title: Vinorelbine as first-line or second-line therapy for advanced breast cancer: a Phase I-II trial by the Danish Breast Cancer Co-operative Group.
abstract: BACKGROUND
  This study was conducted to establish the maximum tolerated dose (MTD) of intravenous vinorelbine and on the determined dose to assess efficacy and safety in patients with metastatic breast cancer previously treated with epirubicin.
  
  
  METHODS
  Patients had histologically proven breast cancer and had received a prior epirubicin based regimen either adjuvant or as first line therapy for advanced disease. Vinorelbine was administered intravenously day 1 and 8 in a 3 weeks' schedule. Subsequently 48 additional patients were treated at one dose-level below MTD.
  
  
  RESULTS
  Fifty-five patients were included in the dose-escalation study, which defined 40 mg/m(2) as the MTD. Neutropenia of short duration and autonomic neuropathy causing constipation were the most common dose-limiting toxicities. At the 35 mg/m(2) dose-level 60 patients were included in total. Seven (12%; 95% CI 6 to 22) had a partial response and 16 additional patients had stable disease. 27% had stable disease (clinical benefit rate 38%, 95% CI 27 to 51). The median overall survival was 45 weeks and 39% of the patients were alive after one year.
  
  
  CONCLUSIONS
  The clinical benefit rate was 38% with an overall intention to treat response rate of only 12%. The results were, however, achieved with low subjective burdens of toxicity.
authors.affiliation: Department of Oncology, Vejle Sygehus, Vejle, Denmark.
authors.forename: Sven T
authors.initials: ST
authors.lastname: Langkjer
authors.forename: Bent
authors.initials: B
authors.lastname: Ejlertsen
authors.forename: Henning
authors.initials: H
authors.lastname: Mouridsen
authors.forename: Jørn
authors.initials: J
authors.lastname: Andersen
authors.forename: Mette Møller
authors.initials: MM
authors.lastname: Nielsen
authors.forename: Knud Age
authors.initials: KA
authors.lastname: Møller
authors.forename: Ebbe Lindegaard
authors.initials: EL
authors.lastname: Madsen
authors.forename: Vera
authors.initials: V
authors.lastname: Haarh
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects* / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D014747:Vinblastine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; D014747:Vinblastine; D000077235:Vinorelbine