小剂量地西他滨联合G-HA预激方案治疗高危MDS的临床研究
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陕西省社会发展科技攻关项目(2015SF070)


Clinical observation of low-dose decitabine combined with G-HA regimen in treatment for patients with high-risk myelodysplastic syndrome
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    摘要:

    目的探讨小剂量地西他滨联合G-HA预激方案治疗高危骨髓增生异常综合征(MDS)的临床疗效和安全性。方法应用小剂量地西他滨联合G-HA预激方案治疗24例初诊高危MDS患者,方案采用:地西他滨10mg/d,静脉滴注,第1~5天;G-HA预激方案包括:高三尖杉酯碱(HHT)1mg/d,静脉滴注,第1~14天,阿糖胞苷(Ara-c)10mg,1次/12h,皮下注射,第1~14天,粒细胞集落刺激因子(G-CSF)300μg,皮下注射,化疗前1天开始,持续使用至化疗结束或外周血白细胞计数>20×109/L。观察临床疗效和不良反应,并进行随访。结果 24例中有16例(66.7%)患者获得完全缓解(CR),3例(12.5%)患者获得部分缓解(PR),总有效率79.2%。在诱导治疗期间发生粒细胞缺乏的比例为75.0%(18例),平均持续时间8天;血小板<20×10~9/L的比例为70.8%(17例),平均持续时间7天;非血液系统不良反应轻微,无早期死亡病例,平均随访时间28个月;平均总生存期(OS)为26个月;平均无病生存期(DFS)为13个月。结论小剂量地西他滨联合G-HA预激方案治疗高危MDS缓解率高,不良反应轻,优于单用地西他滨或单用预激方案,可作为临床治疗MDS的首选方案。

    Abstract:

    Objective This study was aimed to investigate the efficacy and safety of low-dose decitabine combined with G-HA regimen in treatment for patients with high-risk myelodysplastic syndrome(MDS).Methods 24 newly diagnosed adult patients with high-risk MDS were enrolled in the low-dose decitabine combined with G-HA regimen,which consisted of decitabine,10 mg,intravenous continuous infusion,days 1-5.GHA regimen consisted of homoharringtonine1mg/day by intravenous continuous infusion,days 1-14,cytarabine 10mg/12 hr by subcutaneous injection,days 1-14,and G-csf 300mg/day by subcutaneous injection,one day prior to chemotherapy and continued until the end of chemotherapy or when the peripheral WBC>20×109/L.The clinical efficiency and side effects were observed.Results 16 patients achieved CR and 3patients achieved PR.The CR and PR rate were 66.7% and 12.5%,respectively.Total effective rate was 79.2%.In the induction therapy,18patients(75.0%)experienced absolute neutrophol count(ANC)less than 0.5×10~9/L with a mean 8days of agranulocytic period,and 17patients(70.8%)experienced platelets less than20×109/L with a mean 7days of recovery over 20×109/L.The nonhematologic toxicities were mild and early death was zero.The median follow up time was 28months;the median overall survival(OS)and disease free survival(DFS)were26and 13 months,respectively.Conclusion The low-dose decitabine combined with G-HA regimen is effective and well tolerated in induction therapy for high-risk MDS,and the results are better than the single regimen of decitabine or G-HA. 更多

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  • 在线发布日期: 2016-12-02
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