title: Phase II study of intravenous vinflunine after failure of first-line vinorelbine based regimen for advanced breast cancer.
abstract: OBJECTIVE
  This open label phase II study evaluated the safety and efficacy of vinflunine in patients with breast cancer previously treated with a vinorelbine-based regimen and who progressed during or within 6 months of completing this chemotherapy.
  
  
  METHODS
  Thirty eight patients received vinflunine 320 mg/m(2) once every 3 weeks. The primary efficacy endpoint was overall response rate (ORR). Secondary endpoints included disease control rate (DCR), progression-free survival (PFS), overall survival (OS) and safety.
  
  
  RESULTS
  ORR was 8.3% (95% CI: 1.75-22.4) and DCR was 75% (95% CI: 57.8-87.9). PFS was 4.0 months (95% CI: 2.5-6.1) and OS was 13.6 months (95% CI: 8.7-18.9). Toxicities not hampering dose intensity were as expected neutropenia (75.6% of patients), fatigue (44.7%), constipation (28.9%) and abdominal pain (26.3%).
  
  
  CONCLUSIONS
  Vinflunine demonstrated antitumour activity and can be safely administered in breast cancer patients refractory/resistant to vinorelbine.
authors.affiliation: Wojewodzki Szpital Specjalistyczny im. M. Kopernika, Ul. Paderewskiego 4, Oddzial Chorób Rozrostowych, 93509 Łodz, Poland. marie.claire.pinel@pierre-fabre.com
authors.forename: Maria
authors.initials: M
authors.lastname: Blasinska-Morawiec
authors.forename: Nicole
authors.initials: N
authors.lastname: Tubiana-Mathieu
authors.forename: Ronan
authors.initials: R
authors.lastname: Fougeray
authors.forename: Marie-Claire
authors.initials: MC
authors.lastname: Pinel
authors.forename: Philippe
authors.initials: P
authors.lastname: Bougnoux
mesh_terms: D000328:Adult; D000368:Aged; D000972:Antineoplastic Agents, Phytogenic / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D018572:Disease-Free Survival; D004334:Drug Administration Schedule; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D011446:Prospective Studies; D015996:Survival Rate; D017211:Treatment Failure; D016896:Treatment Outcome; D014747:Vinblastine / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D000972:Antineoplastic Agents, Phytogenic; C111217:vinflunine; D014747:Vinblastine; D000077235:Vinorelbine