1338PD - Emesis rate and rescue medication use in children using aprepitant to prevent chemotherapy-induced nausea and vomiting (CINV)

Date 29 September 2014
Event ESMO 2014
Session Supportive and palliative care
Topics Complications of Treatment
Supportive Care
Cancer in Special Situations
Presenter Hyoung Jin Kang
Citation Annals of Oncology (2014) 25 (suppl_4): iv471-iv477. 10.1093/annonc/mdu350
Authors H.J. Kang1, S. Loftus2, A. Taylor3, C. Dicristina4, S. Green5, C. Zwaan6
  • 1Pediatrics, Seoul National University College of Medicine, Seoul National University Hospital, 110-799 - Seoul/KR
  • 2Respiratory And Immunology, Merck & Co., Inc., North Wales/US
  • 3Biostatistics And Research Decision Sciences, Merck & Co., Inc., Upper Gwynedd/US
  • 4Clinical Development Execution Organization, Merck & Co., Inc., North Wales/US
  • 5Clinical Research, Merck Research Laboratories, Kenilworth/US
  • 6Pediatric Oncology, Erasmus MC, Rotterdam/NL

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 <12 y old received aprepitant powder-for-suspension (PFS) 3 mg/kg (up to 125 mg) + ondansetron (Day 1) + aprepitant PFS 2 mg/kg (up to 80 mg) (Days 2-3), OR placebo (Days 1-3) + ondansetron (Day 1). The primary objective was to compare the aprepitant and control regimens in eliciting a complete response 25-120 hours (h) after chemo initiation. Exploratory endpoints included the proportion of patients with no emetic episodes (acute, 0-24 h; delayed, 25-120 h after chemo initiation), time to first vomiting, proportion of patients not requiring rescue medication, and time to first use of rescue medication during the overall phase (0-120 h).

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 < 0.0001). The proportion of patients not requiring rescue medication use was higher for aprepitant vs control (66.4% vs 48.7%), and the time to first rescue medication use was longer for aprepitant vs control (P = 0.0024). Adverse events were similar between regimens and consistent with those in patients undergoing chemo.

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.