title: A multicenter phase II trial of docetaxel plus gemcitabine as salvage treatment in anthracycline- and taxane-pretreated patients with metastatic breast cancer.
abstract: OBJECTIVE
  To evaluate the docetaxel-gemcitabine (DG) combination administered every 2 weeks as salvage therapy in anthracycline- and taxane-pretreated patients with metastatic breast cancer (MBC).
  
  
  METHODS
  Thirty women with MBC who had disease progression after chemotherapy with anthracyclines, or anthracyclines and taxanes were treated with docetaxel 50 mg/m² and gemcitabine 1,500 mg/m² on days 1 and 14 in cycles of 28 days. All patients had received prior anthracyclines, and fourteen (46.6%) had also received prior taxanes. All patients were evaluable for toxicity and 24 for response to treatment.
  
  
  RESULTS
  Complete response occurred in four (13.3%) patients and partial response in 10 (33.3%) for an overall response rate of 46.7% (95% CI 28.8-64.5). Seven patients (23.3%) had stable disease and nine (30%) progressive disease. Of the 14 patients previously treated with both anthracyclines and taxanes, seven (50%) responded. The median duration of response was 4.8 months (range 1.9-15.3), the median time to disease progression 6.6 months (range 0.5-16.9) and the median overall survival 16.8 months (range 1.3-53.2). There was no treatment-related toxic death. Neutropenia was the only grade 4 toxicity occurring in three (10%) patients. None of them developed neutropenic fever. Grade 3 thrombocytopenia occurred in two (6.7%) patients. Non-hematological toxicities were manageable.
  
  
  CONCLUSIONS
  The DG combination administered biweekly is very well tolerated and effective in anthracycline- and taxane-pretreated patients with MBC. A previous treatment with taxanes does not preclude a good clinical response to this regimen.
authors.affiliation: Hellenic Oncology Research Group, 55 Lomvardou str, 11470 Athens, Greece.
authors.forename: N
authors.initials: N
authors.lastname: Karachaliou
authors.forename: Ch
authors.initials: Ch
authors.lastname: Kouroussis
authors.forename: P
authors.initials: P
authors.lastname: Papakotoulas
authors.forename: K
authors.initials: K
authors.lastname: Kalbakis
authors.forename: K
authors.initials: K
authors.lastname: Tryfonidis
authors.forename: N
authors.initials: N
authors.lastname: Vardakis
authors.forename: E
authors.initials: E
authors.lastname: Poppis
authors.forename: V
authors.initials: V
authors.lastname: Georgoulias
authors.forename: D
authors.initials: D
authors.lastname: Mavroudis
mesh_terms: D000328:Adult; D000368:Aged; D018943:Anthracyclines / Q000008:administration & dosage; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000031:analogs & derivatives; D000077143:Docetaxel; D005260:Female; D006801:Humans; D008875:Middle Aged; D009362:Neoplasm Metastasis; D016879:Salvage Therapy / Q000379:methods*; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D018943:Anthracyclines; D043823:Taxoids; D003841:Deoxycytidine; D000077143:Docetaxel; D000093542:Gemcitabine