title: Phase II trial of dose dense docetaxel followed by FEC100 as neoadjuvant chemotherapy in patients with operable breast cancer.
abstract: OBJECTIVE
  The aim of this study was to evaluate the efficacy and safety profile of 4 dose-dense cycles of docetaxel followed by 3 cycles of FEC100 neoadjuvant chemotherapy in patients with operable advanced breast cancer.
  
  
  METHODS
  Women were treated by 4 cycles of 100 mg/m² docetaxel every 2 weeks, followed by 3 cycles of FEC100 given every 3 weeks. The primary end point was pathologic complete response.
  
  
  RESULTS
  Forty-five patients were treated. Ninety-three percent of the patients completed the planned 7 chemotherapy courses. The median relative dose intensity for docetaxel, 5-fluorouracil, epirubicin, and cyclophosphamide were 0.98, 0.97, 0.96, and 0.97, respectively. There were no therapy-related deaths. Two patients stopped chemotherapy because of cutaneous toxicity. During the docetaxel sequence, the most common grade 3-4 toxicities were (% pts): neutropenia (13.3), grade 3: cutaneous (24.4), myalgia and arthralgia (6.7). No clinical cardiac toxicity was observed. The pathologic complete response rate was 21.4% and 26.2% using Sataloff and Chevallier classifications, respectively. The conservative surgery rate was 62.2%. The median follow-up was 38.5 months. Two and 3-year disease-free survival rates were 79% and 64%, respectively. Two- and 3-year overall survival rate were 93% and 88%, respectively.
  
  
  CONCLUSIONS
  This trial confirms the feasibility and efficacy of this dose dense docetaxel neoadjuvant regimen.
authors.affiliation: CRLC Val d'Aurelle, Montpellier, France. william.jacot@valdorel.fnclcc.fr
authors.forename: William
authors.initials: W
authors.lastname: Jacot
authors.forename: Frédéric
authors.initials: F
authors.lastname: Bibeau
authors.forename: Sophie
authors.initials: S
authors.lastname: Gourgou-Bourgade
authors.forename: Marian
authors.initials: M
authors.lastname: Gutowski
authors.forename: Pierre-Emmanuel
authors.initials: PE
authors.lastname: Colombo
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Bleuse
authors.forename: Andrew
authors.initials: A
authors.lastname: Kramar
authors.forename: Gilles
authors.initials: G
authors.lastname: Romieu
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000601:surgery*; D018572:Disease-Free Survival; D000077143:Docetaxel; D004305:Dose-Response Relationship, Drug; D004334:Drug Administration Schedule; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage / Q000009:adverse effects; D005500:Follow-Up Studies; D006801:Humans; D007262:Infusions, Intravenous; D008408:Mastectomy / Q000379:methods; D020714:Maximum Tolerated Dose; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009361:Neoplasm Invasiveness / Q000473:pathology; D009364:Neoplasm Recurrence, Local / Q000401:mortality / Q000473:pathology* / Q000628:therapy; D009367:Neoplasm Staging; D018570:Risk Assessment; D016019:Survival Analysis; D043823:Taxoids / Q000008:administration & dosage / Q000009:adverse effects; D013997:Time Factors; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D005472:Fluorouracil