title: 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.
abstract: BACKGROUND
  Currently, there is limited data on the prevention of chemotherapy-induced nausea and vomiting (CINV) in Indian patients.
  
  
  OBJECTIVE
  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.
  
  
  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.
  
  
  METHODS
  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.
authors.affiliation: Medical Oncology, SEAROC Cancer Center, S.K. Soni Hospital Premise, Jaipur, India.
authors.forename: A
authors.initials: A
authors.lastname: Maru
authors.forename: V P
authors.initials: VP
authors.lastname: Gangadharan
authors.forename: C J
authors.initials: CJ
authors.lastname: Desai
authors.forename: R K
authors.initials: RK
authors.lastname: Mohapatra
authors.forename: A D
authors.initials: AD
authors.lastname: Carides
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000008:administration & dosage; D000077608:Aprepitant; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects*; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D007194:India; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage*; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy; D009369:Neoplasms / Q000188:drug therapy* / Q000473:pathology
chemical_list: D000932:Antiemetics; D009025:Morpholines; D000077608:Aprepitant; C579707:fosaprepitant; D002945:Cisplatin