Levine Lauren B, Roddy Julianna Vf, Kim Miryoung, Li Junan, Phillips Gary, Walker Alison R
1 Department of Pharmacy, The James Cancer Hospital and Solove Research Institute at The Ohio State University, Columbus, OH, USA.
2 College of Pharmacy, The Ohio State University, Columbus, OH, USA.
J Oncol Pharm Pract. 2018 Jun;24(4):290-298. doi: 10.1177/1078155217702213. Epub 2017 Mar 26.
Purpose There are limited data regarding the clinical use of decitabine for the treatment of acute myeloid leukemia in patients with a serum creatinine of 2 mg/dL or greater. Methods We retrospectively evaluated 111 patients with acute myeloid leukemia who had been treated with decitabine and compared the development of toxicities during cycle 1 in those with normal renal function (creatinine clearance greater than or equal to 60 mL/min) to those with renal dysfunction (creatinine clearance less than 60 mL/min). Results Notable differences in the incidence of grade ≥3 cardiotoxicity (33% of renal dysfunction patients vs. 16% of normal renal function patients, p = 0.042) and respiratory toxicity (40% of renal dysfunction patients vs. 14% of normal renal function patients, p = 0.0037) were observed. The majority of heart failure, myocardial infarction, and atrial fibrillation cases occurred in the renal dysfunction group. The odds of developing grade ≥3 cardiotoxicity did not differ significantly between patients with and without baseline cardiac comorbidities (OR 1.43, p = 0.43). Conclusions This study noted a higher incidence of grade ≥3 cardiac and respiratory toxicities in decitabine-treated acute myeloid leukemia patients with renal dysfunction compared to normal renal function. This may prompt closer monitoring, regardless of baseline cardiac comorbidities. Further evaluation of decitabine in patients with renal dysfunction is needed.
关于地西他滨用于治疗血清肌酐水平为2mg/dL或更高的急性髓系白血病患者的临床应用数据有限。方法：我们回顾性评估了111例接受地西他滨治疗的急性髓系白血病患者，并比较了肾功能正常（肌酐清除率大于或等于60mL/min）与肾功能不全（肌酐清除率小于60mL/min）患者在第1周期的毒性反应发生情况。结果：观察到≥3级心脏毒性（肾功能不全患者为33%，肾功能正常患者为16%，p = 0.042）和呼吸毒性（肾功能不全患者为40%，肾功能正常患者为14%，p = 0.0037）的发生率存在显著差异。大多数心力衰竭、心肌梗死和心房颤动病例发生在肾功能不全组。有或无基线心脏合并症的患者发生≥3级心脏毒性的几率无显著差异（比值比1.43，p = 0.43）。结论：本研究指出，与肾功能正常的患者相比，肾功能不全的地西他滨治疗急性髓系白血病患者发生≥3级心脏和呼吸毒性的发生率更高。无论基线心脏合并症如何，这可能促使进行更密切的监测。需要对肾功能不全患者中的地西他滨进行进一步评估。
