title: Results of a 7-day aprepitant schedule for the prevention of nausea and vomiting in 5-day cisplatin-based germ cell tumor chemotherapy.
abstract: OBJECTIVE
  The purpose of this study was to determine the efficacy of adding a 7-day aprepitant schedule to a 5HT3 receptor antagonist and dexamethasone for patients with germ cell tumors receiving first-line 5-day cisplatin-based chemotherapy.
  
  
  METHODS
  In a single-arm, open-label, multi-center, phase 2 trial, chemo-naive patients received aprepitant 125 mg PO (per oral) on day 1 and 80 mg PO on days 2 to 7, a 5HT3 receptor antagonist on days 1 to 5, and dexamethasone 8 mg on days 1 to 8. The primary endpoint was no emesis (vomiting or dry retching) during days 1 to 7 of cycle 1.
  
  
  RESULTS
  Fifty patients were recruited. For cycle 1, proportions reporting no emesis on day 1, no emesis on days 1 to 7, no nausea on day 1, and no nausea on days 1 to 7 were 96, 82, 71, and 27%, respectively. The efficacy was maintained in all cycles with over 80% of patients reporting no emesis on any given day of any given cycle. Emesis was more common on days 4 to 7 (68% episodes) than on days 1 to 3 (32% episodes). Over any 24-h period, 49% of patients with emesis reported no more than two episodes, and 62% of patients with nausea reported intensity as 3 or less on a scale from 0 to 10. There were no unexpected or serious adverse events reported.
  
  
  CONCLUSIONS
  Adding 7 days of aprepitant to a 5HT3 receptor antagonist and dexamethasone effectively controlled acute and delayed emesis with 5-day cisplatin regimens. Days of nausea were more common than days of vomiting.
authors.affiliation: Sydney Medical School, CEO Cancer Council Australia, GPO Box 408, Sydney, New South Wales, 2001, Australia. ian.olver@cancer.org.au
authors.forename: I N
authors.initials: IN
authors.lastname: Olver
authors.forename: P
authors.initials: P
authors.lastname: Grimison
authors.forename: M
authors.initials: M
authors.lastname: Chatfield
authors.forename: M R
authors.initials: MR
authors.lastname: Stockler
authors.forename: G C
authors.initials: GC
authors.lastname: Toner
authors.forename: V
authors.initials: V
authors.lastname: Gebski
authors.forename: R
authors.initials: R
authors.lastname: Harrup
authors.forename: C
authors.initials: C
authors.lastname: Underhill
authors.forename: G
authors.initials: G
authors.lastname: Kichenadasse
authors.forename: N
authors.initials: N
authors.lastname: Singhal
authors.forename: I D
authors.initials: ID
authors.lastname: Davis
authors.forename: A
authors.initials: A
authors.lastname: Boland
authors.forename: A
authors.initials: A
authors.lastname: McDonald
authors.forename: D
authors.initials: D
authors.lastname: Thomson
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000932:Antiemetics / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000009:adverse effects / Q000627:therapeutic use; D000077608:Aprepitant; D002945:Cisplatin / Q000009:adverse effects* / Q000627:therapeutic use; D003907:Dexamethasone / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D008297:Male; D008479:Mediastinal Neoplasms / Q000188:drug therapy / Q000473:pathology; D008875:Middle Aged; D009025:Morpholines / Q000008:administration & dosage*; D009325:Nausea / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*; D009373:Neoplasms, Germ Cell and Embryonal / Q000188:drug therapy* / Q000556:secondary; D010051:Ovarian Neoplasms / Q000188:drug therapy / Q000473:pathology; D012186:Retroperitoneal Neoplasms / Q000188:drug therapy / Q000473:pathology; D058831:Serotonin 5-HT3 Receptor Antagonists / Q000008:administration & dosage; D013736:Testicular Neoplasms / Q000188:drug therapy* / Q000473:pathology; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000188:drug therapy / Q000517:prevention & control*; D055815:Young Adult
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents; D009025:Morpholines; D058831:Serotonin 5-HT3 Receptor Antagonists; D000077608:Aprepitant; D003907:Dexamethasone; D002945:Cisplatin