A phase II study of 5-day intravenous azacitidine in patients with myelodysplastic syndromes
A phase II study of 5-day intravenous azacitidine in patients with myelodysplastic syndromes
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DOI：
10.1002/ajh.21482
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发表时间：
2009-09-01
影响因子：
12.8
通讯作者：
Vij, Ravi
中科院分区：
文献类型：
--
作者：
Martin, Mike G.;Walgren, Richard A.;Vij, Ravi
批准的 7 天皮下阿扎胞苷治疗骨髓增生异常综合征的方案与注射部位反应和瘀伤有关，并且由于需要周末剂量而可能不方便。尽管静脉注射阿扎胞苷的药代动力学数据表明其等效，但尚未公布疗效数据。患有所有骨髓增生异常综合征（MDS）FAB亚型的患者均入组，并接受阿扎胞苷75 mg/m(2)/d，静脉输注20分钟，每28天连续5天。全球甲基化研究在基线和第 3 周期之前进行。25 名患者入组，其中 22 名患者可评估。中位年龄为 69.5 岁； 9 名 (41%) 患者患有较低风险疾病（IPSS 低或 Int-1），13 名 (59%) 患者患有较高风险疾病（IPSS Int-2 或高）。 27% 的患者有反应（5 例 CR，1 例 PR）。中位反应时间为 108 天。中位 PFS 为 339 天（11.3 个月），中位 OS 为 444 天（14.8 个月），中位缓解持续时间 (DOR) 为 450 天（15.0 个月）。全球甲基化研究表明，应答者的去甲基化程度更高。该方案似乎提供了 PR + CR 率和中位 DOR，与 7 天皮下方案报道的有些相似；然而，CS 较短。是。 J.赫马托尔。 84:560-564, 2009。(C) 2009 Wiley-Liss, Inc.
The approved 7-day schedule of subcutaneous azacitidine for myelodysplastic syndrome is associated with injection site reactions and bruising and may be inconvenient because of the need for weekend doses. Although pharmacokinetic data with IV azacitidine suggests equivalence, there are no efficacy data published. Patients with all myelodysplastic syndromes (MDS) FAB subtypes were enrolled and received 75 mg/m(2)/d of azacitidine by 20-min intravenous infusion for 5 days in every 28 days. Global methylation studies were performed at baseline and prior to Cycle 3. Twenty-five patients were enrolled and 22 were evaluable. Median age was 69.5 years; 9 (41%) patients had lower-risk disease (IPSS Low or Int-1) and 13 (59%) had higher-risk disease (IPSS Int-2 or High). Twenty-seven percent of patients responded (5 CRs and 1 PR). The median time to response was 108 days. The median PFS was 339 days (11.3 months), the median OS was 444 days (14.8 months) and the median duration of response (DOR) was 450 days (15.0 months). Global methylation studies suggest a greater degree of demethylation in responders. This regimen appeared to offer a PR + CR rate and median DOR somewhat similar to what has been reported with the 7-day subcutaneous regimen; however, CS was shorter. Am. J. Hematol. 84:560-564, 2009. (C) 2009 Wiley-Liss, Inc.