FLAG方案治疗复发/难治的急性髓系白血病患者的临床研究

Clinical study of treatment of patients with relapse or refractory acute myeloid leukemia with FLAG regimen

目的研究FLAG方案治疗复发和难治的急性髓系白血病患者的疗效。病例与方法采用FLAG治疗的为复发和难治性的18～60岁的AML患者,急性早幼粒细胞白血病除外。同时选择既往采用非FLAG治疗的患者作为历史对照组。FLAG方案,即:氟达拉滨30mg/m^2,d1～d5,Ara-C 2g,d1～d5,粒细胞集落刺激因子(G-CSF)5μg/ kg d0直到白细胞恢复超过>1.5×10~9/L。结果FLAG治疗组患者21例完全缓解(CR),CR率为53.85%;对照组患者8例完全缓解,CR率为24.24%;FLAG治疗组患者CR率显著高于对照组(P<0.05)。治疗组患者中位随访时间为7个月(0～17个月),中位OS为6个月(0～17个月)。21例CR的患者随访PFS,中位PFS为10个月(4～17个月)。结论FLAG方案是复发、难治的急性髓系白血病患者治疗的较好选择。

Objectives To evaluate the efficacy of FLAG regime in patients with relapsed or refractory acute myeloid leukemia （AML）. Patients and methods Patients with relapsed or refractory AML （except for APL） were enrolled into the study, with an age range of 18 to 60 years. The treatment group were treated with FLAG regime ： fludarabine 30mg/m^2/d （ dl - 5 ）, Ara - C 2g/d （ dl - 5 ）, and granulocyte colony stimulating factor （G - CSF） 5ug/kg from day 0 till neutrophil recovery （WBC 〉 1.5 × 10^9/L）. The patients with no FLAG regime were regarded as control group. Results In treatment group complete remission （CR） was achieved in 21 （53.85%） of 39 cases. While in control group CR was obtained in 8 （24.24%） of 33 cases. Statistic significance were found in CR rate to compare with the control group （P 〈 0. 05）. The median follow - up time of treatment group was 7 months （range 0 - 17 months） , median OS was 6 months （range 0 -17 months） , and median PFS of 21 patients with CR was 10 months （range 4 - 17 months）. Conclusion FLAG regime is a better choice for patients with relapsed or refractory AML.