title: The effect on tumor response of adding sequential preoperative docetaxel to preoperative doxorubicin and cyclophosphamide: preliminary results from National Surgical Adjuvant Breast and Bowel Project Protocol B-27.
abstract: OBJECTIVE
  The National Surgical Adjuvant Breast and Bowel Project Protocol B-27 was designed to determine the effect of adding docetaxel after four cycles of preoperative doxorubicin and cyclophosphamide (AC) on clinical and pathological response rates and on disease-free and overall survival of women with operable breast cancer.
  
  
  METHODS
  Women (N = 2,411) with operable primary breast cancer were randomly assigned to receive either four cycles of preoperative AC followed by surgery (group I), or four cycles of AC followed by four cycles of docetaxel, followed by surgery (group II), or four cycles of AC followed by surgery and then four cycles of docetaxel (group III). Clinical and pathologic tumor responses to preoperative therapy were assessed.
  
  
  RESULTS
  Mean tumor size (4.5 cm) and other key characteristics were evenly balanced among the three treatment arms. Grade 4 toxicity was observed in 10.3% of 2,400 patients during AC treatment, and in 23.4% of 1584 patients during docetaxel treatment. Compared to preoperative AC alone, preoperative AC followed by docetaxel increased the clinical complete response rate (40.1% v 63.6%; P <.001), the overall clinical response rate (85.5% v 90.7%; P <.001), the pathologic complete response rate (13.7% v 26.1%; P <.001), and the proportion of patients with negative nodes (50.8% v 58.2%; P <.001). Pathologic primary breast tumor response was a significant predictor of pathologic nodal status (P <.001).
  
  
  CONCLUSIONS
  The addition of four cycles of preoperative docetaxel after four cycles of preoperative AC significantly increased clinical and pathologic response rates for operable breast cancer.
authors.affiliation: Virginia Commonwealth University, Medical College of Virginia School of Medicine, Richmond, VA, USA. hbear@hsc.vcu.edu
authors.forename: Harry D
authors.initials: HD
authors.lastname: Bear
authors.forename: Stewart
authors.initials: S
authors.lastname: Anderson
authors.forename: Ann
authors.initials: A
authors.lastname: Brown
authors.forename: Roy
authors.initials: R
authors.lastname: Smith
authors.forename: Eleftherios P
authors.initials: EP
authors.lastname: Mamounas
authors.forename: Bernard
authors.initials: B
authors.lastname: Fisher
authors.forename: Richard
authors.initials: R
authors.lastname: Margolese
authors.forename: Heather
authors.initials: H
authors.lastname: Theoret
authors.forename: Atilla
authors.initials: A
authors.lastname: Soran
authors.forename: D Lawrence
authors.initials: DL
authors.lastname: Wickerham
authors.forename: Norman
authors.initials: N
authors.lastname: Wolmark
mesh_terms: D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology* / Q000601:surgery; D003520:Cyclophosphamide / Q000008:administration & dosage; D000077143:Docetaxel; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D006801:Humans; D008408:Mastectomy; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000517:prevention & control*; D011300:Preoperative Care; D015996:Survival Rate; D043823:Taxoids / Q000008:administration & dosage; D016896:Treatment Outcome
chemical_list: D043823:Taxoids; D000077143:Docetaxel; D004317:Doxorubicin; D003520:Cyclophosphamide