The effect of a 3-day oral aprepitant regimen on the prevention of CINV over standard therapy in Chinese patients receiving high-dose cisplatin.

9105 Background: Clinical studies have shown that Aprepitant (APR), a Neurokinin-1 receptor antagonist, is efficacious in preventing chemotherapy induced nausea and vomiting (CINV) and well tolerated. The efficacy, safety, and tolerability of APR in Chinese patients have not been studied. In this phase III, multicenter, double-blind, placebo-controlled, randomized study, we assessed the efficacy, safety, and tolerability of a 3-day oral APR regimen compared with that provided by a standard therapy regimen (ST) in Chinese patients. Methods: Four hundred twenty-one patients receiving chemotherapy including cisplatin (≥70 mg/m2) were randomly assigned (1:1) to receive the APR regimen (APR 125 mg po d1 and 80 mg d2-3, granisetron 3 mg iv d1, DEX 6 mg po d1, and 3.75 mg d2-4) (n=209) or the ST (placebo d1-3, granisetron 3 mg iv d1, and DEX 10.5 mg d1 and 7.5 mg d2-4) (n=212). The primary endpoint was the percentage of patients with complete response (CR; no emesis and no use of rescue therapy) in the overall p...