Weinstein, C., Jordan, K., Green, S.A., Camacho, E., Khanani, S., Beckford-Brathwaite, E., . . . Rapoport, B. L. (2016). Single-dose fosaprepitant for the prevention of chemotherapy-induced nausea and vomiting associated with moderately emetogenic chemotherapy: Results of a randomized, double-blind phase III trial. Annals of Oncology, 27, 172–178.
To assess the efficacy and safety of a single dose of fosaprepitant (150 mg IV) combined with a 5-HT3 receptor antagonist and a corticosteroid versus a standard 5-HT3 receptor antagonist and a corticosteroid for the prevention of chemotherapy-induced nausea and vomiting (CINV)
Patients received fosaprepitant versus placebo with ondansetron plus dexamethasone on day 1. Oral ondansetron and dexamethasone were used. Patients who received fosaprepitant on day 1 received placebo medication on days 2–3, while those in the control group received ondansetron every 12 hours. Rescue medications were allowed at the discretion of the provider.
Complete response (CR) in delayed phase met superiority for the experimental fosaprepitant group versus the control group (p < 0.001) and for the overall phase (p < 0.001). Both regimens had high CR in the acute phase with no significant differences (p = 0.184). Fosaprepitant was superior to the control group for no vomiting in the overall phase (p < 0.001) and delayed phase (p < 0.001), and the time to first vomiting (p < 0.001). Fosaprepitant group had significantly more “no significant nausea” patients than the control group (p = 0.026).
Fosaprepitant demonstrated superior CR overall to oral ondansetron and dexamethasone alone in MEC regimens. These results are similar to results seen in highly emetogenic chemotherapy. Treatment differences of 0.1% in delayed and overall phases are seen to be clinically meaningful for patients.
Fosaprepitant may be safely used in patients receiving MEC. Further study is warranted.