title: Oral vinorelbine alone or in combination with trastuzumab in advanced breast cancer: results from a pilot trial.
abstract: BACKGROUND
  We evaluated the efficacy of oral vinorelbine (OV) (Navelbine oral Boeringer-Ingelheim Austria) in patients with advanced breast cancer as first-line therapy or after progressing under earlier line chemotherapies alone or in combination with trastuzumab (T).
  
  
  METHODS
  Seventy-eight patients [median age: 63.5 years (y), range (r): 38-84 years] were included into this trial. Patients with her-2/neu positive tumours received a combination of OV and T. Treatment effect was evaluated every three cycles and treatment continued until progression. OV was administered in a dose of 60 mg/m(2) on day 1 and 8, q = 21 days, and no dose escalation to 80 mg/m(2) was performed.
  
  
  RESULTS
  We observed a complete response in 5.9% of patients, partial remission in 22.1%, stable disease (SD) > 6 months in 33.8%, SD < 6 months in 2.9%, and progression despite treatment in 35.3%, respectively. Time to progression was 6 months (range 1-23+). The main toxicities consisted of nausea/vomiting (N/V) and neutropenia. Grade IV neutropenia was found in 5 patients (6.4%), grade III in 6 patients (7.7%) and grade I and II in 11.5%. We did not find any grade IV N/V in our patients, however, grade III N/V was observed in 3.8%. No other grade III and IV toxicities were reported.
  
  
  CONCLUSIONS
  OV appears to be effective in the treatment of advanced breast cancer at the dose and schedule chosen. It is well tolerated, effective, and the oral formulation is an advantage for the patients as well as for the nursing staff.
authors.affiliation: Department of Internal Medicine I, Division of Oncology, Medical University of Vienna, 18-20 Waehringer Guertel, Vienna, Austria. guenther.steger@meduniwien.ac.at
authors.forename: Rupert
authors.initials: R
authors.lastname: Bartsch
authors.forename: Catharina
authors.initials: C
authors.lastname: Wenzel
authors.forename: Ursula
authors.initials: U
authors.lastname: Pluschnig
authors.forename: Dagmar
authors.initials: D
authors.lastname: Hussian
authors.forename: Ursula
authors.initials: U
authors.lastname: Sevelda
authors.forename: Gottfried J
authors.initials: GJ
authors.lastname: Locker
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 / Q000009:adverse effects / Q000627:therapeutic use*; D001859:Bone Neoplasms / Q000188:drug therapy / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008113:Liver Neoplasms / Q000188:drug therapy / Q000556:secondary; D008175:Lung Neoplasms / Q000188:drug therapy / Q000556:secondary; D008875:Middle Aged; D010865:Pilot Projects; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D012878:Skin Neoplasms / Q000188:drug therapy / Q000556:secondary; D015996:Survival Rate; D000068878:Trastuzumab; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D018719:Erb-b2 Receptor Tyrosine Kinases; D000068878:Trastuzumab; D014747:Vinblastine; D000077235:Vinorelbine