title: A phase II trial of oral vinorelbine and capecitabine in anthracycline pretreated patients with metastatic breast cancer.
abstract: BACKGROUND
  Optimal chemotherapy (CT) for advanced breast treatment should be effective, well tolerated and convenient. In this study the efficacy and safety of the fully oral combination of oral vinorelbine (Navelbine Oral) plus capecitabine (Xeloda) in metastatic breast cancer (MBC) patients pretreated with anthracycline, was evaluated.
  
  
  METHODS
  In this phase II multicenter study, this combination CT was given as a first- or second-line therapy for MBC. The treatment schedule was: oral vinorelbine 60 mg/m2 day 1 and day 8 plus capecitabine 1,000 mg/m2 twice daily from day 1 to day 14, every 21 days.
  
  
  RESULTS
  One hundred and fifteen patients were included in this trial. The median age was 58 years (range: 40-75). All the patients had received prior anthracycline-based chemotherapy. The combination was well tolerated, with, in particular, only 0.8% of patients presenting with febrile neutropenia. In the intention-to-treat (ITT) population, an objective response was achieved in 65 patients (56.5%). A complete response was achieved in 22 patients (19.1%); partial response in 43 patients (37.4%); stable disease in 36 patients (31.3%), and progressive disease was observed in 14 patients (12.2%). After a median follow-up of 10.0 months, the median progression-free survival (PFS) was 10.5 months and the median survival was 17.5 months.
  
  
  CONCLUSIONS
  Oral vinorelbine-capecitabine shows very promising activity and low toxicity in MBC treatment, with high compliance of the patients.
authors.affiliation: University Hospital Pilsen, Czech Republic. finek@fnplzen.cz
authors.forename: Jindrich
authors.initials: J
authors.lastname: Finek
authors.forename: Lubos
authors.initials: L
authors.lastname: Holubec
authors.forename: Tomas
authors.initials: T
authors.lastname: Svoboda
authors.forename: Lucie
authors.initials: L
authors.lastname: Sefrhansova
authors.forename: Ivana
authors.initials: I
authors.lastname: Pavlikova
authors.forename: Marie
authors.initials: M
authors.lastname: Votavova
authors.forename: Marcela
authors.initials: M
authors.lastname: Sediva
authors.forename: Stanislav
authors.initials: S
authors.lastname: Filip
authors.forename: Renata
authors.initials: R
authors.lastname: Kozevnikova
authors.forename: Stanislav
authors.initials: S
authors.lastname: Kormunda