Emesis Rate and Rescue Medication Use in Children Using Aprepitant to Prevent Chemotherapy-Induced Nausea and Vomiting (Cinv)

Abstract

ABSTRACT Aim: Aprepitant, in combination with a 5HT3-antagonist and a corticosteroid, is indicated for prevention of CINV due to highly/moderately emetogenic chemotherapy (chemo) in adults. To evaluate aprepitant for CINV prevention in children, a phase III, randomized, double-blind, active-comparator study was conducted in pediatric patients (NCT01362530). Methods: Patients ages 12-17 years (y) undergoing highly/moderately emetogenic chemo received aprepitant capsule 125 mg + ondansetron before chemo (Day 1) + aprepitant capsule 80 mg (Days 2-3), OR placebo (Days 1-3) + ondansetron (Day 1). Patients 6 months to Results: Efficacy and safety were evaluated in 152 aprepitant and 150 control patients. The proportion of patients experiencing no emetic episodes was higher in the aprepitant regimen vs the control regimen during both acute (71.1% vs 53.3%) and delayed (55.3% vs 28.0%) phases. The median time to first vomiting (overall) was significantly longer for aprepitant vs control (94.5 vs 26.0 hours; P Conclusions: In pediatric patients with cancer receiving emetogenic chemo, the 3-day aprepitant regimen prevented emetic episodes and reduced the need for rescue medication compared with a 5HT3-antagonist regimen without aprepitant. Disclosure: H.J. Kang: Received research funding from Merck & Co., Inc. MK869 PN208 study involvement; S. Loftus: Full-time employee of Merck & Co., Inc., with stock ownership; A. Taylor: Full-time employee of Merck & Co., Inc.; C. Dicristina: Full-time employee of Merck & Co., Inc.; S. Green: Full-time employee of Merck & Co., Inc., with stock ownership. All other authors have declared no conflicts of interest.