title: A phase III open-label study to assess safety and efficacy of palonosetron for preventing chemotherapy-induced nausea and vomiting (CINV) in repeated cycles of emetogenic chemotherapy.
abstract: OBJECTIVE
  Prevention of chemotherapy-induced nausea and vomiting (CINV) is of great importance for the completion of multiple cycles of cancer chemotherapy. Palonosetron is a second-generation 5-HT(3) receptor antagonist with proven efficacy for both acute and delayed CINV. This study was designed to assess the safety and efficacy of 0.75 mg palonosetron in repeated cycles of highly emetogenic chemotherapy or anthracycline-cyclophosphamide combination (AC/EC).
  
  
  METHODS
  We gave 0.75 mg palonosetron to 538 patients 30 min prior to ≥ 50 mg/m(2) cisplatin or AC/EC on day 1. Prophylactic dexamethasone was administered on days 1-3. The primary endpoint was the incidence rate of adverse events (AEs). The secondary endpoint was complete response rate (CR, defined as no emesis and no rescue medication) throughout the study period.
  
  
  RESULTS
  Treatment-related AEs were seen in 44% (237 of 538 patients). Serious AEs were seen in 4% (23 of 538 patients), all considered unrelated or unlikely to be related to palonosetron. Only one patient discontinued the study due to a treatment-related AE. No trend toward worsening of AEs was observed in subsequent cycles of chemotherapy. Complete response rates were maintained throughout repeated cycles.
  
  
  CONCLUSIONS
  The extraordinary safety profile and maintenance of efficacy of 0.75 mg palonosetron combined with dexamethasone were demonstrated throughout repeated chemotherapy cycles.
authors.affiliation: Department of Breast Oncology, National Hospital Organization Shikoku Cancer Center, 160 Ko, Minami-Umemoto, Matsuyama, Ehime 791-0280, Japan. kaogi@shikoku-cc.go.jp
authors.forename: Kenjiro
authors.initials: K
authors.lastname: Aogi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Sakai
authors.forename: Hirohisa
authors.initials: H
authors.lastname: Yoshizawa
authors.forename: Norikazu
authors.initials: N
authors.lastname: Masuda
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Katakami
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Yanagita
authors.forename: Kenichi
authors.initials: K
authors.lastname: Inoue
authors.forename: Masaru
authors.initials: M
authors.lastname: Kuranami
authors.forename: Mitsuhiro
authors.initials: M
authors.lastname: Mizutani
authors.forename: Noriyuki
authors.initials: N
authors.lastname: Masuda
mesh_terms: D000368:Aged; D000932:Antiemetics / Q000009:adverse effects / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use; D003907:Dexamethasone / Q000009:adverse effects / Q000627:therapeutic use; D004359:Drug Therapy, Combination; D005260:Female; D006801:Humans; D007546:Isoquinolines / Q000009:adverse effects / Q000627:therapeutic use*; D008297:Male; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced / Q000517:prevention & control*; D009369:Neoplasms / Q000188:drug therapy; D000077924:Palonosetron; D011812:Quinuclidines / Q000009:adverse effects / Q000627:therapeutic use*; D058831:Serotonin 5-HT3 Receptor Antagonists / Q000009:adverse effects / Q000627:therapeutic use; D016896:Treatment Outcome; D014839:Vomiting / Q000139:chemically induced / Q000517:prevention & control*
chemical_list: D000932:Antiemetics; D007546:Isoquinolines; D011812:Quinuclidines; D058831:Serotonin 5-HT3 Receptor Antagonists; D000077924:Palonosetron; D003907:Dexamethasone