title: Control of nausea with palonosetron versus granisetron, both combined with dexamethasone, in patients receiving cisplatin- or anthracycline plus cyclophosphamide-based regimens.
abstract: In a comparative phase 3 study involving 1114 Japanese patients receiving highly emetogenic chemotherapy (HEC), palonosetron (PALO) was found to be superior to granisetron (GRA) for the prophylaxis of chemotherapy-induced nausea and vomiting (CINV) in the delayed phase. This post hoc analysis of the phase 3 study evaluated the efficacy of PALO for the control of nausea.
  
  
  
  The proportion of patients without nausea was assessed at 24-h intervals during the acute phase (0-24 h), delayed phase (24-120 h), and overall (0-120 h). No nausea rates were also evaluated by sex, type of chemotherapy (cisplatin or doxorubicin/epirubicin plus cyclophosphamide [AC/EC]), and age (<55 vs. ≥55 years). Nausea severity was categorized using a 4-point Likert scale (0 = no nausea to 3 = severe nausea).
  
  
  
  The proportion of patients without nausea was significantly higher in the PALO arm than in the GRA arm in the delayed phase (37.8 % vs. 27.2 %; p = 0.002) and overall (31.9 % vs. 25.0 %; p = 0.0117). When analyzed by stratification factors, the proportion of patients without nausea was significantly higher in the PALO arm in the delayed phase and overall in patients who were female, younger, or treated with cisplatin and in the delayed phase in patients who were older or treated with doxorubicin or epirubicin plus cyclophosphamide (all p < 0.05).
  
  
  
  PALO was more effective than GRA in prophylaxis of HEC-induced nausea in the delayed phase and overall. In addition, PALO was more effective than GRA in young and female patients, who are at high risk of CINV, both in the delayed phase and overall.
authors.affiliation: Department of Pulmonary Medicine and Oncology, Graduate School of Medicine, Nippon Medical School, 1-1-5 Sendagi, Bunkyo-ku, Tokyo, 113-8603, Japan. kkubota@nms.ac.jp.
authors.forename: Kaoru
authors.initials: K
authors.lastname: Kubota
authors.affiliation: Department of Breast Oncology, Juntendo University Hospital, Tokyo, Japan.
authors.forename: Mitsue
authors.initials: M
authors.lastname: Saito
authors.affiliation: Department of Breast Oncology, National Hospital Organization Shikoku Cancer Center, Ehime, Japan.
authors.forename: Kenjiro
authors.initials: K
authors.lastname: Aogi
authors.affiliation: Division of Internal Medicine and Thoracic Oncology, National Cancer Centre Hospital, Tokyo, Japan.
authors.forename: Ikuo
authors.initials: I
authors.lastname: Sekine
authors.affiliation: Bioscience Medical Research Centre, Niigata University Medical and Dental Hospital, Niigata, Japan.
authors.forename: Hirohisa
authors.initials: H
authors.lastname: Yoshizawa
authors.affiliation: Department of Breast Oncology, Gunma Cancer Centre, Gunma, Japan.
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Yanagita
authors.affiliation: Department of Thoracic Oncology, Saitama Cancer Centre, Saitama, Japan.
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Sakai
authors.affiliation: Department of Breast Oncology, Saitama Cancer Centre, Saitama, Japan.
authors.forename: Kenichi
authors.initials: K
authors.lastname: Inoue
authors.affiliation: Department of Respiratory Medicine, National Hospital Organization Nagoya Medical Centre, Aichi, Japan.
authors.forename: Chiyoe
authors.initials: C
authors.lastname: Kitagawa
authors.affiliation: Division of Respiratory Medicine, Kanagawa Cardiovascular and Respiratory Centre, Kanagawa, Japan.
authors.forename: Takashi
authors.initials: T
authors.lastname: Ogura
mesh_terms: D018943:Anthracyclines / Q000008:administration & dosage / Q000009:adverse effects; D000932:Antiemetics / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects*; D002945:Cisplatin / Q000008:administration & dosage / Q000009:adverse effects; D003520:Cyclophosphamide / Q000008:administration & dosage / Q000009:adverse effects; D003907:Dexamethasone / Q000627:therapeutic use*; D005260:Female; D017829:Granisetron / Q000627:therapeutic use*; D006801:Humans; D007546:Isoquinolines / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced* / Q000188:drug therapy*; D000077924:Palonosetron; D011812:Quinuclidines / Q000627:therapeutic use*; D014839:Vomiting / Q000139:chemically induced* / Q000188:drug therapy*
chemical_list: D018943:Anthracyclines; D000932:Antiemetics; D002945:Cisplatin; D003520:Cyclophosphamide; D003907:Dexamethasone; D017829:Granisetron; D007546:Isoquinolines; D000077924:Palonosetron; D011812:Quinuclidines
keywords: 5-HT3 receptor antagonist; Antiemetics; Chemotherapy-induced nausea and vomiting; Highly emetic chemotherapy; Palonosetron