title: Docetaxel plus epidoxorubicin as neoadjuvant treatment in patients with large operable or locally advanced carcinoma of the breast: a single-center, phase II study.
abstract: BACKGROUND
  The objective of this study was to test the activity and toxicity of epirubicin plus docetaxel as primary chemotherapy for women with large, operable (T2; > 3 cm) or locally advanced (Stage III) breast carcinoma, including patients with inflammatory breast carcinoma.
  
  
  METHODS
  In this single-center, open-label, single-stage, Phase II trial, epirubicin (75 mg/m(2); intravenous bolus) followed by docetaxel (80 mg/m(2); 1-hour intravenous infusion) was administered on Day 1 of each cycle for four cycles.
  
  
  RESULTS
  Nine of 30 patients (30%) had inflammatory breast carcinoma. Twenty-three patients (76.7%; 95% confidence interval, 57.7-90.1) had a clinical objective response that was complete in 6 patients (20%). Twenty-seven patients (90%) underwent surgery that was conservative in 5 patients (16.7%). Pathologic response evaluation revealed four complete responses (13.3%; 95% confidence interval, 3.8-30.7). Grade 4 neutropenia was recorded in 80.0% of patients, and febrile neutropenia was recorded in one-third of patients. Anemia and thrombocytopenia were never severe. Other side effects were diarrhea (26.6%), oral mucositis (43.3%), and emesis (26.6%).
  
  
  CONCLUSIONS
  Neoadjuvant chemotherapy with epirubicin plus docetaxel was a feasible treatment and was active in an unfavorable series of patients with locally advanced breast carcinoma, including patients with inflammatory breast carcinoma.
authors.affiliation: Department of Medical Oncology C, National Cancer Institute, Naples, Italy. f.conuzzo@libero.it
authors.forename: Andrea
authors.initials: A
authors.lastname: de Matteis
authors.forename: Francesco
authors.initials: F
authors.lastname: Nuzzo
authors.forename: Giuseppe
authors.initials: G
authors.lastname: D'Aiuto
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Labonia
authors.forename: Gabriella
authors.initials: G
authors.lastname: Landi
authors.forename: Emanuela
authors.initials: E
authors.lastname: Rossi
authors.forename: Angelo Antonio
authors.initials: AA
authors.lastname: Mastro
authors.forename: Gerardo
authors.initials: G
authors.lastname: Botti
authors.forename: Ermelinda
authors.initials: E
authors.lastname: De Maio
authors.forename: Francesco
authors.initials: F
authors.lastname: Perrone
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery; D000077143:Docetaxel; D015251:Epirubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009503:Neutropenia / Q000139:chemically induced; D017239:Paclitaxel / Q000008:administration & dosage / Q000031:analogs & derivatives*; D043823:Taxoids; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D015251:Epirubicin; D017239:Paclitaxel