Decitabine improves patient outcomes in myelodysplastic syndromes - Resuits of a Phase III randomized study
Decitabine improves patient outcomes in myelodysplastic syndromes - Resuits of a Phase III randomized study
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作者：
Kantarjian, H;Issa, JPJ;Saba, H
背景。导致白血病发生的异常DNA甲基化在骨髓增生异常综合征（MDS）患者中很常见，并且是药物治疗的一个潜在靶点。地西他滨间接消耗甲基胞嘧啶并导致靶基因启动子的低甲基化。
方法。共有170例MDS患者被随机分配接受地西他滨治疗，剂量为15mg/m²，每8小时静脉输注3小时，连续3天（每个疗程剂量为135mg/m²），每6周重复一次，或接受最佳支持治疗。使用国际工作组标准评估疗效，要求满足疗效标准至少8周。
结果。与支持治疗（0%）相比，接受地西他滨治疗的患者总体缓解率（17%）显著更高，其中包括9%的完全缓解（P<...此处原文似乎不完整，缺少相应的P值比较结果描述>）
BACKGROUND. Aberrant DNA methylation, which results in leukemogenesis, is frequent in patients with myelodysplastic syndromes (MDS) and is a potential target for pharmacologic therapy. Decitabine indirectly depletes methylcytosine and causes hypomethylation of target gene promoters.METHODS. A total of 170 patients with MDS were randomized to receive either decitabine at a dose of 15 mg/m(2) given intravenously over 3 hours every 8 hours for 3 days (at a dose of 135 mg/m(2) per Course) and repeated every 6 weeks, or best supportive care. Response was assessed using the International Working Group criteria and required that response criteria be met for at least 8 weeks.RESULTS. Patients who were treated with decitabine achieved a significantly higher overall response rate (17%), including 9% complete responses, compared with supportive care (0%) (P