title: Results from an observational trial with oral vinorelbine and trastuzumab in advanced breast cancer.
abstract: OBJECTIVE
  We evaluated the efficacy and tolerability of oral vinorelbine plus trastuzumab (OV + T) in Her2 positive advanced breast cancer as first line chemotherapy or after progressing on earlier treatment.
  
  
  METHODS
  Thirty consecutive patients (median age: 59 years) were included. Patients received OV in a dose of 60 mg/m(2) on day 1 and 8, q=21, without dose escalation. Trastuzumab was administered every 3 weeks at a dose of 6 mg/kg bodyweight after a loading dose of 8 mg/kg. Response was evaluated every three cycles using UICC criteria. Time to progression (TTP) and overall survival (OS) were estimated using the Kaplan-Meier product limit method. A multivariate analysis was performed to evaluate factors potentially influencing response rate and TTP.
  
  
  RESULTS
  Median time of observation was 20 months. We observed a complete response in 18% of patients, partial remission in 50%, stable disease >or= 6 months in 21%, and progressive disease in 11%. TTP was median 9 months. OS was not reached. Response rate and TTP were influenced by line of treatment only. The main toxicities consisted of neutropenia and nausea.
  
  
  CONCLUSIONS
  OV + T appears to be an effective and safe treatment option in advanced breast cancer at the dose and schedule chosen.
authors.affiliation: Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, 18-20 Waehringer Guertel, A-1090, Vienna, Austria.
authors.forename: Rupert
authors.initials: R
authors.lastname: Bartsch
authors.forename: Catharina
authors.initials: C
authors.lastname: Wenzel
authors.forename: Gabriela
authors.initials: G
authors.lastname: Altorjai
authors.forename: Ursula
authors.initials: U
authors.lastname: Pluschnig
authors.forename: Thomas
authors.initials: T
authors.lastname: Bachleitner-Hoffmann
authors.forename: Gottfried J
authors.initials: GJ
authors.lastname: Locker
authors.forename: Margaretha
authors.initials: M
authors.lastname: Rudas
authors.forename: Robert
authors.initials: R
authors.lastname: Mader
authors.forename: Christoph C
authors.initials: CC
authors.lastname: Zielinski
authors.forename: Guenther G
authors.initials: GG
authors.lastname: Steger
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D005260:Female; D018734:Genes, erbB-2; D006801:Humans; D007150:Immunohistochemistry; D017404:In Situ Hybridization, Fluorescence; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D016019:Survival Analysis; D000068878:Trastuzumab; D016896:Treatment Outcome; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D014747:Vinblastine; D000068878:Trastuzumab; D000077235:Vinorelbine