Merck Sharp & Dohme Limited (“MSD”) announced the results from a new trial comparing an anti-emetic regimen containing a single IV dose of fosaprepitant dimeglumine to one with three days of oral aprepitant.
The study found that the anti-emetic regimen of fosaprepitant dimeglumine administered as a single intravenous (IV) 150mg dose on Day 1 in combination with a 5-HT3 antagonist, and dexamethasone administered over 4 days, is non-inferior to a three-day regimen of oral aprepitant, in combination with a 5-HT3 antagonist on Day 1 and dexamethasone on days 1 to 4, for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients receiving a first cycle of cisplatin-based chemotherapy.
CINV is one of the most feared side effects of chemotherapy; If it is inadequately controlled, it adds to the morbidity and cost of therapy and impairs quality of life. The main clinical syndromes are acute CINV, which occurs within 24 hours of moderate or highly emetogenic chemotherapy and delayed CINV which occurs at least 24 hours after dosing.
In this study patients received one of the following regimens:1
- A single, IV, 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 OR
- A three-day oral regimen of aprepitant consisting of aprepitant 125 mg orally, ondansetron 32 mg IV, and dexamethasone 12 mg orally on Day 1, aprepitant 80 mg orally once daily on Days 2 and 3, and dexamethasone 8 mg orally once daily on Days 2 through 4.
In the study, 71.9 percent of patients in the fosaprepitant group achieved a complete response* compared to 72.3 percent of those in the aprepitant group.1 In addition, 74.3 percent of patients in the fosaprepitant group achieved a complete response in the delayed phase compared to 74.2 percent of patients in the aprepitant group.
Andrew Wilson-Webb, Chief Executive of Rarer Cancer Foundation said ‘Nausea and vomiting is one of the most dreaded side-effects of chemotherapy in cancer patients. It can significantly impact quality of life and daily living including eating, getting enough sleep, participating in social activities and work. Another potential treatment option to help prevent chemotherapy induced nausea and vomiting offering greater patient choice and flexibility is welcomed’.
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 aprepitant over 3 days, were asthenia (weakness, loss of strength), constipation, anorexia, diarrhoea and nausea.