title: Phase II trial of capecitabine and vinorelbine as first-line chemotherapy for metastatic breast cancer patients.
abstract: BACKGROUND
  Vinorelbine is one of the most active cytotoxic agents in metastatic breast cancer. Its association with 5-Fluorouracil generates objective responses, varying between 44 and 55%, and improves the tolerance profile. The aim of this multicenter phase II trial was to assess the combination of capecitabine and vinorelbine as first-line chemotherapy in patients with metastatic breast cancer (MBC).
  
  
  METHODS
  Thirty patients with MBC received a 3-week cycle combining capecitabine 825 mg/m2 twice a day on days 1 through 14, with 25 mg/m2 of vinorelbine on days 1 and 8. Treatment continued until progression, unacceptable toxicity or patient refusal to continue. The median age was 54 years (30-77) and the median WHO-PS was 1. Twenty patients (67%) received adjuvant chemotherapy including anthracycline and taxanes.
  
  
  RESULTS
  Objective responses occurred in 21 patients (70%). Stable disease lasting more than 6 months was observed in six patients (20%). The clinical benefit rate was 90%. The median progression-free survival and overall survival were 10 months and 30.4 months, respectively. The most frequent treatment-related toxicities were: WHO grades 3 and 4 neutropenia (two patients), febrile neutropenia (two patients), grade 3 asthenia (two patients) and grade 3 nausea/vomiting (one patient). No grade 3 hand-foot syndrome was observed.
  
  
  CONCLUSIONS
  The combination of capecitabine and vinorelbine is an active and safe regimen for first-line treatment of MBC.
authors.affiliation: Department of Oncology-Hematology, Hôtel-Dieu de France University Hospital, Achrafieh, Blvd Alfred Naccache, P.O. Box: 166830, Beirut, Lebanon, France. drghosn@sodetel.net.lb
authors.forename: Marwan
authors.initials: M
authors.lastname: Ghosn
authors.forename: Joseph
authors.initials: J
authors.lastname: Kattan
authors.forename: Fadi
authors.initials: F
authors.lastname: Farhat
authors.forename: Fariha
authors.initials: F
authors.lastname: Younes
authors.forename: Jamal
authors.initials: J
authors.lastname: Gasmi
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D000069287:Capecitabine; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; 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