title: Phase 2 study of single-agent IV vinflunine as third-line treatment of metastatic breast cancer after failure of anthracycline-/taxane-based chemotherapy.
abstract: OBJECTIVE
  A multicenter, open-label, phase 2 study evaluated the efficacy and safety of intravenous vinflunine as third-line treatment in patients with progressing metastatic breast cancer (MBC) after failure of anthracycline- and taxane-based chemotherapy.
  
  
  METHODS
  Fifty-six patients with MBC, relapsing after receiving 2 previous treatments for advanced disease, including both anthracyclines and taxanes, received 320 mg/m(2) of vinflunine once every 3 weeks (median number of 2.5 cycles, range: 1-13).
  
  
  RESULTS
  According to an independent radiologist, the response rate was 12.5% (95% CI: 5.2-24.1) and 14% (95% CI: 5.3-27.9) (6 partial responses) in the treated and evaluable populations, respectively. Disease control was achieved in 42.9% and 51.2% of the patients, respectively. Median progression-free survival was 2.6 months (95% CI: 1.6-4.0 months) with a median overall survival of 11.4 months (95% CI: 7.4-14.2 months). Duration of response was 6.8 months (95% CI: 5.6 months, upper limit not reached). Leukopenia was the most frequent hematologic toxicity, with grade 3/4 severity in 49.1% of the patients. Grade 3 neutropenia in 30.9%, grade 4 in 40.0% of patients, febrile neutropenia (5.4%), and 1 case of neutropenia infection (1.8%) were reported. Other grade 3 toxicities included anemia (5.5%), fatigue (14.3%), and constipation (7.1%), which were noncumulative. The adverse events associated with vinflunine were predictable and manageable.
  
  
  CONCLUSIONS
  Vinflunine is an active and well-tolerated agent as third-line treatment of patients with MBC after failure of anthracycline- and taxane-based therapy. These results warrant further investigation of vinflunine monotherapy or in combination for the treatment of MBC.
authors.affiliation: Centre Georges-François Leclerc, Dijon, France.
authors.forename: Pierre
authors.initials: P
authors.lastname: Fumoleau
authors.forename: Hernan
authors.initials: H
authors.lastname: Cortés-Funes
authors.forename: Amina B
authors.initials: AB
authors.lastname: Taleb
authors.forename: Stephen
authors.initials: S
authors.lastname: Chan
authors.forename: Mario
authors.initials: M
authors.lastname: Campone
authors.forename: Jean-Christophe
authors.initials: JC
authors.lastname: Pouget
authors.forename: Michèle
authors.initials: M
authors.lastname: Tubiana-Hulin
authors.forename: Conrad F
authors.initials: CF
authors.lastname: Slabber
authors.forename: Isabelle
authors.initials: I
authors.lastname: Caroff-Paraïso
authors.forename: Albert S
authors.initials: AS
authors.lastname: Alberts
authors.forename: Farhat
authors.initials: F
authors.lastname: Ben Ayed
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage*; D000970:Antineoplastic Agents / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects*; D001932:Brain Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000556:secondary; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D001952:Bridged-Ring Compounds / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D043823:Taxoids / Q000008:administration & dosage*; D017211:Treatment Failure; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*
chemical_list: D018943:Anthracyclines; D000970:Antineoplastic Agents; D001952:Bridged-Ring Compounds; D043823:Taxoids; C080625:taxane; C111217:vinflunine; D014747:Vinblastine