Xie Mixue, Jiang Qi, Li Li, Zhu Jingjing, Zhu Lixia, Zhou De, Zheng Yanlong, Yang Xiudi, Zhu Mingyu, Sun Jianai, Xie Wanzhuo, Ye Xiujin
Senior Department of Haematology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, 310003, China.
Department of Medical Oncology, The First Affiliated Hospital, College of Medicine, Zhejiang University, Hangzhou, Zhejiang Province, 310003, China.
PLoS One. 2016 Oct 5;11(10):e0164238. doi: 10.1371/journal.pone.0164238. eCollection 2016.
In China, the combination of homoharringtonine, cytarabine, and G-CSF (HAG) has been extensively applied for treatment of acute myeloid leukemia (AML) and myelodysplastic syndrome (MDS).
We performed a meta-analysis of 2,314 patients (AML, n = 1754; MDS, n = 560) to determine the overall safety and efficacy of this regimen.
The complete response (CR) rate of AML patients (53%) was significantly higher than that of MDS/transformed-AML patients (45%; P = 0.007). The CR rate of patients with newly diagnosed AML (62%) was significantly higher than in patients with relapsed/refractory AML (50%; P = 0.001). There were no significant difference in CR rates between elderly AML patients (54%) and all AML patients (P = 0.721). When compared with non-HAG regimens for AML/MDS induction therapy, the CR rate of patients treated with HAG was significantly higher than in treated with intensive chemotherapy (P = 0.000). No significant differences in CR rates were observed between patients treated with HAG and those treated with CAG (cytarabine, aclarubicin, G-CSF) regimens (P = 0.073). HAG regimen was well tolerated, with early death (ED) in 2%, grade IV myelosurrpression in 52% and infection in 50%. Reports of ED and rates of myelosuppression were reduced as compared with intensive chemotherapy (P = 0.000 and P = 0.000, respectively).
The HAG regimen is an effective and safe regimen for the treatment of AML and MDS, and appears to be more effective and better tolerated than intensive chemotherapy. Future randomized controlled trials and further meta-analyses are strongly needed to confirm its efficacy and safety, especially in comparison with intensive chemotherapy.
在中国,高三尖杉酯碱、阿糖胞苷和粒细胞集落刺激因子(HAG)联合方案已广泛应用于急性髓系白血病(AML)和骨髓增生异常综合征(MDS)的治疗。
我们对2314例患者(AML患者1754例,MDS患者560例)进行了荟萃分析,以确定该方案的总体安全性和疗效。
AML患者的完全缓解(CR)率(53%)显著高于MDS/转化型AML患者(45%;P = 0.007)。初诊AML患者的CR率(62%)显著高于复发/难治性AML患者(50%;P = 0.001)。老年AML患者的CR率(54%)与所有AML患者相比无显著差异(P = 0.721)。与用于AML/MDS诱导治疗的非HAG方案相比,接受HAG治疗的患者CR率显著高于接受强化化疗的患者(P = 0.000)。接受HAG治疗的患者与接受CAG(阿糖胞苷、阿克拉霉素、粒细胞集落刺激因子)方案治疗的患者CR率无显著差异(P = 0.073)。HAG方案耐受性良好,早期死亡率为2%,IV度骨髓抑制率为52%,感染率为50%。与强化化疗相比,早期死亡报告和骨髓抑制率均有所降低(分别为P = 0.000和P = 0.000)。
HAG方案是治疗AML和MDS的有效且安全的方案,似乎比强化化疗更有效且耐受性更好。强烈需要未来进行随机对照试验和进一步的荟萃分析来证实其疗效和安全性,特别是与强化化疗相比。