Rapoport, B.L., Jordan, K., Boice, J.A., Taylor, A., Brown, C., Hardwick, J.S., … Schmoll, H.J. (2010). Aprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with a broad range of moderately emetogenic chemotherapies and tumor types: A randomized, double-blind study. Supportive Care in Cancer, 18, 423–431.
To determine the efficacy, safety, and tolerability of aprepitant for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving moderately emetogenic chemotherapy (MEC) regimens and to determine if aprepitant would provide a complete response at preventing CINV in the first 5 days (120 hours) following chemotherapy
Patients naïve to moderately or highly emetogenic chemotherapy (HEC) and scheduled to receive a single dose of MEC agent, were enrolled in the study. Group one received an aprepitant triple-therapy regimen; group two received a control regimen that included a placebo 1 hour prior to chemotherapy, ondansetron (same dosing as aprepitant group), and dexamethasone on day 1, and, on days 2 and 3, placebo once daily and ondansetron twice daily (by mouth).
Studies were conducted at multiple sites in the United States, Mexico, Canada, Chile, Brazil, Peru, Colombia, Panama, Hong Kong, Australia, South Africa, France, Germany, Israel, and Russia.
Patients were in active treatment.
The study was a phase III, prospective, randomized, gender-stratified, double-blind trial.
Patients recorded the time and date of nausea, retching, and vomiting episodes in diaries. Nausea was assessed daily using a 100-mm horizontal visual analogue scale (VAS). If a rescue drug was used, the drug name and date and time of administration was recorded. Common Terminology of Adverse Events, version 3.0 (CTAE v 3.0) was used to assign toxicity grades to all laboratory test results and adverse events.
The aprepitant regimen provided significantly more vomiting-free time. Better control with an aprepitant–containing, triple antiemetic regimen was seen for those receiving MEC (nonanthracycline and cyclophosphamide [AC] or AC).
Aprepitant was effective in preventing chemotherapy-associated vomiting in patients receiving a broad range of MEC and should be considered as part of a standard antiemetic regimen.