title: Dose- intensified, preoperative and adjuvant chemotherapy in patients with T3- and T4- breast cancer: toxicity, clinical and pathological remission.
abstract: OBJECTIVE
  The aim of the study was to investigate a dose-intensified, preoperative chemotherapy with 3 cycles (cy) of epirubicin 60 mg/m2, ifosfamide 5 g/m2 with mesna 5 g/m2, biweekly with G-CSF 5 micrograms/kg (filgrastim), in terms of toxicity, clinical and pathological remission rates and changes of immunohistochemical characteristics (ER, PR, c-erbB2, p53) during chemotherapy of inoperable patients (pt) with poor prognosis (locally advanced (LABC, 9 pt), inflammatory breast cancer (IBC, 12 pt) and M0.
  
  
  METHODS
  Following preoperative chemotherapy (63 cy) and mastectomy patients received adjuvant 3 cy of epirubicin 60 mg/m2 and paclitaxel 175 mg/m2 (biweekly) with G-CSF (54 cy), and subsequently radiation of the thoracic wall and tamoxifen 20 mg/day.
  
  
  RESULTS
  Primary toxicity (T): grade 3 alopecia (21 pt), grade 3-4 leucopenia (7 cy), grade 1-2 leucopenia (26 cy), grade 1-2 anemia (61 cy), grade 1-2 neurocortical T (13 cy), grade 1-2 neurosensory T (7 cy), grade 1 cardiac toxicity (1 pt). ORR: 65% (CR: 0 pt, PR: 13 pt, NC: 8 pt). The grades of histological regression were: 0: 14 pt, 1: 6 pt, 2: 0 pt, 3: 1 pt. No significant correlation was observed between the clinical response and the histological regression (Fischer's exact test). The immunohistochemical expression of tumor characteristics did not change significantly during preoperative chemotherapy (Wilcoxon test). 81% of the pt were disease-free after a median follow-up of 20 months (7-26).
  
  
  CONCLUSIONS
  This therapy is safe, feasible and effective, both as primary and adjuvant chemotherapy in women with LABC and IBC.
authors.affiliation: Klinik für Frauenheilkunde und Geburtshilfe, Charité Berlin. jens-u.blohmer@charite.de
authors.forename: J U
authors.initials: JU
authors.lastname: Blohmer
authors.forename: S
authors.initials: S
authors.lastname: Paepke
authors.forename: L
authors.initials: L
authors.lastname: Kissner
authors.forename: D
authors.initials: D
authors.lastname: Elling
authors.forename: B
authors.initials: B
authors.lastname: Fleige
authors.forename: Y
authors.initials: Y
authors.lastname: Grineisen
authors.forename: W
authors.initials: W
authors.lastname: Lichtenegger
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000532:radiotherapy / Q000601:surgery; D017024:Chemotherapy, Adjuvant; D018572:Disease-Free Survival; D004305:Dose-Response Relationship, Drug; D015251:Epirubicin / Q000008:administration & dosage / Q000009:adverse effects; D005260:Female; D000069585:Filgrastim; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D007069:Ifosfamide / Q000008:administration & dosage / Q000009:adverse effects; D007150:Immunohistochemistry; D008408:Mastectomy; D015080:Mesna / Q000627:therapeutic use; D008875:Middle Aged; D009367:Neoplasm Staging; D017239:Paclitaxel / Q000008:administration & dosage / Q000009:adverse effects; D010865:Pilot Projects; D020011:Protective Agents / Q000627:therapeutic use; D011994:Recombinant Proteins; D016019:Survival Analysis; D013629:Tamoxifen / Q000008:administration & dosage / Q000009:adverse effects; D016896:Treatment Outcome
chemical_list: D020011:Protective Agents; D011994:Recombinant Proteins; D013629:Tamoxifen; D016179:Granulocyte Colony-Stimulating Factor; D015251:Epirubicin; D015080:Mesna; D017239:Paclitaxel; D000069585:Filgrastim; D007069:Ifosfamide