title: Defining optimal control of chemotherapy-induced nausea and vomiting-based on patients' experience.
abstract: OBJECTIVE
  A considerable challenge when comparing antiemetic trials for chemotherapy-induced nausea and vomiting (CINV) is the large number of outcome measures for nausea and vomiting. The objective of this study is to determine the optimal definition of CINV control from the patients' perspective.
  
  
  METHODS
  Patients with early-stage breast cancer who had received anthracycline-cyclophosphamide-based chemotherapy were surveyed. They were asked about their experiences of CINV and perceptions of different CINV assessment tools.
  
  
  RESULTS
  Of 201 patients approached, 168 (83 %) completed the survey. Patients consistently ranked nausea over vomiting as the "worst side effect from chemotherapy." Despite the use of multi-agent antiemetic regimens, 71 % of patients experienced nausea and 26 % vomiting. Only 57 % of patients with any nausea or vomiting took rescue medications and only then when the symptom was severe. Most (76 %) patients believed that the primary end point of antiemetic trials should include the absence of both nausea and vomiting. Patients felt that CINV should be evaluated for the overall period post chemotherapy (i.e., days 1-5) and not simply the acute (the first 24 h) or delayed (days 2-5) periods.
  
  
  CONCLUSIONS
  Patients strongly favored a CINV end point that includes the absence of both nausea and vomiting. Patients' experience with CINV is underestimated when nausea is not included in composite end points. "Use of rescue medication," a commonly used surrogate for emesis control, is inappropriate as it underestimates nausea. A standardized primary end point that includes nausea is essential if CINV control is to be improved.
authors.affiliation: Division of Medical Oncology and Department of Medicine, University of Ottawa, Ottawa, Canada.
authors.forename: Catalina
authors.initials: C
authors.lastname: Hernandez Torres
authors.affiliation: Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.
authors.forename: Sasha
authors.initials: S
authors.lastname: Mazzarello
authors.affiliation: Division of Medical Oncology and Department of Medicine, University of Ottawa, Ottawa, Canada.
authors.forename: Terry
authors.initials: T
authors.lastname: Ng
authors.affiliation: , Toronto, Canada.
authors.forename: George
authors.initials: G
authors.lastname: Dranitsaris
authors.affiliation: Clinical Epidemiology Program, Ottawa Hospital Research Institute, Ottawa, Canada.
authors.forename: Brian
authors.initials: B
authors.lastname: Hutton
authors.affiliation: Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Smith
authors.affiliation: Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada.
authors.forename: Amy
authors.initials: A
authors.lastname: Munro
authors.affiliation: Division of Medical Oncology and Department of Medicine, University of Ottawa, Ottawa, Canada.
authors.forename: Carmel
authors.initials: C
authors.lastname: Jacobs
authors.affiliation: Division of Medical Oncology and Department of Medicine, University of Ottawa, Ottawa, Canada. mclemons@toh.on.ca.|Cancer Therapeutics Program, Ottawa Hospital Research Institute, Ottawa, Canada. mclemons@toh.on.ca.|Division of Medical Oncology, The Ottawa Hospital Cancer Centre, Box 912, 501 Smyth Road, Ottawa, ON, K1H 8L6, Canada. mclemons@toh.on.ca.
authors.forename: Mark
authors.initials: M
authors.lastname: Clemons
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000009:adverse effects / Q000627:therapeutic use; D000932:Antiemetics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects* / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy*; D003520:Cyclophosphamide / Q000009:adverse effects / Q000627:therapeutic use; D005260:Female; D006801:Humans; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy*; D057240:Patient Preference; D011795:Surveys and Questionnaires; D013997:Time Factors; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy*
chemical_list: D018943:Anthracyclines; D000932:Antiemetics; D000970:Antineoplastic Agents; D003520:Cyclophosphamide
keywords: Breast cancer; CINV; End points; Patient; Perception