In the study, 71.9 percent of patients who received an antiemetic regimen that included a single, 150 mg dose of fosaprepitant , ondansetron 32 mg IV, and dexamethasone 12 mg orally on Day 1, and dexamethasone 8 mg orally on Day 2, and dexamethasone 8 mg orally twice daily on Days 3 and 4 achieved a complete response, defined as no vomiting and no use of rescue medication, in the overall phase of chemotherapy (0 to 120 hours post-initiation of cisplatin-based chemotherapy) compared to 72.3 percent of those receiving an antiemetic regimen containing a three-day oral regimen of EMEND (EMEND 125 mg orally, ondansetron 32 mg IV, and dexamethasone 12 mg orally on Day 1, EMEND 80 mg orally once daily on Days 2 and 3, and dexamethasone 8 mg orally once daily on Days 2 through 4; 95 percent confidence interval [CI] for difference between groups = -4.1 to 3.3). In addition, 74.3 percent of patients treated with the regimen containing the single, 150 mg dose of fosaprepitant achieved a complete response in the delayed phase (25 to 120 hours post cisplatin-based chemotherapy), compared to 74.2 percent of patients treated with a regimen containing a three-day regimen of EMEND. (95 percent CI for difference between groups = -3.5 to 3.7).

The overall incidence and types of adverse events were generally consistent between the two treatment groups. The most frequently reported drug-related clinical adverse events in both the group receiving a single, 150 mg dose of fosaprepitant and the group receiving oral EMEND were asthenia (loss of strength), constipation, anorexia, diarrhea and nausea.

Source Merck

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