title: Effectiveness of aprepitant in addition to ondansetron in the prevention of nausea and vomiting caused by fractionated radiotherapy to the upper abdomen (AVERT).
abstract: Despite a lower risk of nausea and vomiting in patients receiving radiotherapy to the upper abdomen (UA-RINV) with prophylactic 5-HT3 antagonist therapy, patients can still experience UA-RINV. The aim of this multicenter phase II study was to assess effectiveness, safety, and tolerability of protracted dual NK1-receptor and 5-HT3 antagonist prophylaxis against UA-RINV.
  
  
  
  Patients receiving fractionated radiotherapy with radiosensitizing chemotherapy received oral ondansetron 8 mg po q12 h and aprepitant 125/80/80 mg on a Monday, Wednesday, Friday schedules throughout radiotherapy. The primary outcome was complete response (CR) defined as no vomiting or rescue therapy during the entire observation period of radiotherapy (OP). Nausea, vomiting, and use of rescue medication were recorded in a modified version of the MASCC antiemesis tool completed twice weekly.
  
  
  
  Fifty-five patients were enrolled at 5 sites, 52 of whom were evaluable. 57.7% of patients (30/52, 95% CI 43.2-71.3%) achieved CR on study, with 73.1% (38/52, 95% CI 59.0-84.4%) who did not vomit, and 71.2% (37/52, 95% CI 56.9-82.9%) who did not use rescue medication during the OP. Overall, participants vomited or experienced significant nausea (SN) for an average of 6.8% (95% CI 11.4-21.0) and 8.4% (95% CI 4.2-12.7%) of time on study, respectively. Nausea was common with 32 (61.5%) reporting SN at any time during the OP.
  
  
  
  UA-RINV remains an important morbidity despite the advent of modern radiotherapy. Aprepitant and ondansetron as dosed in this trial was not superior to standard ondansetron monotherapy.
authors.affiliation: University of Vermont Cancer Center, Given Building, E214C, 89 Beaumont Ave, Burlington, VT, 05405, USA. steven.ades@uvm.edu.
authors.forename: Steven
authors.identifier: 0000-0002-7077-1842
authors.initials: S
authors.lastname: Ades
authors.affiliation: Mayo Clinic, Scottsdale, AZ, USA.
authors.forename: M
authors.initials: M
authors.lastname: Halyard
authors.affiliation: University of Vermont Cancer Center, Given Building, E214C, 89 Beaumont Ave, Burlington, VT, 05405, USA.
authors.forename: K
authors.initials: K
authors.lastname: Wilson
authors.affiliation: Medical Biostatistics, University of Vermont, Burlington, VT, USA.
authors.forename: T
authors.initials: T
authors.lastname: Ashikaga
authors.affiliation: University of Vermont Cancer Center, Given Building, E214C, 89 Beaumont Ave, Burlington, VT, 05405, USA.
authors.forename: R
authors.initials: R
authors.lastname: Heimann
authors.affiliation: University of Rochester, Rochester, NY, USA.
authors.forename: S
authors.initials: S
authors.lastname: Kumar
authors.affiliation: Wake Forest University Baptist Medical Center, Winston-Salem, NC, USA.
authors.forename: W
authors.initials: W
authors.lastname: Blackstock
mesh_terms: D000005:Abdomen / Q000528:radiation effects*; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D000077608:Aprepitant; D019583:Dose Fractionation, Radiation; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*; D017294:Ondansetron / Q000008:administration & dosage / Q000494:pharmacology / Q000627:therapeutic use*; D011878:Radiotherapy / Q000009:adverse effects*; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D009025:Morpholines; D000077608:Aprepitant; D017294:Ondansetron
keywords: Aprepitant; Nausea; Ondansetron; Prophylaxis; Radiotherapy; Vomiting