title: Results of a prospective study with high-dose etoposide, thiotepa and carboplatin and peripheral blood stem cell rescue for high-risk stage II-IIIA and selected stage IV breast cancer patients.
abstract: OBJECTIVE
  To investigate the safety and efficacy of a high-dose chemotherapy regimen with etoposide, carboplatin and thiotepa in high-risk stage II-IIIA breast cancer and in responsive metastatic patients.
  
  
  METHODS
  From April 1992 to December 1998, 24 patients with high-risk stage II-IIIA breast cancer (> or = 9 positive nodes) and 9 responsive metastatic patients were enrolled in the trial. After induction chemotherapy with an anthracycline-based regimen, peripheral blood stem cells were mobilized with cyclophosphamide (7 g/m2) and G-CSF (5-16 microg/kg/s.c./day). The high-dose chemotherapy regimen consisted of etoposide (1000 mg/m2), carboplatin (800 mg/m2) and thiotepa (500 mg/m2). At the end of the high-dose chemotherapy, all stage II-IIIA patients received radiotherapy to the breast or chest wall and draining nodes; stage IV patients were irradiated to sites of disease, if feasible. All ER+ and/or PgR+ patients were treated with hormone therapy.
  
  
  RESULTS
  For stage II-IIIA high-risk patients, the median follow-up was 4.36 years (range, 1.93-6.94), and the Kaplan-Meier estimate at 5 years of disease-free survival and overall survival was 54.8 +/- 11% SE and 76.73 +/- 9.4% SE, respectively. For metastatic patients, the median follow-up was 4.93 years (range, 4.15-7.95), and the Kaplan-Meier estimate at 5 years of progression-free survival and overall survival was 22.2 +/- 13.9% SE and 76.2 +/- 14.8% SE, respectively. No treatment-related deaths were observed.
  
  
  CONCLUSIONS
  Our results are comparable to those obtained in other high-dose chemotherapy trials but do not seem to be superior to conventional-dose therapy given to similar patients.
authors.affiliation: Medical Oncology Division, Policlinico Hospital, Perugia, Italy.
authors.forename: S
authors.initials: S
authors.lastname: Gori
authors.forename: A M
authors.initials: AM
authors.lastname: Mosconi
authors.forename: A
authors.initials: A
authors.lastname: Tabilio
authors.forename: F
authors.initials: F
authors.lastname: Falzetti
authors.forename: C
authors.initials: C
authors.lastname: Aristei
authors.forename: C
authors.initials: C
authors.lastname: Basurto
authors.forename: R
authors.initials: R
authors.lastname: Cherubini
authors.forename: P
authors.initials: P
authors.lastname: Latini
authors.forename: M F
authors.initials: MF
authors.lastname: Martelli
authors.forename: M
authors.initials: M
authors.lastname: Tonato
authors.forename: M
authors.initials: M
authors.lastname: Colozza
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology*; D016190:Carboplatin / Q000008:administration & dosage; D004334:Drug Administration Schedule; D005047:Etoposide / Q000008:administration & dosage; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D012306:Risk; D013852:Thiotepa / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D005047:Etoposide; D013852:Thiotepa; D016190:Carboplatin