Multicenter, Phase II Study of Decitabine for the First-Line Treatment of Older Patients With Acute Myeloid Leukemia
Multicenter, Phase II Study of Decitabine for the First-Line Treatment of Older Patients With Acute Myeloid Leukemia
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DOI：
10.1200/jco.2009.23.9178
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发表时间：
2010-02-01
影响因子：
45.3
通讯作者：
DiPersio, John F.
中科院分区：
文献类型：
--
作者：
Cashen, Amanda F.;Schiller, Gary J.;DiPersio, John F.
目的老年急性髓细胞白血病（AML）患者的治疗选择有限，因为现有的治疗方法缺乏有效性和毒性。我们调查了低甲基化剂地西他滨作为初治老年患者AML.Patients和MethodsIn这个多中心，II期研究的疗效和毒性，患者年龄超过60岁谁有AML（即，> 20%的骨髓原始细胞），并没有预先治疗AML与地西他滨20毫克/平方米（2）静脉内连续5天的4周周期。在第2周期和随后的每个周期后，通过每周CBC和骨髓活检评估缓解。患者继续接受地西他滨，直到疾病进展或不可接受的不良事件occupational. ResultsFifty患者（平均年龄，74岁）被招募，并与地西他滨的中位数为3个周期（范围，1至25个周期）的治疗。专家评审的总体缓解率为25%（完全缓解率为24%）。各亚组的缓解率一致，包括低风险细胞遗传学患者和有骨髓增生异常综合征病史的患者。总体中位生存期为7.7个月，30天死亡率为7%。最常见的毒性是骨髓抑制，发热性中性粒细胞减少症，和fatigue.ConclusionDecitabine给予低剂量，5天的方案具有活性的前期治疗老年AML患者，它有可接受的毒性和30天的死亡率。
PurposeOlder patients with acute myeloid leukemia (AML) have limited treatment options because of the lack of effectiveness and the toxicity of available therapies. We investigated the efficacy and toxicity of the hypomethylating agent decitabine as initial therapy in older patients with AML.Patients and MethodsIn this multicenter, phase II study, patients older than 60 years who had AML (ie, > 20% bone marrow blasts) and no prior therapy for AML were treated with decitabine 20 mg/m(2) intravenously for 5 consecutive days of a 4-week cycle. Response was assessed by weekly CBC and bone marrow biopsy after cycle 2 and after each subsequent cycle. Patients continued to receive decitabine until disease progression or an unacceptable adverse event occurred.ResultsFifty-five patients (mean age, 74 years) were enrolled and were treated with a median of three cycles (range, one to 25 cycles) of decitabine. The expert-reviewed overall response rate was 25% (complete response rate, 24%). The response rate was consistent across subgroups, including in patients with poor-risk cytogenetics and in those with a history of myelodysplastic syndrome. The overall median survival was 7.7 months, and the 30-day mortality rate was 7%. The most common toxicities were myelosuppression, febrile neutropenia, and fatigue.ConclusionDecitabine given in a low-dose, 5-day regimen has activity as upfront therapy in older patients with AML, and it has acceptable toxicity and 30-day mortality.