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.

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dc.contributor.authorMaru, A
dc.contributor.authorGangadharan, V P
dc.contributor.authorDesai, C J
dc.contributor.authorMohapatra, R K
dc.contributor.authorCarides, A D
dc.date.accessioned2014-12-29T10:17:48Z
dc.date.available2014-12-29T10:17:48Z
dc.date.issued2013-10
dc.description.abstractContext: 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.en_US
dc.identifier.citationMaru 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.en_US
dc.identifier.urihttps://imsear.searo.who.int/handle/123456789/154279
dc.language.isoenen_US
dc.source.urihttps://www.indianjcancer.com/article.asp?issn=0019-509X;year=2013;volume=50;issue=4;spage=285;epage=291;aulast=Maruen_US
dc.subjectAntiemetic therapy, aprepitanten_US
dc.subjectchemotherapy-induced nausea anden_US
dc.subjectvomitingen_US
dc.subjectfosaprepitanten_US
dc.subjectIndian populationen_US
dc.subjectnoninferiorityen_US
dc.subject.meshAdult
dc.subject.meshAged
dc.subject.meshAsian Continental Ancestry Group
dc.subject.meshAfrican Continental Ancestry Group
dc.subject.meshAntiemetics --therapeutics
dc.subject.meshCisplatin --adverse effects
dc.subject.meshContinental Population Groups
dc.subject.meshDouble-Blind Method
dc.subject.meshFemale
dc.subject.meshHawaii--ethnology
dc.subject.meshHumans
dc.subject.meshIndians, North American
dc.subject.meshMale
dc.subject.meshMiddle Aged
dc.subject.meshMorpholines --administration & dosage
dc.subject.meshMorpholines --therapeutic use
dc.subject.meshNeoplasms --drug therapy
dc.subject.meshNausea --chemically induced
dc.subject.meshNausea --drug therapy
dc.subject.meshNausea --prevention & control
dc.subject.meshOceanic Ancestry Group
dc.subject.meshVomiting --chemically induced
dc.subject.meshVomiting --drug therapy
dc.subject.meshVomiting --prevention & control
dc.titleA Phase 3, randomized, double-blind study of single-dose fosaprepitant for prevention of cisplatin-induced nausea and vomiting: Results of an Indian population subanalysis.en_US
dc.typeArticleen_US
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