title: Single dose of palonosetron plus dexamethasone to control nausea, vomiting and to warrant an adequate food intake in patients treated with highly emetogenic chemotherapy (HEC). Preliminary results.
abstract: BACKGROUND
  The aim of our study was to evaluate the efficacy of a single-dose palonosetron plus dexamethasone to control emesis in patients (pts) receiving HEC. Moreover, we evaluated the amount of their food intake (FI) in the week following therapy, in order to measure any reduction of calories consumption related to Chemotherapy-induced nausea and vomiting (CINV).
  
  
  METHODS
  Patients affected with advanced cancer were treated with palonosetron 250 mcg plus dexamethasone 20 mg before HEC. Nausea, vomiting, and FI were monitored by a 7-day diary. Complete Response (CR: no vomiting and no rescue therapy) was the primary endpoint, Complete Control (CC: CR and no more than mild nausea) and the evaluation of FI were the secondary endpoints. The endpoints were evaluated during the acute (0-24 h), the delayed (25-168 h) and overall (0-168 h) phases.
  
  
  RESULTS
  Thirty-five patients were enrolled; 85.7% and 82.9% of patients achieved CR and CC respectively, during the acute phase; 82.9% and 77.1% of patients achieved CR and CC, during the delayed phase; 80% and 77.1% of patients achieved CR and CC, during the overall phase. During the acute phase, patients with a CC without nausea had a median daily FI of 1,575 kcal, whereas patients with CC and presence of mild nausea had a median daily FI of 1,040 kcal (-535 kcal; p < 0.0001).
  
  
  CONCLUSIONS
  Our preliminary results confirm the efficacy of a single-dose palonosetron plus dexamethasone to prevent both acute and delayed nausea and vomiting. Moreover, the efficacy of palonosetron in nausea and vomiting control seems to warrant adequate caloric intake in these patients.
authors.affiliation: Oncology Unit, Vito Fazzi Hospital, Lecce, Italy. vitolorusso@inwind.it
authors.forename: V
authors.initials: V
authors.lastname: Lorusso
authors.forename: A
authors.initials: A
authors.lastname: Spedicato
authors.forename: L
authors.initials: L
authors.lastname: Petrucelli
authors.forename: V
authors.initials: V
authors.lastname: Saracino
authors.forename: M
authors.initials: M
authors.lastname: Giampaglia
authors.forename: T
authors.initials: T
authors.lastname: Perrone
mesh_terms: D000368:Aged; D000932:Antiemetics / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D003907:Dexamethasone / Q000627:therapeutic use*; D004359:Drug Therapy, Combination; D004435:Eating / Q000187:drug effects; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control; D009369:Neoplasms / Q000188:drug therapy; D000077924:Palonosetron; D011446:Prospective Studies; D011812:Quinuclidines / Q000627:therapeutic use*; D012702:Serotonin Antagonists / Q000627:therapeutic use*; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents; D007546:Isoquinolines; D011812:Quinuclidines; D012702:Serotonin Antagonists; D000077924:Palonosetron; D003907:Dexamethasone