title: Using response to primary chemotherapy to select postoperative therapy: long-term results from a prospective phase II trial in locally advanced primary breast cancer.
abstract: OBJECTIVE
  This study sought to quantify the extent of downstaging after preoperative chemotherapy for stage III breast cancer, to assess the feasibility of breast-conserving therapy (BCT) after preoperative chemotherapy, to determine the effectiveness of this multimodal treatment as measured by disease-free survival (DFS) and overall survival (OS), and to evaluate toxicities.
  
  
  METHODS
  Patients were treated with 4 preoperative courses of 5-fluorouracil, doxorubicin, and cyclophosphamide (FAC). They were then evaluated for response to go to mastectomy or BCT. After local therapy, patients with an excellent response were treated with 4 additional cycles of FAC, whereas patients with a moderate response received 4 cycles of MV (methotrexate and vinblastine). A total of 203 patients were registered; 194 patients (96%) underwent surgery after chemotherapy.
  
  
  RESULTS
  The 5-year OS and progression-free survival rates were 89.8% and 81.6%, respectively, for patients with an excellent response to therapy compared with 67.2% and 63.5%, respectively, for patients with a moderate response and 55.3% and 48.8%, respectively, for patients considered nonresponders (P=.0005 for OS; P<.0001 for DFS). Cytopenia, nausea/vomiting, and stomatitis were the most common toxicities. Preoperative chemotherapy with FAC downstaged 88.6% of patients, and BCT was possible in >25%.
  
  
  CONCLUSIONS
  Response to preoperative chemotherapy was a prognostic factor in improved long-term survival.
authors.affiliation: Department of Breast Medical Oncology, University of Texas M. D. Anderson Cancer Center, Houston, TX 77230-1439, USA. agonzalez@mdanderson.org
authors.forename: Ana Maria
authors.initials: AM
authors.lastname: Gonzalez-Angulo
authors.forename: Ronald
authors.initials: R
authors.lastname: Walters
authors.forename: Kristine
authors.initials: K
authors.lastname: Broglio
authors.forename: Debbie K
authors.initials: DK
authors.lastname: Frye
authors.forename: Eric A
authors.initials: EA
authors.lastname: Strom
authors.forename: Richard L
authors.initials: RL
authors.lastname: Theriault
authors.forename: Daniel J
authors.initials: DJ
authors.lastname: Booser
authors.forename: Vicente
authors.initials: V
authors.lastname: Valero
authors.forename: Aman U
authors.initials: AU
authors.lastname: Buzdar
authors.forename: Gabriel N
authors.initials: GN
authors.lastname: Hortobagyi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy / Q000473:pathology / Q000601:surgery*; D003131:Combined Modality Therapy; D018572:Disease-Free Survival; D005260:Female; D006801:Humans; D008875:Middle Aged; D055815:Young Adult