title: A Phase II Study to Evaluate the Efficacy of Ramosetron, Aprepitant, and Dexamethasone in Preventing Cisplatin-Induced Nausea and Vomiting in Chemotherapy-Naïve Cancer Patients.
abstract: OBJECTIVE
  Combination therapy with aprepitant, serotonin receptor antagonist, and steroids improves the complete response rate of both acute and delayed chemotherapy-induced nausea and vomiting (CINV). However, it is not known whether ramosetron is suitable for administration in combination with aprepitant. Therefore, we conducted a multicenter, open-label, prospective, phase II study in order to assess the efficacy and tolerability of combination therapy with ramosetron, aprepitant, and dexamethasone (RAD) for prevention of cisplatin-based CINV in chemotherapy-naïve patients with solid cancers.
  
  
  METHODS
  Forty-one patients with various solid cancers (31 male and 10 female; median age, 59 years) who received treatment with highly emetogenic chemotherapy (median cisplatin dose, 70 mg/m(2); range 50 to 75 mg/m(2)) were enrolled in this study. Oral aprepitant (125 mg on day 1; 80 mg on days 2 and 3), intravenous ramosetron (0.6 mg on day 1), and oral dexamethasone (12 mg on day 1; 8 mg on days 2-4) were administered for prevention of CINV.
  
  
  RESULTS
  The complete response (no emesisand retching and no rescue medication) rate was 94.9% in the acute period (24 hours post-chemotherapy), 92.3% in the delayed period (24-120 hours post-chemotherapy), and 92.3% in the overall period (0-120 hours). The absolute complete response (complete response plus no nausea) rate was 74.4% in the acute period, 51.3% in the delayed period, and 46.2% in the overall period. There were no grade 3 or 4 toxicities related to these antiemetic combinations.
  
  
  CONCLUSIONS
  RAD regimen is a safe and effective antiemetic treatment for prevention of CINV in patients receiving highly emetogenic chemotherapy.
authors.affiliation: Department of Internal Medicine, Hallym University Kangdong Sacred Heart Hospital, Hallym University College of Medicine, Seoul, Korea.
authors.forename: Geundoo
authors.initials: G
authors.lastname: Jang
authors.forename: Hun Ho
authors.initials: HH
authors.lastname: Song
authors.forename: Keon Uk
authors.initials: KU
authors.lastname: Park
authors.forename: Hyeong Su
authors.initials: HS
authors.lastname: Kim
authors.forename: Dae Ro
authors.initials: DR
authors.lastname: Choi
authors.forename: Jung Hye
authors.initials: JH
authors.lastname: Kwon
authors.forename: Ho Young
authors.initials: HY
authors.lastname: Kim
authors.forename: Boram
authors.initials: B
authors.lastname: Han
authors.forename: Jung Han
authors.initials: JH
authors.lastname: Kim
authors.forename: Joo Young
authors.initials: JY
authors.lastname: Jung
authors.forename: Hyo Jung
authors.initials: HJ
authors.lastname: Kim
authors.forename: Dae Young
authors.initials: DY
authors.lastname: Zang
keywords: Aprepitant; Chemotherapy-induced nausea and vomiting; Dexamethasone; Ramosetron