title: A randomised, placebo-controlled, double-blind study of aprepitant in nondrinking women younger than 70 years receiving moderately emetogenic chemotherapy.
abstract: BACKGROUND
  We evaluated the efficacy of aprepitant plus granisetron and an increased dose of dexamethasone in selected patients undergoing moderately emetogenic chemotherapy (MEC).
  
  
  METHODS
  Nondrinking women <70 years undergoing MEC were randomly assigned to aprepitant (day 1, 125 mg; days 2 and 3, 80 mg) or placebo. Dexamethasone on days 1-3 was 12, 4, and 4 mg with aprepitant and 20, 8, and 8 mg with placebo. The primary end point was complete response (CR; no emesis or rescue therapy) during 120 h of the first cycle. Logistic regression analysis was performed to identify predictors of overall CR.
  
  
  RESULTS
  Of the 94 patients enrolled, 91 were assessable. Most received carboplatin-based chemotherapy. In the aprepitant (n=45) and placebo (n=46) groups, the overall, acute (day 1), and delayed (days 2-5) CR rates were 62% and 52%, 98% and 96%, and 62% and 52%, respectively. Although not statistically significant, the overall CR rate was 10% higher in the aprepitant group. Both regimens were well tolerated. On multivariate analysis, advanced ovarian cancer (OR, 0.26 (0.10-0.72)) was independently associated with a lower CR.
  
  
  CONCLUSIONS
  Even with an increased dose of dexamethasone, aprepitant seemed more effective than placebo in these selected patients undergoing MEC; however, delayed phase management remains a significant problem.
authors.affiliation: Medical Oncology, Hyogo Cancer Center, Akashi, Japan. tanioka@hp.pref.hyogo.jp
authors.forename: M
authors.initials: M
authors.lastname: Tanioka
authors.forename: A
authors.initials: A
authors.lastname: Kitao
authors.forename: K
authors.initials: K
authors.lastname: Matsumoto
authors.forename: N
authors.initials: N
authors.lastname: Shibata
authors.forename: S
authors.initials: S
authors.lastname: Yamaguchi
authors.forename: K
authors.initials: K
authors.lastname: Fujiwara
authors.forename: H
authors.initials: H
authors.lastname: Minami
authors.forename: N
authors.initials: N
authors.lastname: Katakami
authors.forename: S
authors.initials: S
authors.lastname: Morita
authors.forename: S
authors.initials: S
authors.lastname: Negoro
mesh_terms: D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D000077608:Aprepitant; D002166:Camptothecin / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D016190:Carboplatin / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D016889:Endometrial Neoplasms / Q000188:drug therapy; D005260:Female; D017829:Granisetron / Q000627:therapeutic use; D006801:Humans; D000077146:Irinotecan; D016015:Logistic Models; D008875:Middle Aged; D009025:Morpholines / Q000627:therapeutic use*; D009369:Neoplasms / Q000188:drug therapy*; D010051:Ovarian Neoplasms / Q000188:drug therapy; D013695:Temperance; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D000077608:Aprepitant; D002166:Camptothecin; D016190:Carboplatin; D003907:Dexamethasone; D017829:Granisetron; D000077146:Irinotecan; D009025:Morpholines