Department of Hematology, Democritus University of Thrace Medical School, Alexandroupolis, Greece.
Leuk Res. 2013 Aug;37(8):889-93. doi: 10.1016/j.leukres.2013.05.005. Epub 2013 May 29.
Myelodysplastic syndrome (MDS) patients with renal impairment (RI) were not assessed in the approval trials of 5-azacytidine, thus the optimal use of 5-azacytidine in such patients is currently undefined. We retrospectively analyzed 42 IPSS intermediate-2 and high-risk patients with moderate, mild or no RI undergoing 5-azacytidine therapy in a non-trial setting. We demonstrate that patients in all three groups achieved comparable responses and had similar overall and event-free survival. Likewise, both treatment toxicity and dose adjustments were not significantly influenced by renal function status. A transient but reversible decline in glomerular filtration rate was observed in patients either with or without RI, without affecting the therapeutic schedule. Our results provide the first evidence that 5-azacytidine is effective and well-tolerated in patients with mild and moderate RI and, if confirmed by prospective randomized studies, advocate that such patients can be managed in an analogous fashion to patients with normal renal function.
骨髓增生异常综合征（MDS）伴有肾功能损害（RI）的患者并未在 5-氮杂胞苷的批准试验中进行评估，因此，目前尚不清楚此类患者中 5-氮杂胞苷的最佳使用方法。我们回顾性分析了 42 例 IPSS 中-2 级和高危、伴有中度、轻度或无 RI 的患者，在非试验环境下接受 5-氮杂胞苷治疗。我们证明，所有三组患者的反应相当，总生存和无事件生存相似。同样，肾功能状态对治疗毒性和剂量调整均无显著影响。伴有或不伴有 RI 的患者均观察到肾小球滤过率一过性但可逆性下降，但不影响治疗方案。我们的结果首次提供了证据表明，5-氮杂胞苷在轻度和中度 RI 患者中是有效且耐受良好的，如果前瞻性随机研究得到证实，那么主张可以以类似于肾功能正常患者的方式来管理此类患者。
