Objective To evaluate the efficacy and safely of ultra low-dose decitabine (DAC) in the treatment of elderly patients with moderate-high risk myelodysplastic syndrome (MDS).Methods Totally 33 elderly patients (≥60 years old)with moderate-high risk MDS according to IPSS (International Prognostic Scoring System) from 2014 to 2016 were divided into two groups.Patients in observation group (n =24) were given DAC 7 mg/m2 by vein daily over 1 h on day 1 ～ 10.Cycles were scheduled every 28 d,and patients were treated for a minimum of 4 cycles;9 patients (control group) received best supportive treatment (BST).Results The median age of 33 patients was 73 (60 ～91) years old,and the response data was evaluable for 29 patients with MDS and 3 patients with Chronic myelomonocytic leukemia(CMML).There was no significant difference in patients' characteristics between the two groups (P ＞ 0.05).The rate of complete response (CR) in observation group was 13.04％,and the rate of partial remission (PR) was 8.69％.There were 5 cases with mCR in observation group,in which 2 case gained hematologic improvement (HI),while there was only 1 case with HI in control group.The overall response rate (ORR) in observation group was higher than that of control group:52.17％ (12/23) vs.11.11％ (1/9),P ＜ 0.05.The median OS in observation group was longer than that of control group (8.5 months vs.4.3 months,P ＜ 0.05).The most common adverse reaction was grade Ⅰ ～ Ⅱ myelosuppression.The infection rate in observation group was slightly lower than that of control group (56.52％ vs.77.78 ％,P ＞ 0.05).Conclusion Ultra low-dose decitabine has good clinical efficacy in elderly patients with moderate-high risk MDS,and can achieve significant survival benefits with low incidence of adverse reactions.%目的 观察超低剂量地西他滨(Decitabine,DAC)治疗老年中、高危骨髓增生异常综合征(Myelody splastic syndromes,MDS)患者的近期临床疗效及安全性.方法 选择2014-2016年符合纳入标准的IPSS(International Prognostic Scoring System)评分相对高危(中、高危)老年(≥60岁)MDS患者33例.观察组(24例)给予DAC 7 mg/m2,持续泵入1h以上,连用10 d,28 d为1个治疗周期,入组患者至少完成4个周期治疗.9例采用最佳支持治疗患者作为对照组.结果 33例MDS患者中位年龄73岁(60 ～91岁),29例MDS及3例慢性粒单细胞白血病(Chronic myelomonocytic leukemia,CMML)患者缓解状况可评价,两组患者临床特征差异无统计学意义(P＞0.05).观察组完全缓解(Complete response,CR)率为13.04％,部分缓解(Partial remission,PR)率为8.69％,5例获得骨髓完全缓解(mCR)中2例伴血液学改善(Hematologic improvement,HI);对照组仅1例获得HI.观察组总体反应率(Overall response rate,ORR)为52.17％ (12/23),显著高于对照组11.11％ (1/9),差异有统计学意义(P＜0.05).随访12个月,观察组中位总生存期(OS)为8.5个月,较对照组(4.3个月)差异有统计学意义(P＜0.05).观察组患者耐受性较好,主要不良反应为Ⅰ、Ⅱ级骨髓抑制.观察组患者感染率(56.52％)略低于对照组(77.78％),差异无统计学意义(P＞0.05).结论 超低剂量DAC治疗老年中、高危MDS/CMML患者疗效显著,治疗相关不良反应发生率低,可实现显著的生存获益.
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