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| |  Aprepitant Reduces Nausea, Vomiting Associated With Emetogenic Preparative Regimens Prior to HSCT: Presented at ASH By Betty S. Riggs NEW ORLEANS -- December 7, 2009 -- Treatment with aprepitant significantly reduced nausea and vomiting associated with highly emetogenic ablative regimens prior to haematopoietic stem cell transplant (HCST), according to a study presented here at the American Society of Hematology (ASH) 51st Annual Meeting and Exposition. Patrick Stiff, MD, Department of Medicine, Loyola University, Maywood, Illinois, reported data from the single centre, randomised, blinded phase 3 study here on December 6. In the study, patients were randomised to receive either placebo (n = 89) or oral aprepitant (n = 90), 125 mg/day on day 1 followed by 80 mg/day during and for 3 days after the preparative regimen was completed. In addition, all patients received oral ondansetron 8 mg every 8hours and intravenous dexamethasone daily during and for 1 day after the preparative regimen. Patients also received blinded doses of dexamethasone (10 mg for placebo and 7.5 mg for aprepitant) due to the known drug interaction between aprepitant and dexamethasone. Lorazepam was permitted for breakthrough nausea and vomiting as needed, and additional antiemetics were allowed if >4 episodes of vomiting occurred in a 12-hour period. The primary endpoint was a complete response, defined as no emesis and no or mild nausea. Other endpoints included major response (1 episode of emesis or moderate nausea); minor response (2-4 episodes of emesis); and failure (>4 episodes of emesis). Clinical evaluations were performed daily during therapy. Significantly more patients in the aprepitant group reported no emesis during the entire period, compared with patients in the placebo group (73.3% vs 22.5%; P < .001). A complete response was achieved by 48.9% of patients in the aprepitant group, compared with 14.6% of patients in the placebo group (P < .001). A major response was observed in 16% of aprepitant-treated patients versus 21.6% of placebo-treated patients (P = .011), a minor response was seen in 2.0% versus 10.3%, respectively (P < .001), and failure was observed in 0.1% versus 2.2% (P < .001). There were no differences in 30-day survival or overall survival between groups. Progression-free survival was 28.3 months for the aprepitant group, compared with 28.6 months for the placebo group (P = .8206). Heartburn was more common in patients receiving aprepitant (12/90), compared with placebo (6/89). Engraftment failure occurred in 3 patients in the placebo arm and in 5 patients in the aprepitant arm. Funding for this study was provided by Merck [Presentation title: Aprepitant vs. Placebo Plus Oral Ondansetron and Dexamethasone for the Prevention of Nausea and Vomiting Associated With Highly Emetogenic Preparative Regimens Prior to Hematopoietic Stem Cell Transplantation: A Prospective, Randomized Double-Blind Phase III Trial. Abstract 2267]
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