title: A multicenter randomized phase III trial of vinorelbine/gemcitabine doublet versus capecitabine monotherapy in anthracycline- and taxane-pretreated women with metastatic breast cancer.
abstract: BACKGROUND
  The Breast Cancer Study Group of the Hellenic Oncology Research Group conducted a phase III trial of single-agent capecitabine versus the vinorelbine/gemcitabine doublet in patients with metastatic breast cancer (MBC) pretreated with anthracyclines and taxanes. The primary objective was to demonstrate superiority of combination treatment in terms of progression-free survival (PFS).
  
  
  METHODS
  Women with MBC were randomly assigned to receive either capecitabine (Cap arm: 1250 mg/m(2) twice daily, on days 1-14) or vinorelbine/gemcitabine doublet (VG arm: vinorelbine 25 mg/m(2); gemcitabine 1000 mg/m(2); both drugs on days 1 and 15).
  
  
  RESULTS
  Seventy-four women were treated on each arm and median PFS was 5.4 versus 5.2 months (P = 0.736), for VG and Cap, respectively. Median overall survival was 20.4 months for the VG arm and 22.4 months for the Cap arm (P = 0.319). Overall response rate was 28.4% in the VG arm and 24.3% in the Cap arm (P = 0.576). Both regimens were generally well tolerated. Neutropenia and fatigue were more common with VG arm and hand-foot syndrome with Cap arm.
  
  
  CONCLUSIONS
  This trial failed to demonstrate superiority of vinorelbine/gemcitabine doublet over single-agent capecitabine in terms of PFS. Given the favorable toxicity and convenience of oral administration, single-agent capecitabine is recommended for compliant patients.
authors.affiliation: Breast Cancer Study Group, Hellenic Oncology Research Group (HORG), Athens, Greece.
authors.forename: A G
authors.initials: AG
authors.lastname: Pallis
authors.affiliation: Breast Cancer Study Group, Hellenic Oncology Research Group (HORG), Athens, Greece.
authors.forename: I
authors.initials: I
authors.lastname: Boukovinas
authors.affiliation: Breast Cancer Study Group, Hellenic Oncology Research Group (HORG), Athens, Greece.
authors.forename: A
authors.initials: A
authors.lastname: Ardavanis
authors.affiliation: Breast Cancer Study Group, Hellenic Oncology Research Group (HORG), Athens, Greece.
authors.forename: I
authors.initials: I
authors.lastname: Varthalitis
authors.affiliation: Breast Cancer Study Group, Hellenic Oncology Research Group (HORG), Athens, Greece.
authors.forename: N
authors.initials: N
authors.lastname: Malamos
authors.affiliation: Breast Cancer Study Group, Hellenic Oncology Research Group (HORG), Athens, Greece.
authors.forename: V
authors.initials: V
authors.lastname: Georgoulias
authors.affiliation: Breast Cancer Study Group, Hellenic Oncology Research Group (HORG), Athens, Greece. Electronic address: mavrudis@med.uoc.gr.
authors.forename: D
authors.initials: D
authors.lastname: Mavroudis
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018943:Anthracyclines / Q000008:administration & dosage / Q000627:therapeutic use; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D000069287:Capecitabine; D002277:Carcinoma / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D019008:Drug Resistance, Neoplasm / Q000187:drug effects / Q000502:physiology; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016879:Salvage Therapy; D043823:Taxoids / Q000008:administration & dosage / Q000627:therapeutic use; D014747:Vinblastine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D018943:Anthracyclines; D043823:Taxoids; D003841:Deoxycytidine; D014747:Vinblastine; D000069287:Capecitabine; D000077235:Vinorelbine; D005472:Fluorouracil; D000093542:Gemcitabine