title: Palonosetron in combination with 1-day versus 3-day dexamethasone for prevention of nausea and vomiting following paclitaxel and carboplatin in patients with gynecologic cancers: A randomized, multicenter, phase-II trial.
abstract: OBJECTIVE
  Chemotherapy-induced nausea and vomiting (CINV) can affect a patient's quality of life, leading to poor compliance with further treatments. Previous studies have provided minimal data about carboplatin-based regimens. Female sex is a known risk factor for CINV. The purpose of this study was to evaluate palonosetron plus single-dose dexamethasone (DEX) for preventing CINV caused by carboplatin plus paclitaxel combination therapy (TC regimen) in patients with gynecologic cancers.
  
  
  METHODS
  Patients were recruited for this phase-II, multicenter, randomized trial from 12 hospitals in Hokkaido, Japan. Eligible patients were women with uterine cervical, endometrial or ovarian cancer scheduled to receive conventional TC regimen or dose-dense TC regimen; 116 patients were randomly assigned to receive palonosetron in combination with 1-day DEX or 3-day DEX.
  
  
  RESULTS
  During the overall period, complete response (CR) was observed in 67.9% (95% confidence interval, 53.7-80.1) of patients in the 3-day DEX arm, and 60.7% (95% confidence interval, 46.8-73.5) of patients in the 1-day DEX arm; CR was significantly lower in the 1-day DEX arm if motion sickness was already present (P = 0.0370). In the severe hyperemesis gravidarum cohort, CR in the 1-day DEX arm tended to be lower than in the 3-day DEX arm.
  
  
  CONCLUSIONS
  Combination therapy of palonosetron and 1-day DEX was effective for subjects undergoing a TC regimen for gynecologic cancers. However, the possibility of reduced efficacy of 1-day only DEX therapy in women undergoing a TC regimen could not be refuted and requires further investigation.
authors.affiliation: Department of Gynecology and Obstetrics, Sapporo Medical University, Sapporo, Japan.|Department of Gynecology and Obstetrics, Nikko Memorial Hospital, Muroran, Japan.
authors.forename: Motoki
authors.initials: M
authors.lastname: Matsuura
authors.affiliation: Department of Gynecology and Obstetrics, Sapporo Medical University, Sapporo, Japan.
authors.forename: Seiro
authors.initials: S
authors.lastname: Satohisa
authors.affiliation: Department of Gynecology and Obstetrics, Sapporo Medical University, Sapporo, Japan.
authors.forename: Mizue
authors.initials: M
authors.lastname: Teramoto
authors.affiliation: Department of Gynecology and Obstetrics, Sapporo Medical University, Sapporo, Japan.
authors.forename: Ryoichi
authors.initials: R
authors.lastname: Tanaka
authors.affiliation: Department of Gynecology and Obstetrics, Sapporo Medical University, Sapporo, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Iwasaki
authors.affiliation: Department of Gynecology and Obstetrics, NTT Sapporo Hospital, Sapporo, Japan.
authors.forename: Akira
authors.initials: A
authors.lastname: Nishikawa
authors.affiliation: Department of Gynecology and Obstetrics, Kitami Red Cross Hospital, Kitami, Japan.
authors.forename: Masahiro
authors.initials: M
authors.lastname: Mizunuma
authors.affiliation: Department of Gynecology and Obstetrics, Hakodate Goryokaku Hospital, Hakodate, Japan.
authors.forename: Satoshi
authors.initials: S
authors.lastname: Tanaka
authors.affiliation: Department of Gynecology and Obstetrics, Esashi Hospital, Esashi, Japan.
authors.forename: Osamu
authors.initials: O
authors.lastname: Hayakawa
authors.affiliation: Department of Gynecology and Obstetrics, Sapporo Medical University, Sapporo, Japan.
authors.forename: Tsuyoshi
authors.initials: T
authors.lastname: Saito
mesh_terms: D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000009:adverse effects; D016190:Carboplatin / Q000009:adverse effects; D003907:Dexamethasone / Q000008:administration & dosage*; D005260:Female; D005833:Genital Neoplasms, Female / Q000188:drug therapy; D006801:Humans; D007546:Isoquinolines / Q000627:therapeutic use*; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D017239:Paclitaxel / Q000009:adverse effects; D000077924:Palonosetron; D011812:Quinuclidines / Q000627:therapeutic use*; D012702:Serotonin Antagonists / Q000627:therapeutic use*; D016896:Treatment Outcome; 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; D016190:Carboplatin; D017239:Paclitaxel
keywords: carboplatin; dexamethasone; gynecologic cancers; paclitaxel; palonosetron