title: Docetaxel in combination with mitoxantrone and granulocyte colony-stimulating factor as front-line chemotherapy in metastatic breast cancer: a multicenter phase II study.
abstract: OBJECTIVE
  To evaluate the activity and tolerance of docetaxel in combination with mitoxantrone and granulocyte colony-stimulating factor (G-CSF) as front-line treatment in patients with metastatic breast cancer (MBC).
  
  
  METHODS
  Fifty-four previously untreated patients with MBC who had bidimensionally measurable disease were enrolled onto the study. Forty-eight (89%) patients had visceral metastases and nineteen (36%) had relapsed within twelve months following adjuvant chemotherapy. Docetaxel (100 mg/m2) was given on day 1 after appropriate premedication and mitoxantrone (20 mg/m2) on day 8. G-CSF (150 mcg/m2/d s.c.) was administered from day 2 to day 6 and from day 9 to day 15. The regimen was repeated every three weeks, on an outpatient basis.
  
  
  RESULTS
  In an intention-to-treat analysis, 9 (17%) CRs, 24 (44%) PRs, (overall response rate 61%; 95% confidence interval (CI): 48.1%-74.1%), 12 (22%) SD and 9 (17%) PD were observed. The median duration of response and the median time to tumor progression was 12.5 and 14 months, respectively. The overall median survival was 16.5 months, whilst the probability for one- and three-year survival was 61% and 35%, respectively. Grade 3-4 neutropenia occurred in 37 (69%) patients, and febrile neutropenia in 16 (30%); there was one death due to sepsis. Grade 3-4 thrombocytopenia occurred in four (8%) patients. Grade 2-3 neurosensory toxicity was observed in 8 (15%) patients and grade 2-3 asthenia in 24 (45%).
  
  
  CONCLUSIONS
  Docetaxel in combination with mitoxantrone and G-CSF support is an intensified and active front-line regimen for patients with MBC; despite its hematological toxicity, this regimen merits further comparison with other standard anthracycline- and/or taxane-based combinations.
authors.affiliation: Second Department of Medical Oncology, Agios Savas Anticancer Hospital of Athens, Greece.
authors.forename: A
authors.initials: A
authors.lastname: Alexopoulos
authors.forename: C
authors.initials: C
authors.lastname: Kouroussis
authors.forename: N
authors.initials: N
authors.lastname: Malamos
authors.forename: S
authors.initials: S
authors.lastname: Kakolyris
authors.forename: K
authors.initials: K
authors.lastname: Kalbakis
authors.forename: C
authors.initials: C
authors.lastname: Kosmas
authors.forename: D
authors.initials: D
authors.lastname: Mavroudis
authors.forename: S
authors.initials: S
authors.lastname: Agelaki
authors.forename: J
authors.initials: J
authors.lastname: Vlachonicolis
authors.forename: E
authors.initials: E
authors.lastname: Sarra
authors.forename: G
authors.initials: G
authors.lastname: Rigatos
authors.forename: V
authors.initials: V
authors.lastname: Georgoulias
mesh_terms: D000284:Administration, Oral; D000328:Adult; D000368:Aged; D000505:Alopecia / Q000139:chemically induced; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality; D000077143:Docetaxel; D004334:Drug Administration Schedule; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage*; D006801:Humans; D008875:Middle Aged; D008942:Mitoxantrone / Q000008:administration & dosage*; D009325:Nausea / Q000139:chemically induced; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage* / Q000009:adverse effects / Q000031:analogs & derivatives*; D018805:Sepsis / Q000150:complications / Q000401:mortality; D015996:Survival Rate; D043823:Taxoids
chemical_list: D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D008942:Mitoxantrone; D017239:Paclitaxel