title: Aprepitant triple therapy for the prevention of chemotherapy-induced nausea and vomiting following high-dose cisplatin in Chinese patients: a randomized, double-blind, placebo-controlled phase III trial.
abstract: OBJECTIVE
  Aprepitant, an oral neurokinin-1 receptor antagonist, has demonstrated improved control of chemotherapy-induced nausea and vomiting (CINV) in previous studies. This is the first phase III study to evaluate the efficacy and tolerability of aprepitant in patients receiving highly emetogenic chemotherapy (HEC) in Asian countries.
  
  
  METHODS
  This multicenter, double-blind, placebo-controlled trial assessed the prevention of CINV during the acute phase (AP), delayed phase (DP), and overall phase (OP). Patients receiving HEC were randomized to either an aprepitant group (day 1, aprepitant 125 mg; days 2-3, aprepitant 80 mg) or a standard therapy group (days 1-3, placebo). Both groups received intravenous granisetron and oral dexamethasone. The primary end point was complete response (CR; no emesis and no use of rescue therapy) during the OP.
  
  
  RESULTS
  Of the 421 randomized patients, 411 (98%) were assessable for efficacy; 69.6% (142/204) and 57.0% (118/207) of patients reported CR during the OP in the aprepitant and standard therapy groups, respectively (P = 0.007). CR rates in the aprepitant group were higher during the DP (74.0% vs. 59.4%, P = 0.001) but were similar during the AP (79.4% vs. 79.3%, P = 0.942). Toxicity and adverse events were comparable in both groups.
  
  
  CONCLUSIONS
  The addition of aprepitant to standard antiemetic treatment regimens for Chinese patients undergoing HEC provided superior CINV prevention and was well tolerated.
authors.affiliation: Department of Medical Oncology, Sun Yat-sen University Cancer Center, 651 Dongfeng Road East, Guangzhou, 510060, People's Republic of China.
authors.forename: Zhihuang
authors.initials: Z
authors.lastname: Hu
authors.forename: Ying
authors.initials: Y
authors.lastname: Cheng
authors.forename: Hongyu
authors.initials: H
authors.lastname: Zhang
authors.forename: Caicun
authors.initials: C
authors.lastname: Zhou
authors.forename: Baohui
authors.initials: B
authors.lastname: Han
authors.forename: Yiping
authors.initials: Y
authors.lastname: Zhang
authors.forename: Cheng
authors.initials: C
authors.lastname: Huang
authors.forename: Jianhua
authors.initials: J
authors.lastname: Chang
authors.forename: Xiangqun
authors.initials: X
authors.lastname: Song
authors.forename: Jun
authors.initials: J
authors.lastname: Liang
authors.forename: Houjie
authors.initials: H
authors.lastname: Liang
authors.forename: Chunxue
authors.initials: C
authors.lastname: Bai
authors.forename: Shiying
authors.initials: S
authors.lastname: Yu
authors.forename: Jia
authors.initials: J
authors.lastname: Chen
authors.forename: Jie
authors.initials: J
authors.lastname: Wang
authors.forename: Hongming
authors.initials: H
authors.lastname: Pan
authors.forename: Denesh K
authors.initials: DK
authors.lastname: Chitkara
authors.forename: Darcy A
authors.initials: DA
authors.lastname: Hille
authors.forename: Li
authors.initials: L
authors.lastname: Zhang
mesh_terms: D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000077608:Aprepitant; D044466:Asian People; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects* / Q000627:therapeutic use; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000009:adverse effects / Q000627:therapeutic use*; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents; D009025:Morpholines; D000077608:Aprepitant; D002945:Cisplatin