title: Pilot study on the efficacy of an ondansetron- versus palonosetron-containing antiemetic regimen prior to highly emetogenic chemotherapy.
abstract: OBJECTIVE
  Nausea and vomiting are among the most feared complications of chemotherapy reported by patients. The objective of this study was to establish the overall complete response (CR; no emesis or use of rescue medication 0-120 h after chemotherapy) with either ondansetron- or palonosetron-containing antiemetic regimens in patients receiving highly emetogenic chemotherapy (HEC).
  
  
  METHODS
  This was a prospective, open-label, randomized, single-center, pilot study that enrolled patients receiving their first cycle of HEC. Patients were randomized to receive either palonosetron 0.25 mg IV (PAD) or ondansetron 24 mg orally (OAD) on day 1 prior to HEC. All patients received oral aprepitant 125 mg on day 1, then 80 mg on days 2 and 3, and oral dexamethasone 12 mg on day 1, then 8 mg on days 2, 3, and 4. Descriptive statistics were used to summarize the data.
  
  
  RESULTS
  A total of 40 patients were enrolled, 20 in each arm. All patients were female, and 39 received doxorubicin/cyclophosphamide chemotherapy for breast cancer. For the primary endpoint, 65 % (95 % CI, 40.8-84.6 %) of patients in the PAD arm and 40 % (95 % CI, 19.1-63.9 %) of patients in the OAD arm achieved an overall CR.
  
  
  CONCLUSIONS
  While CR rates for aprepitant and dexamethasone plus palonosetron or ondansetron-containing regimens have been published previously, this is the first documentation of CR rates with these regimens in the same patient population. These results may be used to design a larger, adequately powered, prospective study comparing these regimens.
authors.affiliation: Pharmacy Department, The Arthur G. James Cancer Hospital and Richard J. Solove Research Institute at The Ohio State University, Columbus, OH, USA, wenzelc@ccf.org.
authors.forename: Candice M
authors.initials: CM
authors.lastname: Wenzell
authors.forename: Michael J
authors.initials: MJ
authors.lastname: Berger
authors.forename: Marlo A
authors.initials: MA
authors.lastname: Blazer
authors.forename: Brooke S
authors.initials: BS
authors.lastname: Crawford
authors.forename: Niesha L
authors.initials: NL
authors.lastname: Griffith
authors.forename: Robert
authors.initials: R
authors.lastname: Wesolowski
authors.forename: Maryam B
authors.initials: MB
authors.lastname: Lustberg
authors.forename: Gary S
authors.initials: GS
authors.lastname: Phillips
authors.forename: Bhuvaneswari
authors.initials: B
authors.lastname: Ramaswamy
authors.forename: Ewa
authors.initials: E
authors.lastname: Mrozek
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Flynn
authors.forename: Charles L
authors.initials: CL
authors.lastname: Shapiro
authors.forename: Rachel M
authors.initials: RM
authors.lastname: Layman
mesh_terms: D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage* / Q000009:adverse effects; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects* / Q000627:therapeutic use; D000077608:Aprepitant; D001943:Breast Neoplasms / Q000188:drug therapy*; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage / Q000009:adverse effects; D004317:Doxorubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000008:administration & dosage* / Q000009:adverse effects; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage / Q000009:adverse effects; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*; D017294:Ondansetron / Q000008:administration & dosage* / Q000009:adverse effects; D000077924:Palonosetron; D010865:Pilot Projects; D011446:Prospective Studies; D011812:Quinuclidines / Q000008:administration & dosage* / Q000009:adverse effects; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D007546:Isoquinolines; D009025:Morpholines; D011812:Quinuclidines; D000077608:Aprepitant; D017294:Ondansetron; D000077924:Palonosetron; D003907:Dexamethasone; D004317:Doxorubicin; D003520:Cyclophosphamide