FA方案巩固强化治疗急性髓系白血病的临床观察

Primary clinical study of FA regimen as consolidation therapy for patients with acute myeloid leukemia

目的探讨氟达拉滨联合中剂量阿糖胞苷即FA方案巩固强化治疗急性髓系白血病(acute myeloidleukemia,AML)的临床疗效及副作用。方法观察组28例AML患者采用FA方案进行巩固强化治疗,氟达拉滨30 mg/m2(1～3 d),静脉滴注,阿糖胞苷2 g/m2,(1～3 d),静脉滴注,阿糖胞苷在氟达拉滨结束后4 h应用。同期对照组10例AML患者采用大剂量阿糖胞苷进行巩固强化治疗,即Ara-C 3 g/m2,q12 h×3 d。结果 FA组28例AML患者CR时间为109～1 735 d,14例患者持续完全缓解(continuous complete remission,CCR)2年以上,(3年)生存率为21.4%,1 300 d(>3年)的生存率为14.3%,与大剂量阿糖胞苷组没有统计学差异。7例患者于CCR后3～47个月复发,复发患者均存在各种不良预后因素,至少处于中高危分级。不良反应主要为骨髓抑制和继发感染,但总体而言骨髓抑制时间较短,非血液毒性较轻,住院时间在3周左右。结论氟达拉滨能提升胞内Ara-CTP浓度,增强抗白血病作用。FA方案多疗程巩固治疗低中危AML,能减少AML复发,提高总体生存率和无病生存率,临床疗效肯定,不良反应较少,值得进一步深入研究。

Objective To explore the efficacy and adverse effects of the combination of Fludarabine and Cytarabine（FA） as the consolidation therapy for patients with acute myeloid leukemia（AML）.Methods Twenty-eight patients with AML under complete remission were consolidated with FA regimen which includes Fludarabine 30mg/m2（1～3d） and Cytarabine（Ara-C） 2g/m2（1～3d）.Ara-C was administered as a continuous sequential infusion 4 hours later when the application of Fludarabine had been over.Another 10 AML patients with matched conditions treated with high dose Ara-C（Ara-C 3g/ m2,every 12 hrs for 3 d） were designated as controls.Results The time of complete remission in 28 patients in FA group was 109-1,735 days.Fourteen patients（50%） in FA group achieved continuous complete remission for more than 2 years.The survival rates of 3 years and 1,300 days were 21.4% and 14.3% respectively.There was no statistically difference between FA group and HDAra-C group in CCR.Seven patients relapsed after 3-47 months of treatment.The main toxicity was myelosuppression.The time of myelosuppression was short and non-hematotoxicity was gentle.The average hospitalization for FA group was about 3 weeks.Conclusion Fludarabine can increase the concentration of Ara-CTP in cells and enhance its effects of anti-leukemia.The FA regimen is effective and safe as consolidation therapy in AML with acceptable toxicity and is not associated with an increased incidence of infections compared to conventional HDAra-C regimen.