title: Efficacy and safety of single-dose fosaprepitant in the prevention of chemotherapy-induced nausea and vomiting in patients receiving high-dose cisplatin: a multicentre, randomised, double-blind, placebo-controlled phase 3 trial.
abstract: BACKGROUND
  We evaluated the efficacy and safety of single-dose fosaprepitant in combination with intravenous granisetron and dexamethasone.
  
  
  METHODS
  Patients receiving chemotherapy including cisplatin (≥70 mg/m(2)) were eligible. A total of 347 patients (21% had received cisplatin with vomiting) were enrolled in this trial to receive the fosaprepitant regimen (fosaprepitant 150 mg, intravenous, on day 1 in combination with granisetron, 40 μg/kg, intravenous, on day 1 and dexamethasone, intravenous, on days 1-3) or the control regimen (placebo plus intravenous granisetron and dexamethasone). The primary end point was the percentage of patients who had a complete response (no emesis and no rescue therapy) over the entire treatment course (0-120 h).
  
  
  RESULTS
  The percentage of patients with a complete response was significantly higher in the fosaprepitant group than in the control group (64% versus 47%, P = 0.0015). The fosaprepitant regimen was more effective than the control regimen in both the acute (0-24 h postchemotherapy) phase (94% versus 81%, P = 0.0006) and the delayed (24-120 h postchemotherapy) phase (65% versus 49%, P = 0.0025).
  
  
  CONCLUSIONS
  Single-dose fosaprepitant used in combination with granisetron and dexamethasone was well-tolerated and effective in preventing chemotherapy-induced nausea and vomiting in patients receiving highly emetogenic cancer chemotherapy, including high-dose cisplatin.
authors.affiliation: Department of Respiratory Medicine, Aichi Cancer Center Aichi Hospital, Okazaki, Japan. hsaito@acc-aichi.com
authors.forename: H
authors.initials: H
authors.lastname: Saito
authors.forename: H
authors.initials: H
authors.lastname: Yoshizawa
authors.forename: K
authors.initials: K
authors.lastname: Yoshimori
authors.forename: N
authors.initials: N
authors.lastname: Katakami
authors.forename: N
authors.initials: N
authors.lastname: Katsumata
authors.forename: M
authors.initials: M
authors.lastname: Kawahara
authors.forename: K
authors.initials: K
authors.lastname: Eguchi
mesh_terms: D000328:Adult; D000368:Aged; D000077608:Aprepitant; D002945:Cisplatin / Q000008:administration & dosage / Q000633:toxicity*; D003907:Dexamethasone / Q000008:administration & dosage; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions; D005260:Female; D017829:Granisetron / Q000008:administration & dosage; D006801:Humans; 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; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy*
chemical_list: D000077608:Aprepitant; D002945:Cisplatin; D003907:Dexamethasone; D017829:Granisetron; D009025:Morpholines; C579707:fosaprepitant