Fludarabine and cytarabine versus high-dose cytarabine in consolidation treatment of t(8;21) acute myeloid leukemia: A prospective, randomized study
Fludarabine and cytarabine versus high-dose cytarabine in consolidation treatment of t(8;21) acute myeloid leukemia: A prospective, randomized study
复制标题
氟达拉滨和阿糖胞苷与大剂量阿糖胞苷在 t(8;21) 急性髓系白血病巩固治疗中的比较：一项前瞻性、随机研究
DOI：
10.1002/ajh.24569
复制
发表时间：
2017
影响因子：
12.8
通讯作者：
Song Xianmin
中科院分区：
文献类型：
--
作者：
Li Ruiqi;Hu Xiaoxia;Wang Libing;Cheng Hui;Lv Shuqing;Zhang Weiping;Wang Jianmin;Yang Jianmin;Song Xianmin
伴有t（8;21）畸变的急性髓性白血病（AML）患者通常具有良好的结局，然而，30-40%的患者仍会复发，只有50-60%的t（8;21）AML患者通过含有高剂量阿糖胞苷（HD‐Ara‐C）的方案治愈。为了评价氟达拉滨和阿糖胞苷（FA）巩固治疗（8;21）AML患者的疗效，进行了一项前瞻性随机研究。共45例达到完全缓解（CR）后的t（8;21）AML患者被随机分配接受FA（n= 23）或HD‐Ara‐C（n= 22）的4个疗程巩固治疗。我们的研究显示，FA组和HD‐Ara‐C组在36个月时的无复发生存率（RFS）分别为81.73%和50.73%（P= 0.04），总生存率分别为91.1%和48.4% FA组和HD‐Ara‐C组分别为（P= 0.01）;而FA组和HD‐Ara‐C组的累积复发率（CIR）分别为18.27%和47.39%（P= 0.05）。在我们的研究中，FA治疗，MRD 2状态（减少≥ 3-log）和无c-kit突变被确定为复发风险较低、RFS和OS改善的独立预后因素。我们还发现，FA组无c-kit突变患者的RFS为100%，HD-Ara-C组为57.8%。（P= 0.005）; 36个月时两组的OS分别为100%和51.4%（P= 0.004），表明FA巩固治疗对t（8;21）AML患者，尤其是无c-kit突变的患者有获益（Clinicaltrials.org ID NCT# 02024308）。Am. J. Hematol. 92：12-17，2017.© 2016 Wiley Periodicals，Inc.
Acute myeloid leukemia (AML) patients witht(8;21) aberration often have favorable outcomes, however, relapse still occurs in 30–40% patients, with only 50–60% of patients witht(8;21) AML cured with regimens containing high‐dose cytarabine (HD‐Ara‐C). To evaluate the effects of fludarabine and cytarabine (FA) consolidation therapy fort(8;21) AML patients, a prospective randomized study was performed. A total of 45 patients witht(8;21) AML after achieving complete remission (CR) were randomly assigned to receive four course consolidation with FA (n= 23) or HD‐Ara‐C (n= 22). Our study showed that at 36‐months, relapse‐free survival (RFS) was 81.73% in the FA arm and 50.73% in the HD‐Ara‐C arm (P= 0.04), overall survival (OS) was 91.1% and 48.4% (P= 0.01) in the FA arm and in the HD‐Ara‐C arm respectively; whereas cumulative incidence of relapse (CIR) was 18.27% and 47.39%, in the FA arm and in the HD‐Ara‐C arm respectively (P= 0.05). In our study, treatment with FA, MRD2 status (reduction ≥ 3‐log) and absence of c‐kit mutations were identified as independent prognostic factors for lower risk of relapse, improved RFS and OS. We also found RFS for patients without c‐kit mutations was 100% in FA arm, and 57.8% in HD‐Ara‐C arm at 36 months (P= 0.005); OS of both groups at 36 months was 100% and 51.4%, respectively (P= 0.004), suggesting a benefit of consolidation therapy with FA for t(8;21) AML patients, especially, those without c‐kit mutations (Clinicaltrials.org ID NCT# 02024308). Am. J. Hematol. 92:12–17, 2017. © 2016 Wiley Periodicals, Inc.