title: Randomised phase II trial of gemcitabine plus vinorelbine vs gemcitabine plus cisplatin vs gemcitabine plus capecitabine in patients with pretreated metastatic breast cancer.
abstract: BACKGROUND
  An increasing proportion of patients are exposed to anthracyclines and/or taxanes in the adjuvant or neoadjuvant setting. Re-exposure in the metastatic stage is limited by drug resistance, thus evaluation of non-cross-resistant regimens is mandatory.
  
  
  METHODS
  Anthracycline-pretreated patients were randomly assigned to three gemcitabine-based regimens. Chemotherapy consisted of gemcitabine 1.000 mg m(-2) plus vinorelbin 25 mg m(-2) on days 1+8 (GemVin), or plus cisplatin 30 mg m(-2) on days 1+8 (GemCis), or plus capecitabine 650 mg m(-2) b.i.d. orally days 1-14 (GemCap), q3w. The primary end point was response rate.
  
  
  RESULTS
  A total of 141 patients were recruited on the trial. The overall response rates were 39.0% (GemVin), 47.7% (GemCis) and 34.7% (GemCap). Median progression-free survival was estimated with 5.7, 6.9 and 8.3 months, respectively. Corresponding median survival times were 17.5 (GemVin), 13.0 (GemCis) and 19.4 months (GemCap). Neutropenia ≥grade 3 occurred in 16.7% (Gem/Vin), 4.4% (GemCis) and 0% (Gem/Cap), whereas non-haematological toxicities were rarely severe except grade 3 hand-foot syndrome in 2.0% of the GemCap patients (per patient analysis).
  
  
  CONCLUSIONS
  This randomised phase II trial has revealed comparable results for three gemcitabine-based regimens regarding treatment efficacy and toxicity. Gemcitabine-based chemotherapy appears to be a worthwhile treatment option for pretreated patients with metastatic breast cancer.
authors.affiliation: Med. Department III, Ludwig-Maximilians University of Munich, Campus Grosshadern, Munich, Germany. Joachim.Stemmler@med.uni-muenchen.de
authors.forename: H J
authors.initials: HJ
authors.lastname: Stemmler
authors.forename: D
authors.initials: D
authors.lastname: diGioia
authors.forename: W
authors.initials: W
authors.lastname: Freier
authors.forename: H W
authors.initials: HW
authors.lastname: Tessen
authors.forename: G
authors.initials: G
authors.lastname: Gitsch
authors.forename: W
authors.initials: W
authors.lastname: Jonat
authors.forename: W
authors.initials: W
authors.lastname: Brugger
authors.forename: E
authors.initials: E
authors.lastname: Kettner
authors.forename: W
authors.initials: W
authors.lastname: Abenhardt
authors.forename: H
authors.initials: H
authors.lastname: Tesch
authors.forename: H J
authors.initials: HJ
authors.lastname: Hurtz
authors.forename: S
authors.initials: S
authors.lastname: Rösel
authors.forename: O
authors.initials: O
authors.lastname: Brudler
authors.forename: V
authors.initials: V
authors.lastname: Heinemann
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology; D000069287:Capecitabine; D002945:Cisplatin / Q000008:administration & dosage; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000031:analogs & derivatives; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D014747:Vinblastine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077235:Vinorelbine; D000093542:Gemcitabine
chemical_list: D003841:Deoxycytidine; D014747:Vinblastine; D000069287:Capecitabine; D002945:Cisplatin; D000077235:Vinorelbine; D005472:Fluorouracil; D000093542:Gemcitabine