title: A phase II trial of prophylactic olanzapine combined with palonosetron and dexamethasone for preventing nausea and vomiting induced by cisplatin.
abstract: OBJECTIVE
  To investigate the efficacy and safety of olanzapine in combination with palonosetron and dexamethasone for patients receiving cisplatin (≥50 mg/m(2) ), because this antiemetic therapy has not been sufficiently examined in patients receiving cisplatin.
  
  
  METHODS
  We conducted a phase II study to evaluate the efficacy and safety of olanzapine in combination with palonosetron and dexamethasone for chemotherapy naïve patients receiving cisplatin (≥50 mg/m(2) ). Patients received prophylactic dexamethasone (20 mg IV, day 1), palonosetron (0.75 mg IV, day 1), and olanzapine (10 mg, days 1-4). The patients were monitored for emesis and nausea for 120 h after chemotherapy. The primary endpoint was the complete response (CR) rate, which was defined as no vomiting episodes and no use of rescue medication for the overall period. CR rates of 65% and 45% would indicate the potential usefulness and the lower limit of interest, respectively.
  
  
  RESULTS
  Fifty-one patients, including 37 esophageal cancer patients were enrolled, of whom 41 (80%) completed the treatment protocol as planned. The complete response rate for the overall period was 43% (95% confidence interval: 29-58); the primary endpoint was not met. Vomiting was frequently observed, with the overall rate of 51%. Most events occurred during 24-72 h after chemotherapy. Somnolence was observed in 73% of the patients, but it was well tolerated in most cases.
  
  
  CONCLUSIONS
  Olanzapine combined with palonosetron and dexamethasone did not prevent chemotherapy-induced nausea and vomiting induced by cisplatin as expected. The safety of this antiemetic therapy was confirmed.
authors.affiliation: Department of Pharmacy, Aichi Cancer Center Research Institute, Chikusa-ku, Nagoya, Aichi, Japan.
authors.forename: Akimitsu
authors.initials: A
authors.lastname: Maeda
authors.affiliation: Department of Clinical Oncology, Aichi Cancer Center Research Institute, Chikusa-ku, Nagoya, Aichi, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Ura
authors.affiliation: Department of Pharmacy, Aichi Cancer Center Research Institute, Chikusa-ku, Nagoya, Aichi, Japan.
authors.forename: Chisa
authors.initials: C
authors.lastname: Asano
authors.affiliation: Department of Pharmacy, Aichi Cancer Center Research Institute, Chikusa-ku, Nagoya, Aichi, Japan.
authors.forename: Ikue
authors.initials: I
authors.lastname: Haegawa
authors.affiliation: Department of Clinical Oncology, Aichi Cancer Center Research Institute, Chikusa-ku, Nagoya, Aichi, Japan.
authors.forename: Motoo
authors.initials: M
authors.lastname: Nomura
authors.affiliation: Department of Clinical Oncology, Aichi Cancer Center Research Institute, Chikusa-ku, Nagoya, Aichi, Japan.
authors.forename: Azusa
authors.initials: A
authors.lastname: Komori
authors.affiliation: Department of Clinical Oncology, Aichi Cancer Center Research Institute, Chikusa-ku, Nagoya, Aichi, Japan.
authors.forename: Yukiya
authors.initials: Y
authors.lastname: Narita
authors.affiliation: Department of Clinical Oncology, Aichi Cancer Center Research Institute, Chikusa-ku, Nagoya, Aichi, Japan.
authors.forename: Hiroya
authors.initials: H
authors.lastname: Taniguchi
authors.affiliation: Department of Clinical Oncology, Aichi Cancer Center Research Institute, Chikusa-ku, Nagoya, Aichi, Japan.
authors.forename: Shigenori
authors.initials: S
authors.lastname: Kadowaki
authors.affiliation: Department of Clinical Oncology, Aichi Cancer Center Research Institute, Chikusa-ku, Nagoya, Aichi, Japan.
authors.forename: Kei
authors.initials: K
authors.lastname: Muro
authors.affiliation: Department of Thoracic Oncology, Aichi Cancer Center Research Institute, Chikusa-ku, Nagoya, Aichi, Japan.
authors.forename: Yoshitsugu
authors.initials: Y
authors.lastname: Horio
authors.affiliation: Department of Thoracic Oncology, Aichi Cancer Center Research Institute, Chikusa-ku, Nagoya, Aichi, Japan.
authors.forename: Tatsuya
authors.initials: T
authors.lastname: Yoshida
authors.affiliation: Division of Epidemiology and Prevention, Aichi Cancer Center Research Institute, Chikusa-ku, Nagoya, Aichi, Japan.
authors.forename: Isao
authors.initials: I
authors.lastname: Oze
authors.affiliation: Department of Pharmacy, Aichi Cancer Center Research Institute, Chikusa-ku, Nagoya, Aichi, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Kajita
authors.affiliation: Department of Pharmacy, Aichi Cancer Center Research Institute, Chikusa-ku, Nagoya, Aichi, Japan.
authors.forename: Akiyoshi
authors.initials: A
authors.lastname: Mizutani
mesh_terms: D000328:Adult; D000368:Aged; D000932:Antiemetics / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000009:adverse effects*; D001569:Benzodiazepines / Q000008:administration & dosage* / Q000009:adverse effects; D002945:Cisplatin / Q000009:adverse effects*; D003907:Dexamethasone / Q000008:administration & dosage* / Q000009:adverse effects; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000008:administration & dosage* / Q000009:adverse effects; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D000077152:Olanzapine; D000077924:Palonosetron; D011812:Quinuclidines / Q000008:administration & dosage* / Q000009:adverse effects; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D000970:Antineoplastic Agents; D007546:Isoquinolines; D011812:Quinuclidines; D001569:Benzodiazepines; D000077924:Palonosetron; D003907:Dexamethasone; D000077152:Olanzapine; D002945:Cisplatin
keywords: cisplatin and vomiting; olanzapine