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首页> 美国卫生研究院文献>BMC Blood Disorders >More is less, less is more, or does it really matter? The curious case of impact of azacitidine administration schedules on outcomes in patients with myelodysplastic syndromes
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More is less, less is more, or does it really matter? The curious case of impact of azacitidine administration schedules on outcomes in patients with myelodysplastic syndromes

机译：少即是多，少即是多，还是真的重要？阿扎胞苷给药方案对骨髓增生异常综合症患者结局影响的奇怪案例

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Myelodysplastic syndromes (MDS) encompass a diverse group of hematologic disorders characterized by ineffective and malignant hematopoiesis, peripheral cytopenias and significantly increased risk of progression to acute myeloid leukemia (AML). The hypomethylating agents (HMA) azacitidine and decitabine induce meaningful clinical responses in a significant subset of patients with MDS. Though never compared directly with decitabine, only azacitidine has improved overall survival (OS) compared to conventional care in a randomized trial in patients with higher-risk MDS. The azacitidine regimen used in this pivotal trial AZA-001 included administration at 75 mg/m2/day for 7 consecutive days in 28-day cycles (7–0 regimen). Given the logistical difficulties of weekend administration in the 7–0 regimen, as well as in efforts to improve response rates, alternative dosing schedules have been used. In a typical 28-day cycle, administration schedules of 3, 5, 10, and (with the oral version of azacitidine) 14 and 21 days have been used in clinical trials. Most trials that evaluated alternative administration schedules of azacitidine did so in lower-risk MDS and did not directly compare to the 7–0 schedule. Given the lack of randomized prospective studies comparing the 7–0 schedule to the other regimens of azacitidine in MDS, Shapiro et al. conducted a systematic review in an attempt to answer this question. Here we place the findings of this important work in clinical context and review the current knowledge and unresolved issues regarding the impact of administration schedules of azacitidine on outcomes of patients with both lower-risk and higher-risk MDS.
机译：骨髓增生异常综合症（MDS）涵盖了多种血液系统疾病，其特征在于无效和恶性的造血功能，外周血细胞减少和发展为急性髓细胞性白血病（AML）的风险显着增加。次甲基化剂（HMA）阿扎胞苷和地西他滨在MDS患者的重要子集中诱导有意义的临床反应。尽管从未将其与地西他滨直接进行比较，但在具有较高风险的MDS患者的随机试验中，与传统护理相比，仅阿扎胞苷具有更好的总体生存率。在这项关键性试验AZA-001中使用的阿扎胞苷方案包括在28天的周期中连续7天以75 mg / m 2 /天的剂量给药（7-0方案）。鉴于在7-0方案中周末管理的后勤困难，以及在努力提高反应率方面，已使用了替代给药方案。在典型的28天周期中，在临床试验中使用了3、5、10和14天和21天（含阿扎胞苷口服）的给药方案。大多数评估阿扎胞苷替代治疗方案的试验都是在较低风险的MDS中进行的，并未直接与7-0方案进行比较。由于缺乏将7-0方案与MDS中的其他阿扎胞苷方案进行比较的随机前瞻性研究，Shapiro等人。为了回答这个问题进行了系统的审查。在这里，我们将这项重要工作的发现置于临床环境中，并回顾了有关阿扎胞苷给药方案对低危和高危MDS患者预后的影响的当前知识和未解决的问题。

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