title: Biweekly vinorelbine and tegafur/uracil in patients with metastatic breast cancer previously treated with anthracyclines and taxanes: GEICAM 2000-02 phase II study.
abstract: BACKGROUND
  To assess the efficacy and safety profile of biweekly vinorelbine and tegafur/uracil (UFT) as treatment in patients with metastatic breast cancer previously treated with anthracyclines and taxanes.
  
  
  METHODS
  Patients with histologically confirmed breast cancer, measurable disease, no more than one prior chemotherapy regimen for metastatic disease, an Eastern Cooperative Oncology Group (ECOG) performance status ≤2, and adequate bone marrow, renal and liver function were eligible. Patients received vinorelbine (30 mg/m(2) on day 1) and UFT (250 mg/m(2) daily) every two weeks for 12 cycles unless progression or unacceptable toxicity was observed.
  
  
  RESULTS
  Thirty-seven patients were included and received 311 cycles of chemotherapy. Efficacy and toxicity analyses were carried out on an intention-to-treat basis. The overall response rate was 35% (95% CI: 20-53). With a median follow-up of 18.6 months (95% CI: 1.0-74.3), the median time to progression was 7.0 months (96% CI: 5.2-8.9) and the median overall survival was 19.4 months (95% CI: 11.1-27.8). The most common severe toxicities were neutropenia (38% of patients) and asthenia (11% of patients).
  
  
  CONCLUSIONS
  The combination of biweekly vinorelbine and UFT in patients with metastatic breast cancer pretreated with anthracyclines and taxanes is a well tolerated and effective regimen. AEMPS Trial Registration No.: 00-0534.
authors.affiliation: Medical Oncology Service, Hospital Universitario Miguel Servet, Zaragoza, Spain. aantont@gmail.com
authors.forename: Antonio
authors.initials: A
authors.lastname: Antón
authors.forename: Agustí
authors.initials: A
authors.lastname: Barnadas
authors.forename: Jesús
authors.initials: J
authors.lastname: Florián
authors.forename: Nuria
authors.initials: N
authors.lastname: Ribelles
authors.forename: María
authors.initials: M
authors.lastname: Lomas
authors.forename: Juan
authors.initials: J
authors.lastname: Lao
authors.forename: Ana
authors.initials: A
authors.lastname: González-Quintás
authors.forename: Mireia
authors.initials: M
authors.lastname: Margelí
authors.forename: Ana Belén
authors.initials: AB
authors.lastname: Paules
authors.forename: Javier
authors.initials: J
authors.lastname: Gayo
authors.forename: Manuel
authors.initials: M
authors.lastname: Ramos
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018943:Anthracyclines / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D053208:Kaplan-Meier Estimate; D008875:Middle Aged; D016879:Salvage Therapy / Q000379:methods*; D043823:Taxoids / Q000627:therapeutic use; D005641:Tegafur / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014498:Uracil / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives* / Q000627:therapeutic use; D000077235:Vinorelbine
chemical_list: D018943:Anthracyclines; D043823:Taxoids; D005641:Tegafur; D014498:Uracil; D014747:Vinblastine; D000077235:Vinorelbine