Comparison of an aprepitant regimen with a multiple-day ondansetron regimen, both with dexamethasone, for antiemetic efficacy in high-dose cisplatin treatment

Abstract

Background: We compared an aprepitant regimen with a control regimen of ondansetron + dexamethasone given for 4 days. Patients and methods: Patients scheduled to receive cisplatin ≥70 mg/m² were randomized to either the aprepitant regimen (aprepitant, ondansetron and dexamethasone on day 1; aprepitant and dexamethasone on days 2–3; dexamethasone on day 4) or control regimen (ondansetron + dexamethasone on days 1–4). Patients recorded vomiting, nausea and rescue therapy use. The primary end point was complete response (no vomiting and no use of rescue therapy) in the overall phase (days 1–5 post-cisplatin). Results: Complete response rates were higher in the aprepitant than control group in the overall (72% versus 61%; P = 0.003), acute (day 1; 88% versus 79%; P = 0.005) and delayed phases (days 2–5; 74% versus 63%; P = 0.004), as were rates of no vomiting (overall 77% versus 62%, P ≤ 0.001; acute 89% versus 81%, P = 0.004; delayed 79% versus 64%, P ≤ 0.001). Rates of no rescue therapy were similar between groups. Conclusions: Compared with an antiemetic regimen in which ondansetron + dexamethasone were given for 4 days, the aprepitant regimen was superior in the acute, delayed and overall phases of chemotherapy-induced nausea and vomiting. The aprepitant regimen should be considered a new standard of antiemetic therapy for cisplatin-treated patients. www.ClinicalTrials.gov Identifier: NTC00090207