Department of Clinical Pharmacy, College of Pharmacy, University of Michigan, Ann Arbor, Michigan.
Department of Surgery, Michigan Medicine, University of Michigan, Ann Arbor, Michigan.
Pharmacotherapy. 2020 Apr;40(4):308-319. doi: 10.1002/phar.2379. Epub 2020 Mar 27.
High-dose methotrexate (HD-MTX) is used to treat primary central nervous system lymphoma (PCNSL), but potential differences in MTX clearance (CL) due to obesity have not been studied. We characterized the relationship between HD-MTX CL and computed tomography (CT)-generated body composition (morphomic), body size descriptors, and laboratory measurements in a cohort of obese and non-obese patients with PCNSL.
Medical records from adult patients with PCNSL treated with HD-MTX over a 10-year period were queried. Individuals with CT data within 30 days of the first cycle of treatment were included. Population pharmacokinetic analysis was performed using a 2-compartment base structural model. We specifically compared body surface area (BSA) to standard body size, morphomic, and renal function estimation methods as covariates of HD-MTX CL.
The final data set consisted of non-obese (n=45) and obese (n=28) patients with 291 observations (3-7 samples per patient) with a mean (standard deviation) weight of 69.8 (11.6) kg and 104 (14.9) kg, respectively (p=0.0001). Vertebral body height was more informative than BSA of MTX CL. Similarly, a CL model incorporating age, albumin, and serum creatinine was more informative than kidney function equations and body size. The final model of MTX CL was based on age, albumin, serum creatinine, and vertebral body height.
Common clinical variables coupled with vertebral body height are more predictive of first cycle MTX CL than BSA, alternate body size descriptors, and commonly used kidney function equations.
大剂量甲氨蝶呤(HD-MTX)用于治疗原发性中枢神经系统淋巴瘤(PCNSL),但尚未研究肥胖患者因 MTX 清除率(CL)不同而产生的差异。我们在一组肥胖和非肥胖的 PCNSL 患者中,通过 CT 生成的身体成分(形态学)、身体大小描述符和实验室测量来描述 HD-MTX CL 与之间的关系。
查询了在过去 10 年内接受 HD-MTX 治疗的 PCNSL 成年患者的病历。包括在第一个治疗周期的 30 天内有 CT 数据的患者。采用双室基础结构模型进行群体药代动力学分析。我们特别比较了体表面积(BSA)与标准身体大小、形态学和肾功能估计方法作为 HD-MTX CL 的协变量。
最终数据集包括非肥胖(n=45)和肥胖(n=28)患者,共 291 个观察值(每个患者 3-7 个样本),平均(标准差)体重分别为 69.8(11.6)kg 和 104(14.9)kg(p=0.0001)。椎体高度比 BSA 更能反映 MTX CL。同样,纳入年龄、白蛋白和血清肌酐的 CL 模型比肾功能方程和身体大小更具信息量。MTX CL 的最终模型基于年龄、白蛋白、血清肌酐和椎体高度。
与 BSA 相比,常见的临床变量加上椎体高度比 BSA、替代身体大小描述符和常用的肾功能方程更能预测第一个周期的 MTX CL。