title: Phase I study of oral vinorelbine and capecitabine in patients with metastatic breast cancer.
abstract: BACKGROUND
  To determine the recommended doses of oral vinorelbine (VN) and capecitabine (C) in metastatic breast cancer.
  
  
  METHODS
  Eighteen patients with metastatic breast cancer received oral VN (on days 1 and 8) and C (on days 1 to 14) every three weeks at one of four dose levels: I) 60 mg/m(2) and 1650 mg/m(2)/day; II) 70 mg/m(2) and 1650 mg/m(2)/day; III) 70 mg/m(2) and 2000 mg/m(2)/day; IV) 80 mg/m(2) and 2000 mg/m(2)/day, respectively. The primary endpoint was to determine the recommended doses for the combination of oral VN and C in metastatic breast cancer. Secondary endpoints include evaluating response rate, safety profile and whether or not VN dosage escalation was required.
  
  
  RESULTS
  Severe neutropenia occurred in 28% of patients; and severe anaemia and leucopenia were observed in one patient each (6%). One patient developed febrile neutropenia. Non-hematological toxicities were rare. The response rate was 28% (95% CI: 10-54) in the intention-to-treat population.
  
  
  CONCLUSIONS
  The recommended dose is 80 mg/m(2) of oral VN on days 1 and 8, and 2000 mg/m(2)/day of C from days 1 to 14 in three weekly cycles. A phase II study with this schedule is currently under way.
authors.affiliation: Medical Oncology Service, University Hospital Miguel Servet, Avda. Isabel La Católica 1-3, 50009 Zaragoza, Spain. aantont@salud.aragon.es
authors.forename: Antonio
authors.initials: A
authors.lastname: Anton
authors.forename: Ana
authors.initials: A
authors.lastname: Lluch
authors.forename: Antonio
authors.initials: A
authors.lastname: Casado
authors.forename: Mariano
authors.initials: M
authors.lastname: Provencio
authors.forename: Montserrat
authors.initials: M
authors.lastname: Muñoz
authors.forename: Juan
authors.initials: J
authors.lastname: Lao
authors.forename: Begoña
authors.initials: B
authors.lastname: Bermejo
authors.forename: Ana B
authors.initials: AB
authors.lastname: Paules
authors.forename: Javier
authors.initials: J
authors.lastname: Gayo
authors.forename: Miguel
authors.initials: M
authors.lastname: Martin
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D006801:Humans; D008297:Male; D008875:Middle Aged; D009362:Neoplasm Metastasis; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D000077235:Vinorelbine
chemical_list: D003841:Deoxycytidine; D014747:Vinblastine; D000069287:Capecitabine; D000077235:Vinorelbine; D005472:Fluorouracil