Maru, AGangadharan, V PDesai, C JMohapatra, R KCarides, A D2014-12-292014-12-292013-10Maru A, Gangadharan V P, Desai C J, Mohapatra R K, Carides A D. A Phase 3, randomized, double-blind study of single-dose fosaprepitant for prevention of cisplatin-induced nausea and vomiting: Results of an Indian population subanalysis. Indian Journal of Cancer. 2013 Oct-Dec; 50(4): 285-291.http://imsear.searo.who.int/handle/123456789/154279Context: Currently, there is limited data on the prevention of chemotherapy-induced nausea and vomiting (CINV) in Indian patients. Aims: This post hoc study assessed the efficacy and safety of fosaprepitant compared with aprepitant for prevention of CINV in the Indian population. A subgroup analysis was performed from data collected in a phase 3 study of intravenous (IV) fosaprepitant or oral aprepitant, plus the 5-HT 3 antagonist ondansetron and the corticosteroid dexamethasone, in cisplatin-naοve patients with solid malignancies. Materials and Methods: Patients scheduled to receive cisplatin (≥70 mg/m 2 ) were administered a single IV dose of fosaprepitant dimeglumine (150 mg) on day 1 or a 3-day dosing regimen of oral aprepitant (day 1:125 mg, days 2 and 3:80 mg) with standard doses of ondansetron and dexamethasone. Patients recorded nausea and/or vomiting episodes and their use of rescue medication and were monitored for adverse events (AEs) and tolerability. Statistical Analysis Used: Differences in response rates between fosaprepitant and aprepitant were calculated using the Miettinen and Nurminen method. Results: In the Indian subpopulation (n = 372), efficacy was similar for patients in both the fosaprepitant or aprepitant groups; complete response in the overall, acute, and delayed phases and no vomiting in all phases were approximately 4 percentage points higher in the fosaprepitant group compared with the aprepitant group. Fosaprepitant was generally well-tolerated; common AEs were similar to oral aprepitant. Conclusions: IV fosaprepitant is as safe and effective as oral aprepitant in the Indian subpopulation and offers an alternative to the oral formulation.enAntiemetic therapy, aprepitantchemotherapy-induced nausea andvomitingfosaprepitantIndian populationnoninferiorityAdultAgedAsian Continental Ancestry GroupAfrican Continental Ancestry GroupAntiemetics --therapeuticsCisplatin --adverse effectsContinental Population GroupsDouble-Blind MethodFemaleHawaii--ethnologyHumansIndians, North AmericanMaleMiddle AgedMorpholines --administration & dosageMorpholines --therapeutic useNeoplasms --drug therapyNausea --chemically inducedNausea --drug therapyNausea --prevention & controlOceanic Ancestry GroupVomiting --chemically inducedVomiting --drug therapyVomiting --prevention & controlArticle