title: Casopitant improves the quality of life in patients receiving highly emetogenic chemotherapy.
abstract: OBJECTIVE
  The control of chemotherapy-induced nausea and vomiting (CINV) is critical in preventing poor health outcomes and increasing patient quality of life. The objective of this study was to evaluate the impact of the addition of casopitant to dual-combination therapy of dexamethasone and ondansetron on quality of life in patients receiving highly emetogenic chemotherapy (HEC).
  
  
  METHODS
  In a multicenter, double-blind, randomized, placebo-controlled, add-on trial (N = 810), patients were randomized to intravenous (IV) ondansetron/dexamethasone alone (control) or in combination with either a single 150-mg oral dose of casopitant or 3-day IV/oral casopitant. Quality of life was assessed as impact of nausea and vomiting on daily life using the Functional Living Index Emesis (FLIE) questionnaire. Patients completed the FLIE questionnaire at baseline prior to receiving chemotherapy and after completion of the first cycle of HEC.
  
  
  RESULTS
  Patients in the single oral dose and 3-day IV/oral casopitant groups scored higher mean total FLIE scores (115.7 and 114.0, respectively; p ≤ 0.0332) than patients in the control group (107.5), indicating that casopitant patients experienced less impact from nausea and vomiting on daily life. The overall absolute difference in the proportion of patients reporting CINV with no impact on daily life between the single oral casopitant group and the control group was 13%; the difference between the 3-day IV/oral casopitant group and the control group was 14%.
  
  
  CONCLUSIONS
  The addition of casopitant to ondansetron and dexamethasone in patients receiving HEC was significantly more effective in reducing the impact of nausea and vomiting on all daily life activities as assessed by the FLIE compared with ondansetron/dexamethasone dual therapy.
authors.affiliation: Division of Medical Oncology, "S.G. Moscati" Hospital, Contrada Amoretta, 83100 Avellino, Italy. cgridelli@libero.it
authors.forename: Cesare
authors.initials: C
authors.lastname: Gridelli
authors.forename: Amin M
authors.initials: AM
authors.lastname: Haiderali
authors.forename: Mark W
authors.initials: MW
authors.lastname: Russo
authors.forename: Linda M
authors.initials: LM
authors.lastname: Blackburn
authors.forename: Konstantinos
authors.initials: K
authors.lastname: Lykopoulos
mesh_terms: D000203:Activities of Daily Living; D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000932:Antiemetics / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D003907:Dexamethasone / Q000627:therapeutic use; D004311:Double-Blind Method; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D009369:Neoplasms / Q000188:drug therapy; D017294:Ondansetron / Q000627:therapeutic use; D010879:Piperazines / Q000008:administration & dosage*; D010880:Piperidines / Q000008:administration & dosage*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*; D055815:Young Adult; D014508:Urea
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents; D003907:Dexamethasone; D017294:Ondansetron; D010879:Piperazines; D010880:Piperidines; C531951:casopitant; D014508:Urea