title: Preoperative FLAC/granulocyte-colony-stimulating factor chemotherapy for stage II breast cancer: a prospective randomized trial.
abstract: BACKGROUND
  Preoperative chemotherapy for stage II breast cancer may reduce locoregional tumors and provides initial treatment for systemic micrometastases. We conducted a prospective, randomized trial to evaluate the ability of intensive preoperative chemotherapy to enhance the outcome of this approach.
  
  
  METHODS
  Patients with clinical stage II breast cancer (T2N0, T1N1, and T2N1) were prospectively randomized to receive either preoperative or postoperative chemotherapy with five 21-day cycles of fluorouracil, leucovorin calcium, doxorubicin, and cyclophosphamide (FLAC)/granulocyte-colony-stimulating factor. Local therapy consisted of modified radical mastectomy or segmentectomy/axillary dissection/breast radiotherapy, according to patient preference.
  
  
  RESULTS
  Fifty-three women were randomized (26 preoperative chemotherapy and 27 postoperative chemotherapy). The objective clinical response rate of the primary tumor to preoperative chemotherapy was 80%, and the pathologic complete response rate was 20%. Preoperative chemotherapy reduced the overall incidence and number of axillary lymph node metastases. There was no difference in the use of breast-conserving local therapy between the two treatment arms. There were 20 local/regional or distant recurrences (9 preoperative and 11 postoperative). There was no difference in the overall or disease-free survival between the preoperative and postoperative chemotherapy arms.
  
  
  CONCLUSIONS
  Preoperative FLAC/granulocyte-colony-stimulating factor chemotherapy was effective against local/regional tumors in stage II breast cancer but was otherwise comparable to postoperative chemotherapy.
authors.affiliation: Surgery Branch, Center for Cancer Research of the National Cancer Institute, Bethesda, Maryland, USA. david_danforth@nih.gov
authors.forename: David N
authors.initials: DN
authors.lastname: Danforth
authors.forename: Kenneth
authors.initials: K
authors.lastname: Cowan
authors.forename: Rosemary
authors.initials: R
authors.lastname: Altemus
authors.forename: Maria
authors.initials: M
authors.lastname: Merino
authors.forename: Catherine
authors.initials: C
authors.lastname: Chow
authors.forename: Arlene
authors.initials: A
authors.lastname: Berman
authors.forename: Usha
authors.initials: U
authors.lastname: Chaudhry
authors.forename: Craig
authors.initials: C
authors.lastname: Shriver
authors.forename: Seth M
authors.initials: SM
authors.lastname: Steinberg
authors.forename: JoAnne
authors.initials: J
authors.lastname: Zujewski
mesh_terms: D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000473:pathology / Q000601:surgery*; D003131:Combined Modality Therapy; D003520:Cyclophosphamide / Q000008:administration & dosage; D018572:Disease-Free Survival; D004317:Doxorubicin / Q000008:administration & dosage; D005260:Female; D005472:Fluorouracil / Q000008:administration & dosage; D016179:Granulocyte Colony-Stimulating Factor / Q000008:administration & dosage; D016178:Granulocyte-Macrophage Colony-Stimulating Factor / Q000008:administration & dosage; D006801:Humans; D007262:Infusions, Intravenous; D007275:Injections, Intravenous; D007279:Injections, Subcutaneous; D002955:Leucovorin / Q000008:administration & dosage; D008408:Mastectomy; D015412:Mastectomy, Segmental; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D011379:Prognosis; D018714:Radiotherapy, Adjuvant; D016896:Treatment Outcome
chemical_list: D016179:Granulocyte Colony-Stimulating Factor; D004317:Doxorubicin; D016178:Granulocyte-Macrophage Colony-Stimulating Factor; D003520:Cyclophosphamide; D002955:Leucovorin; D005472:Fluorouracil