FA方案巩固强化治疗急性髓系白血病的临床观察

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。

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

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.