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 25; 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. © 2006 Oxford University Press.