title: A randomized study of aprepitant, ondansetron and dexamethasone for chemotherapy-induced nausea and vomiting in Chinese breast cancer patients receiving moderately emetogenic chemotherapy.
abstract: OBJECTIVE
  This is a single center, randomized, double-blind placebo-controlled study to evaluate the NK(1)-receptor antagonist, aprepitant, in Chinese breast cancer patients. The primary objective was to compare the efficacy of aprepitant-based antiemetic regimen and standard antiemetic regimen for the prevention of chemotherapy-induced nausea and vomiting (CINV) in patients who received moderately emetogenic chemotherapy. The secondary objective was to compare the patient-reported quality of life in these two groups of patients.
  
  
  METHODS
  Eligible breast cancer patients were chemotherapy-naive and treated with adjuvant AC chemotherapy (i.e. doxorubicin 60 mg/m(2) and cyclophosphamide 600 mg/m(2)). Patients were randomly assigned to either an aprepitant-based regimen (day 1, aprepitant 125 mg, ondansetron 8 mg, and dexamethasone 12 mg before chemotherapy and ondansetron 8 mg 8 h later; days 2 through 3, aprepitant 80 qd) or a control arm which consisted of standard regimen (day 1, ondansetron 8 mg and dexamethasone 20 mg before chemotherapy and ondansetron 8 mg 8 h later; days 2 through 3, ondansetron 8 mg bid). Data on nausea, vomiting, and use of rescue medication were collected with a self-report diary, patients quality of life were assessed by self-administered Functional Living Index-Emesis (FLIE).
  
  
  RESULTS
  Of 127 patients randomized, 124 were assessable. For CINV in Cycle 1 AC, there was no significant difference in the proportion of patients with reported complete response, complete protection, total control, 'no vomiting', 'no significant nausea' and 'no nausea'. The requirement of rescue medication appears to be lesser in patients treated with the aprepitant-based regimen compared to those with the standard regimen (11% vs. 20%; P = 0.06). Assessment of FLIE revealed that while there was no difference in the nausea domain and the total score between the two groups; however, patients receiving standard antiemetic regimen had significantly worse quality of life in the vomiting domain (mean score [SD] = 23.99 [30.79]) when compared with those who received the aprepitant-based regimen (mean score [SD] = 3.40 [13.18]) (P = 0.0002). Both treatments were generally well tolerated. Patients treated with the aprepitant-based regimen had a significantly lower incidence of neutropenia (53.2% vs. 35.5%, P = 0.0468), grade >or= 3 neutropenia (21.0% vs. 45.2, P = 0.0042) and delay in subsequent cycle of chemotherapy (8.1% vs. 27.4%, P = 0.0048).
  
  
  CONCLUSIONS
  The aprepitant regimen appears to reduce the requirement of rescue medication when compared with the control regimen for prevention of CINV in patients receiving both an anthracycline and cyclophosphamide, and is associated with a better quality of life during adjuvant AC chemotherapy.
authors.affiliation: Department of Clinical Oncology, Prince of Wales Hospital, Chinese University of Hong Kong, Shatin, NT, Hong Kong. winnieyeo@cuhk.edu.hk
authors.forename: Winnie
authors.initials: W
authors.lastname: Yeo
authors.forename: F K F
authors.initials: FK
authors.lastname: Mo
authors.forename: J J S
authors.initials: JJ
authors.lastname: Suen
authors.forename: W M
authors.initials: WM
authors.lastname: Ho
authors.forename: S L
authors.initials: SL
authors.lastname: Chan
authors.forename: W
authors.initials: W
authors.lastname: Lau
authors.forename: J
authors.initials: J
authors.lastname: Koh
authors.forename: W K
authors.initials: WK
authors.lastname: Yeung
authors.forename: W H
authors.initials: WH
authors.lastname: Kwan
authors.forename: K K C
authors.initials: KK
authors.lastname: Lee
authors.forename: T S K
authors.initials: TS
authors.lastname: Mok
authors.forename: A N Y
authors.initials: AN
authors.lastname: Poon
authors.forename: K C
authors.initials: KC
authors.lastname: Lam
authors.forename: E K
authors.initials: EK
authors.lastname: Hui
authors.forename: B
authors.initials: B
authors.lastname: Zee
mesh_terms: D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000009:adverse effects; D000077608:Aprepitant; D001943:Breast Neoplasms / Q000188:drug therapy*; D018270:Carcinoma, Ductal, Breast / Q000188:drug therapy; D002681:China; D003907:Dexamethasone / Q000008:administration & dosage; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage*; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy*; D017294:Ondansetron / Q000008:administration & dosage*; D011788:Quality of Life; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy*
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents; D009025:Morpholines; D000077608:Aprepitant; D017294:Ondansetron; D003907:Dexamethasone