Efficacy and safety of aprepitant combined with ondansetron and dexamethasone in the prevention of chemotherapy-induced nausea and vomiting

Objective To evaluate the efficacy and safety of the new combination (aprepitant/ondansetron/dexamethasone) in the prevention of chemotherapy-induced nausea and vomiting (CINV). Methods This was a prospective non-randomized, self-control single site study, and 43 patients receiving high and moderate emetic risk chemotherapy were enrolled. All patients received the following regimen for the prevention of CINV (day 1, 125 mg aprepitant, 16 mg ondansetron, and 10 mg dexamethasone before chemotherapy; and days 2-3, 80 mg aprepitant, 16 mg ondansetron, and 10 mg dexamethasone each day). The same dose of ondansetron and dexamethasone was used as self-control in the previous or next course of the chemotherapy in the same patient. The primary end point was the proportion of patients with complete response (no emesis and no rescue therapy) during the 120 h post-chemotherapy. Toxicity assessments were conducted using the NCI-CTC investigator guide (version 4.0). Results The overall complete response (CR) rates were 72.1% in the aprepitant group (31/43) versus 51.2% in the self-control group (22/43; χ2=3.98, P 0.05). For the delayed phase, the CR rates were 76.7% (33/43) and 55.8% (24/43), respectively (χ2=4.21, P<0.05). Toxicity and adverse events were comparable in both groups. Conclusion The combination of aprepitant, ondansetron and dexamethasone is effective and well tolerable for CINV prevention in cancer patients receiving high and moderate emetic risk chemotherapy. Key words: Nausea; Vomiting; Antineoplastic combined chemotherapy protocols; Treatment outcome; Aprepitant