Personalized dosing of cyclophosphamide in the total body irradiation-cyclophosphamide conditioning regimen: a phase II trial in patients with hematologic malignancy.
Personalized dosing of cyclophosphamide in the total body irradiation-cyclophosphamide conditioning regimen: a phase II trial in patients with hematologic malignancy.
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DOI：
10.1038/clpt.2009.27
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发表时间：
2009-06
影响因子：
6.7
通讯作者：
中科院分区：
文献类型：
--
作者：
本研究调查了 50 名接受 CY 联合全身照射 (TBI) 的患者个性化环磷酰胺 (CY) 剂量的有效性和安全性。参与者接受 CY 45 mg/kg，随后使用贝叶斯参数估计进行治疗药物监测，以将第二次 CY 剂量个性化至羧乙基磷酰胺芥末（CY 衍生毒素的报告基因）和羟基环磷酰胺（以确保植入）曲线下的目标区域。第二次 CY 平均剂量为 66 mg/kg；总剂量范围为 45–145 mg/kg。完成这项 II 期研究后，我们将参与者的临床结果与接受标准 CY 剂量 120 mg/kg 的 TBI 的同期对照 (N=100) 的临床结果进行了比较。接受个性化 CY 给药的患者治疗后血清总胆红素峰值显着降低 (p=0.03)；急性肾损伤的风险降低 38% (p=0.03)；尽管大多数患者的 CY 剂量较低，但无复发和总生存率相似（分别为 p=0.70 和 0.63）。
This study investigates the efficacy and safety of personalized cyclophosphamide (CY) dosing in 50 patients receiving CY with total body irradiation (TBI). Participants received CY 45 mg/kg with subsequent therapeutic drug monitoring with Bayesian parameter estimation to personalize the second CY dose to a target area under the curve for carboxyethylphosphoramide mustard (a reporter for CY-derived toxins) and for hydroxycyclophosphamide (to ensure engraftment). The mean second CY dose was 66 mg/kg; the total dose ranged from 45–145 mg/kg. After completion of this phase II study, we compared participants’ clinical outcomes to those of concurrent controls (N=100) who received TBI with standard CY doses of 120 mg/kg. Patients receiving personalized CY dosing had significantly lower post-conditioning peak total serum bilirubin (p=0.03); a 38% reduction in the hazard of acute kidney injury (p=0.03); and similar non-relapse and overall survival (p=0.70 and 0.63, respectively) despite lower doses of CY in most patients.
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影响因子：
20.3
作者：
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