Abstract
8552 Background: The disposition of epoetin alfa (EPO, PROCRIT®) has not been well characterized in children. Therefore, we evaluated EPO PK in children with malignant solid tumors undergoing myelosuppressive chemotherapy. Methods: Children in this study were treated at a single center, but were enrolled in a multicenter double-blind, placebo controlled study of EPO. Children received IV EPO 600 IU/kg (max dose 40,000 IU) once weekly for 16 weeks. Serial PK studies were conducted after first EPO dose, and after ninth or tenth EPO dose. Plasma samples were obtained prior to EPO injection and at 0.25, 0.5, 1, 3, 6, 8, and 24 hours after EPO. Plasma EPO concentrations were analyzed using an ELISA assay, with a calibration curve ranging from 0.025 to 0.200 IU/mL. A two-compartment model was fit to the data using maximum likelihood estimation (ADAPT II). Results: 13 children were enrolled in the study, of whom 6 (median age 15.2 yrs; range 9.3–18.6 yrs) were randomized to receive EPO. Results from PK studies p...
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