title: Treatment of advanced breast cancer with docetaxel and gemcitabine with and without human granulocyte colony-stimulating factor.
abstract: OBJECTIVE
  A multicenter Phase II trial was performed to investigate the efficacy and tolerance of combined docetaxel and gemcitabine +/- recombinant human granulocyte colony-stimulating factor (G-CSF) in patients with metastatic breast cancer.
  
  
  METHODS
  Fifty-two patients participated in this trial, 51 of whom are evaluable for response. Thirty-eight patients received this combination as first-line chemotherapy, and 14 patients received this combination as second-line chemotherapy, including 10 patients who had failed anthracyclines. Therapy consisted of 1500 mg/m2 gemcitabine and 50 mg/m2 docetaxel, both administered on days 1 and 15 every 4 weeks. Depending on the absolute neutrophil counts on the day of scheduled chemotherapeutic drug administration, a 5-day course of 5 microg/kg G-CSF was given.
  
  
  RESULTS
  The overall response rate was 60.5% (95% confidence interval, 43.4-75.9%) in patients receiving docetaxel plus gemcitabine as first-line chemotherapy, including 4 complete responses (10.5%) and 19 partial remissions (50%); 9 patients (24%) had disease stabilization, and only 5 (13%) progressed. Second-line treatment with this regimen resulted in 6 of 14 (43%) objective responses, 5 had stable disease, and 3 progressive disease. The median time to progression was 8.5 months in the first-line setting and 6.6 months in the second-line setting, respectively. After a median follow-up time of 15 months, 36 patients (69%) are still alive with metastatic disease. Myelosuppression was commonly observed; WHO grade 3 or 4 neutropenia, however, occurred in only 15 (29%) patients and was complicated by septicemia in 2 cases; grade 3 anemia was seen in 1 patient (2%). Severe (grade 3) nonhematological toxicity except for alopecia was rarely observed and included nausea/vomiting in 3 (6%), stomatitis in 2 (4%), anaphylaxis in 2, and peripheral neuropathy, skin toxicity, and increase of liver enzymes each in one patient.
  
  
  CONCLUSIONS
  Our data suggest that docetaxel and gemcitabine with and without G-CSF is an effective and fairly well-tolerated regimen for the treatment of advanced breast cancer. It might be particularly useful in patients exposed previously to adjuvant or palliative anthracyclines and/or alkylating agents.
authors: Department of Internal Medicine I, Division of Oncology, Vienna University Medical School, Waehringer Guertel 18-20, A-1090 Vienna. gabriela.kornek@akh-wien.ac.at
authors: Gabriela V
authors: GV
authors: Kornek
authors: Karin
authors: K
authors: Haider
authors: Werner
authors: W
authors: Kwasny
authors: Markus
authors: M
authors: Raderer
authors: Birgit
authors: B
authors: Schüll
authors: Thomas
authors: T
authors: Payrits
authors: Dieter
authors: D
authors: Depisch
authors: Erwin
authors: E
authors: Kovats
authors: Fritz
authors: F
authors: Lang
authors: Werner
authors: W
authors: Scheithauer
mesh_terms: D000328:Adult; D000368:Aged; D000740:Anemia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology; D003841:Deoxycytidine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D000077143:Docetaxel; D005221:Fatigue / Q000139:chemically induced; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage / Q000009:adverse effects; D006801:Humans; D007970:Leukopenia / Q000139:chemically induced; D008875:Middle Aged; D009325:Nausea / Q000139:chemically induced; D009422:Nervous System Diseases / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives*; D016019:Survival Analysis; D043823:Taxoids; D016896:Treatment Outcome; D000093542:Gemcitabine
chemical_list: D043823:Taxoids; D003841:Deoxycytidine; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D017239:Paclitaxel; D000093542:Gemcitabine