title: Optimizing clinical care of patients with metastatic breast cancer: a new oral vinorelbine plus trastuzumab combination.
abstract: BACKGROUND
  Trastuzumab (T) combined with i.v. vinorelbine (i.v.VNR) is an active regimen for patients with advanced breast cancer (ABC). In order to further improve quality of life of patients undergoing treatment for ABC, a new regimen using oral vinorelbine (oVNR) (d1 + d3) plus q3wks T was tested (ToVNR).
  
  
  METHODS
  Thirty-nine patients with ABC, human epidermal growth factor receptor 2/neu 3+ or FISH positive received 288 treatment cycles with T 6 mg/kg (loading dose, 8 mg/kg) on d1 and oVNR 55 mg/m(2) on d1 + d3, q3wks until disease progression or unacceptable toxicity.
  
  
  RESULTS
  Thirty-seven patients and 286 treatment cycles were evaluated (two patients were lost to follow-up). Treatment was very well tolerated. Two patients had complete response (CR), 14 partial response (PR), 17 stable disease (SD) and four disease progression (PD) (overall response rate: 43%). Clinical benefit rate (CR + PR + SD >24 months) was 73%. Median time to progression was 8.9 months (range 2-27) and median duration of response was 10.9 months (range 2-27).
  
  
  CONCLUSIONS
  The ToVNR combination is active and very well tolerated. It favorably compares with the combination of T and weekly i.v. administered VNR, allowing a more convenient once every three weeks hospital admission and leaving patients and care providers free from the unpleasant effect of i.v.VNR.
authors.affiliation: Division of Medical Oncology, Unit for Medical Care, Department of Medicine, European Institute of Oncology, Milan, Italy. chiara.catania@ieo.it
authors.forename: C
authors.initials: C
authors.lastname: Catania
authors.forename: M
authors.initials: M
authors.lastname: Medici
authors.forename: E
authors.initials: E
authors.lastname: Magni
authors.forename: E
authors.initials: E
authors.lastname: Munzone
authors.forename: D
authors.initials: D
authors.lastname: Cardinale
authors.forename: L
authors.initials: L
authors.lastname: Adamoli
authors.forename: G
authors.initials: G
authors.lastname: Sanna
authors.forename: I
authors.initials: I
authors.lastname: Minchella
authors.forename: D
authors.initials: D
authors.lastname: Radice
authors.forename: A
authors.initials: A
authors.lastname: Goldhirsch
authors.forename: F
authors.initials: F
authors.lastname: Nolè
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000911:Antibodies, Monoclonal / Q000008:administration & dosage; D061067:Antibodies, Monoclonal, Humanized; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D000068878:Trastuzumab; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; D014747:Vinblastine; D000068878:Trastuzumab; D000077235:Vinorelbine