2·d),d 1-5;阿糖胞苷(Ara-C)1.0 g/(m~2·d),d 1-5;拓扑替康(Top)1.25 mg/(m~2·d),d 1-5;粒细胞集落刺激因(G-CSF)300μg/d,第6天直至中性粒细胞(ANC)>1.0×10~9/L。结果:18例患者中2例因早期死亡未进行疗效评估,可评估疗效的16例患者。10例(55.6%)获得完全缓解(CR),2例(11.1%)部分缓解(PR),总有效率(OR)66.7%(12/18),4例(22.2%)未缓解(NR)。CLAT化疗后,所有患者均出现重度骨髓抑制,ANC<0.5×10~9/L的中位持续时间为13(2-21)d,血小板<20×10~9/L中位持续时间为12(2-21)d,感染发生率为100%,2例因感染早期死亡,16例患者发生Ⅱ-Ⅳ级感染,均能获得有效控制。主要非血液学毒性为Ⅰ-Ⅱ度恶心、呕吐、腹泻、皮疹,经对症支持治疗后好转。CR患者预期平均OS为11.6±2.5个月(95%CI:6.7-16.64),中位OS为9.5个月;预期平均DFS为11.4±2.7个月(95%CI:6.1-16.7),中位DFS为9.5个月;CR患者预期1年OS和DFS分别为45%和46.9%。结论:CLAT方案治疗难治性急性髓系白血病有效,患者耐受性良好,可作为桥接移植的挽救治疗方案,并为不适合使用蒽环类药物化疗的难治患者提供了新选择。更多还原

【Abstract】 Objective:To explore the clinical efficacy and toxicity of CLAT protocol(cladribine,cytarabine and topotecan) for treating patients with refractory acute myeloid leukemia(R-AML).Methods:A total of 18 patients with R-AML(median age 37 years,range 18 to 58 years;male n = 16,female n = 2) were treated with CLAT protocol,which consisted of cladribine 5 mg/m~2/d,i.v.on days 1-5,cytarabine 1.5 g/m~2/d,i.v.on days 1-5,topotecan1.25 mg/m~/d,i.v.on days 1-5 and G-CSF 300 μg/d subcutaneous injection on day 6 until neutrophile granulocyte recovery.Results:Out of 18 patients 2 died of severe infection before the assessment.Among 16 evaluated patients,10(55.6%) achieved complete remission(CR),and 2(11.1%) achieved partial remission(PR),the overall response rate was 66.7%,the rest 4 patients did not respond(NR).The median overall survival time and DFS for the CR patients was 9.5 months(95%CI:6.7- 16.64) and 9.5 months(95%CI:6.1- 16.7) respectively.The 1 year OS and DFS rates were 45%and 46.9%,respectively.All patients developed grade 4 of granulocytopenia and thrombocytopenia,the median duration was 13(range 2 to 21) days and 12 days(range 2 to 21),respectively,all patients developed infection,2 patients died of severe infection.The most common non-hematological side effects included nausea,vomiting,diarrhoea,rash,aminotransferase or bilirubin elevation and were grade 1 to 2.Conclusion:The CLAT protocol seems to have promising for the treatment of refractory AML patients,and patients well tolerated.This CLAT protocol offers an alternative treatment for R-AML patients who received severe intensive treatment,especially with anthracycline-containing chemotherapy.更多还原