• H J Schmoll, M S Aapro, S Poli-Bigelli, H-K Kim, K Park, K Jordan, J von Pawel, H Giezek, T Ahmed, and C Y Chan.
• Martin Luther University Halle/Wittenberg, Halle/Saale, Germany. hans-joachim.schmoll@medizin.uni-halle.de
• Ann. Oncol. 2006 Jun 1;17(6):1000-6.

BackgroundWe compared an aprepitant regimen with a control regimen of ondansetron + dexamethasone given for 4 days.Patients And MethodsPatients scheduled to receive cisplatin > or =70 mg/m(2) 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).ResultsComplete 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 < or = 0.001; acute 89% versus 81%, P = 0.004; delayed 79% versus 64%, P < or = 0.001). Rates of no rescue therapy were similar between groups.ConclusionsCompared 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.

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