title: Gemcitabine and vinorelbine as second-line treatment in patients with metastatic breast cancer: a phase II study.
abstract: BACKGROUND
  To evaluate the feasibility and activity of gemcitabine and vinorelbine as a second/third-line approach in patients with advanced breast cancer.
  
  
  METHODS
  Entered into the study were 51 consecutive patients. All had been previously treated with anthracyclines. Of these 51 patients, 36 had experienced failure or relapse after one chemotherapy line for advanced disease, and 15 after two chemotherapy lines. The dominant sites of involvement were brain in 4 patients (7.8%), liver in 22 (43.2%), lung in 10 (19.6%), bone in 10 (19.6), and soft-tissue in 5 (9.8%). Treatment consisted of vinorelbine 25 mg/m(2) and gemcitabine 1000 mg/m(2) administered on days 1 and 8 every 21 days.
  
  
  RESULTS
  The scheme was well tolerated. Grade 3/4 neutropenia was observed in 11% of patients. Grade 3 nausea and vomiting occurred in 6%, and grade 2 neurotoxicity in 6%. No patients experienced grade 3/4 alopecia. The median relative dose intensity was 94.6% (49.7-100%) and 90.0% (23.1-100%) for vinorelbine and gemcitabine, respectively. Two patients (3.9%) were not evaluable for disease response, 4 (7.8%) attained a clinical complete response, 13 (25.5%) a partial response (for an overall response rate of 33.3%, 95% coefficient interval 20.0-46.0%), 23 (45.2%) showed stable disease, and 9 (17.6%) progressed. The median time to progression of responding patients was 10.8 months, and the median overall survival of the entire population was 17.8 months.
  
  
  CONCLUSIONS
  Vinorelbine and gemcitabine is a manageable scheme with moderate activity in pretreated patients with advanced breast cancer.
authors.affiliation: Oncologia Medica, Centro Oncologico Ematologico Subalpino, Azienda Ospedaliera Molinette, Corso Bramante 33, 10126, Turin, Italy. magoab@libero.it
authors.forename: Michela
authors.initials: M
authors.lastname: Donadio
authors.forename: Mara
authors.initials: M
authors.lastname: Ardine
authors.forename: Alfredo
authors.initials: A
authors.lastname: Berruti
authors.forename: Giuliana
authors.initials: G
authors.lastname: Ritorto
authors.forename: Elena
authors.initials: E
authors.lastname: Fea
authors.forename: Marinella
authors.initials: M
authors.lastname: Mistrangelo
authors.forename: Zaira
authors.initials: Z
authors.lastname: Coccorullo
authors.forename: Paola
authors.initials: P
authors.lastname: Bergnolo
authors.forename: Alessandro
authors.initials: A
authors.lastname: Comandone
authors.forename: Oscar
authors.initials: O
authors.lastname: Bertetto
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D018450:Disease Progression; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D009362:Neoplasm Metastasis; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives*; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D014747:Vinblastine; D000077235:Vinorelbine; D000093542:Gemcitabine