title: The safety of concentrated trastuzumab in 100 ml of saline solution for administration to patients with HER2-positive breast cancer: a phase 1 study.
abstract: BACKGROUND
  It is recommended that administration of trastuzumab should be carried out in a volume of 250 ml of saline solution over 90 min. Since 2011, recommendations have allowed a shortening of the administration time to 30 min at the second administration. However, the volume to be administered is still 250 ml. The purpose of this study was to evaluate the safety of trastuzumab administered in 100 ml of saline solution over 30 min.
  
  
  METHODS
  This study enrolled patients with HER2-positive breast cancer. Three dose levels of trastuzumab, each in 100 ml of saline solution, were used (2, 6 and 8 mg/kg). The primary end point was the determination of safety.
  
  
  RESULTS
  Nine patients were enrolled. Since no adverse events were observed, the 8 mg/kg/100 ml saline solution dose level was the recommended dose.
  
  
  CONCLUSIONS
  A 30-min administration of trastuzumab in 100 ml of saline solution is safe in patients with HER2-positive breast cancer.
authors.affiliation: Department of Surgery, Kitasato University School of Medicine, Sagamihara, Japan.
authors.forename: Norihiko
authors.initials: N
authors.lastname: Sengoku
authors.forename: Hirokazu
authors.initials: H
authors.lastname: Tanino
authors.forename: Yoshimasa
authors.initials: Y
authors.lastname: Kosaka
authors.forename: Mariko
authors.initials: M
authors.lastname: Kikuchi
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Nishimiya
authors.forename: Mina
authors.initials: M
authors.lastname: Waraya
authors.forename: Hiroshi
authors.initials: H
authors.lastname: Katoh
authors.forename: Takumo
authors.initials: T
authors.lastname: Enomoto
authors.forename: Takeo
authors.initials: T
authors.lastname: Sato
authors.forename: Masaru
authors.initials: M
authors.lastname: Kuranami
authors.forename: Masahiko
authors.initials: M
authors.lastname: Watanabe
mesh_terms: D000328:Adult; D000368:Aged; D061067:Antibodies, Monoclonal, Humanized / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000473:pathology; D054796:Drug Dosage Calculations; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism*; D012965:Sodium Chloride / Q000737:chemistry*; D000068878:Trastuzumab; D016896:Treatment Outcome; D016277:Ventricular Function, Left
chemical_list: D061067:Antibodies, Monoclonal, Humanized; D018719:Erb-b2 Receptor Tyrosine Kinases; D012965:Sodium Chloride; D000068878:Trastuzumab