title: A phase II study of docetaxel, doxorubicin, and infusional 5-fluorouracil in the treatment of patients with locally advanced breast cancer.
abstract: OBJECTIVE
  The primary aim of this study was to estimate the rate of clinical and pathologic response to preoperative docetaxel, doxorubicin, and infusional 5-fluorouracil in patients with locally advanced breast cancer. Secondary objective included the determination of toxicity profile.
  
  
  METHODS
  Thirty-nine patients (median age 49 years) with histologically confirmed locally advanced breast cancer (stage IIIA or IIIB) were studied. Patients received 4 courses of chemotherapy with docetaxel (75 mg/m2 iv over 1 hour), doxorubicin (50 mg/m2 iv bolus), and 5-fluorouracil (300 mg/m2/d as continuous iv infusion on days 1-5). Treatment cycles were repeated every 21 days. Prophylactic filgastrim 5 microg/kg s/c QD was administered to all patients. Definitive surgery was performed after the completion of 4 cycles of therapy. Pathologic complete response was defined as the absence of invasive cancer in both the breast and ipsilateral axillary lymph nodes.
  
  
  RESULTS
  The clinical objective response rate (partial plus complete) was 87% (95% confidence interval [CI]: 76-98%). Three patients (8%) had complete pathologic response. Two patients progressed preoperatively. Thirteen patients (33%) developed neutropenic fever. Fifty-three percent of the patients were hospitalized for treatment related complications. No cardiotoxicity or treatment related deaths were observed.
  
  
  CONCLUSIONS
  Triple cytotoxic therapy based on concurrent doxorubicin and docetaxel with infusional 5-flourouracil (5-FU) does not appear to significantly improve the pathologic response in patients with locally advanced breast cancer.
authors.affiliation: Karmanos Cancer Institute, Wayne State University, Detroit, MI 48201, USA.
authors.forename: Lata Chandi
authors.initials: LC
authors.lastname: Thatai
authors.forename: Priya
authors.initials: P
authors.lastname: Vishnubhotla
authors.forename: Laura
authors.initials: L
authors.lastname: Biernat
authors.forename: Lawrence
authors.initials: L
authors.lastname: Flaherty
authors.forename: Patricia
authors.initials: P
authors.lastname: LoRusso
authors.forename: Michael
authors.initials: M
authors.lastname: Simon
authors.forename: Deanna
authors.initials: D
authors.lastname: Stephens
authors.forename: Kelly
authors.initials: K
authors.lastname: Vereeke
authors.forename: Judith
authors.initials: J
authors.lastname: Abrams
authors.forename: David
authors.initials: D
authors.lastname: Bouwman
authors.forename: Philip A
authors.initials: PA
authors.lastname: Philip
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy*; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D000069585:Filgrastim; D005472:Fluorouracil / Q000008:administration & dosage; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use; D006801:Humans; D007262:Infusions, Intravenous; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D011994:Recombinant Proteins; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D011994:Recombinant Proteins; D043823:Taxoids; D016179:Granulocyte Colony-Stimulating Factor; D000077143:Docetaxel; D004317:Doxorubicin; D000069585:Filgrastim; D005472:Fluorouracil