title: Risk Model-Guided Antiemetic Prophylaxis vs Physician's Choice in Patients Receiving Chemotherapy for Early-Stage Breast Cancer: A Randomized Clinical Trial.
abstract: OBJECTIVE
  Despite multiple patient-centered factors being associated with the risk of chemotherapy-induced nausea and vomiting (CINV), these factors are rarely considered when making antiemetic recommendations.
  
  
  OBJECTIVE
  To compare risk model-guided (RMG) antiemetic prophylaxis with physician's choice (PC) in patients receiving chemotherapy for early-stage breast cancer.
  
  
  METHODS
  A randomized clinical trial of 324 patients with early-stage breast cancer undergoing chemotherapy (cyclophosphamide and an anthracycline) for the first time at 2 specialty cancer care centers in Ottawa from April 10, 2012, to September 2, 2014. Patients were randomized to either the RMG arm (n = 154) or the PC control arm (n = 170). Prior to each cycle of chemotherapy patients in the RMG group were categorized as low or high risk for CINV, and their antiemetic treatments were adjusted accordingly.
  
  
  METHODS
  Patients considered to be at low risk received standard dexamethasone and a 5-HT3 antagonist, while those at high risk also received aprepitant with or without olanzapine, based on their risk level. The PC control group received antiemetic agents according to the treating physician's discretion.
  
  
  METHODS
  The primary end points were control of both nausea and vomiting in the acute posttreatment period (first 24 hours after therapy) and in the delayed posttreatment period (days 2-5 after therapy).
  
  
  RESULTS
  The total numbers of chemotherapy cycles delivered in the RMG and PC control groups were 497 and 551 respectively. In the acute period, significantly more patients in the RMG group reported no nausea (53.7% [95% CI, 49.2%-58.1%] vs 41.6% [95% CI, 37.4%-45.3%]; P < .001) and no vomiting (91.8% [95% CI, 89.0%-94.0%] vs 82.2% [95% CI, 78.8%-85.3%]; P < .001) compared with the PC control group. Similarly, significantly more patients in the RMG group reported no nausea (39.6% [95% CI, 35.3%-44.1%] vs 30.7% [95% CI, 26.8%-34.7%]; P = .01) and no vomiting (87.1% [95% CI, 83.8%-90.0%) vs 78.0% [95% CI, 74.3%-81.4%]; P < .001) in the delayed period respectively.
  
  
  CONCLUSIONS
  In this trial, the RMG antiemetic prophylaxis led to improved control of acute and delayed CINV compared with physician's choice of therapy.
  
  
  BACKGROUND
  clinicaltrials.gov Identifier: NCT01913990.
authors.affiliation: Division of Medical Oncology, Department of Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada2Ottawa Hospital Research Institute, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Mark
authors.initials: M
authors.lastname: Clemons
authors.affiliation: Division of Medical Oncology, Department of Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.
authors.forename: Nathaniel
authors.initials: N
authors.lastname: Bouganim
authors.affiliation: Ottawa Hospital Research Institute, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Smith
authors.affiliation: Ottawa Hospital Research Institute, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Sasha
authors.initials: S
authors.lastname: Mazzarello
authors.affiliation: Ottawa Hospital Research Institute, Department of Medicine, University of Ottawa, Ottawa, Ontario, Canada.
authors.forename: Lisa
authors.initials: L
authors.lastname: Vandermeer
authors.affiliation: Division of Medical Oncology, Department of Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.
authors.forename: Roanne
authors.initials: R
authors.lastname: Segal
authors.affiliation: Division of Medical Oncology, Department of Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.
authors.forename: Susan
authors.initials: S
authors.lastname: Dent
authors.affiliation: Division of Medical Oncology, Department of Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.
authors.forename: Stan
authors.initials: S
authors.lastname: Gertler
authors.affiliation: Division of Medical Oncology, Department of Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.
authors.forename: Xinni
authors.initials: X
authors.lastname: Song
authors.affiliation: Division of Medical Oncology, Department of Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.
authors.forename: Paul
authors.initials: P
authors.lastname: Wheatley-Price
authors.affiliation: Division of Medical Oncology, Department of Medicine, The Ottawa Hospital, Ottawa, Ontario, Canada.
authors.forename: George
authors.initials: G
authors.lastname: Dranitsaris
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000009:adverse effects; D000932:Antiemetics / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001569:Benzodiazepines / Q000008:administration & dosage; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D002755:Choice Behavior; D003520:Cyclophosphamide / Q000009:adverse effects; D003661:Decision Support Techniques; D003907:Dexamethasone / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D009367:Neoplasm Staging; D000077152:Olanzapine; D017294:Ondansetron / Q000008:administration & dosage; D009864:Ontario; D018579:Patient Selection; D010818:Practice Patterns, Physicians'; D011237:Predictive Value of Tests; D018570:Risk Assessment; D012307:Risk Factors; D013997:Time Factors; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
chemical_list: D018943:Anthracyclines; D000932:Antiemetics; D001569:Benzodiazepines; D017294:Ondansetron; D003907:Dexamethasone; D003520:Cyclophosphamide; D000077152:Olanzapine