San Luis Medical Center, Buenos Aires, Argentina.
Leuk Lymphoma. 2010 Dec;51(12):2250-7. doi: 10.3109/10428194.2010.524324. Epub 2010 Oct 7.
This multicenter, open-label study evaluated the efficacy and safety of decitabine in patients from Argentina and South Korea with myelodysplastic syndromes or chronic myelomonocytic leukemia. Of 106 patients who received decitabine 20 mg/m(2) intravenously over 1 h once daily for 5 days in 4-week cycles, 99 patients were evaluable after receiving at least two cycles. The overall improvement rate was 35% (19% complete response +4% marrow complete response +4% partial response +8% hematologic improvement). Overall survival at 2 years was 71%. Treatment-related adverse events included febrile neutropenia, thrombocytopenia and bleeding, asthenia, fatigue, and eosinophilia. After complete response (CR), three patients received an allogeneic stem cell transplant. Four patients who relapsed after CR responded to decitabine retreatment. Acute myelogenous leukemia developed during follow-up in 21% of patients. Decitabine in a 5-day outpatient administration schedule was effective and well tolerated in typical clinical practice settings in South America and Asia.
这项多中心、开放性研究评估了地西他滨在来自阿根廷和韩国的骨髓增生异常综合征或慢性粒单核细胞白血病患者中的疗效和安全性。106 名患者接受地西他滨 20mg/m(2)，静脉输注 1 小时，每日 1 次，每 4 周为 1 个周期，至少接受 2 个周期治疗后，99 名患者可评估疗效。总体缓解率为 35%（19%完全缓解+4%骨髓完全缓解+4%部分缓解+8%血液学改善）。2 年总生存率为 71%。治疗相关不良事件包括发热性中性粒细胞减少症、血小板减少症和出血、乏力、疲乏和嗜酸性粒细胞增多症。完全缓解（CR）后，3 名患者接受了异基因造血干细胞移植。4 名 CR 后复发的患者对地西他滨再治疗有反应。21%的患者在随访期间发生急性髓系白血病。地西他滨在南美洲和亚洲的典型临床实践环境中，5 天门诊给药方案有效且耐受良好。
