Fosaprepitant for CINV Prevention Dose Proportional in Older Pediatric Patients
Fosaprepitant is used to prevent CINV in adult patients, and this phase 2b dose-ranging study of pediatric patients aged newborn to 17 years determined the appropriate doses for younger patients.
Fosaprepitant was dose proportional when used among pediatric patients with cancer for the prevention of chemotherapy-induced nausea/vomiting (CINV), but patients younger than 12 years may require higher doses, according to study results presented at the 2017 Palliative and Supportive Care in Oncology Symposium.
Adult patients with cancer are treated with fosaprepitant to prevent CINV, but the appropriate dosing in pediatric patients is unknown. The purpose of this study was to evaluate the pharmacokinetic and pharmacodynamic profile, safety, and efficacy of fosaprepitant in this patient population.
For this dose-ranging phase 2b study, researchers randomly assigned 234 pediatric patients with cancer to receive fosaprepitant concurrently with ondansetron, with or without dexamethasone. Eligible patients were to receive emetogenic chemotherapy, and ranged in age from newborn to 17 years.
Of the 167 patients with evaluable pharmacokinetic data, fosaprepitant doses were found to be dose proportional. Exposure in patients aged 12 to 17 years who received fosaprepitant 150 mg was similar to adults who were administered the same dose.
Pediatric patients who were younger than 12 years had higher clearance rates and required a higher weight-normalized dose of 5 mg/kg to reach comparable exposure.
The most frequently reported adverse event (AE) was hiccups, and the safety profile was consistent with the typical AE profiles of patients with cancer receiving emetogenic chemotherapy. Only one patient was unable to complete cycle 1 of treatment, and another discontinued treatment due to anaphylactic reaction.
1. Mora J, Valero M, DiCristina C, et al. Pharmacokinetics/pharmacodynamics (PK/PD), safety, and tolerability of fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) in pediatric subjects. Poster presentation at: 2017 Palliative and Supportive Care in Oncology Symposium; October 27-28, 2017; San Diego, CA. Abstract 93.