title: The use of alternate, non-cross-resistant adjuvant chemotherapy on the basis of pathologic response to a neoadjuvant doxorubicin-based regimen in women with operable breast cancer: long-term results from a prospective randomized trial.
abstract: OBJECTIVE
  To evaluate the use of an alternate, non-cross-resistant adjuvant chemotherapy regimen in women with a poor pathologic response to a preoperative doxorubicin-based regimen.
  
  
  METHODS
  Patients with locally advanced breast cancer received three cycles of vincristine, doxorubicin, cyclophosphamide, and prednisone (VACP) every 21 days followed by surgery. Patients with less than 1 cm(3) residual tumor at mastectomy received an additional five cycles of VACP. Those with more than 1 cm(3) residual tumor were randomly assigned to receive an additional five cycles of VACP or five cycles of vinblastine, methotrexate with calcium leucovorin rescue, and fluorouracil (VbMF).
  
  
  RESULTS
  One hundred ninety-three patients were evaluable. Overall clinical response was seen in 83.4% after three cycles of VACP, whereas the pathologic complete response was 12.2%. One hundred six patients were randomly assigned to VACP or VbMF. Those receiving VbMF achieved higher relapse-free survival (RFS) and overall survival (OS) than those who received additional VACP, although the differences did not reach statistical significance. Initial stage of tumor, clinical complete response, and pathologic complete response were all associated with statistically superior survival rates.
  
  
  CONCLUSIONS
  Clinical and pathologic response to preoperative doxorubicin-based chemotherapy predicted for improved survival in women with operable breast cancer. For those with a poor response to initial neoadjuvant chemotherapy, treatment with VbMF was associated with a trend toward improved RFS and OS compared with those continuing with the doxorubicin regimen.
authors.affiliation: The University of Texas MD Anderson Cancer Center, Houston, TX 77030, USA. ethomas@mdanderson.org
authors.forename: Eva
authors.initials: E
authors.lastname: Thomas
authors.forename: Frankie A
authors.initials: FA
authors.lastname: Holmes
authors.forename: Terry L
authors.initials: TL
authors.lastname: Smith
authors.forename: Aman U
authors.initials: AU
authors.lastname: Buzdar
authors.forename: Debra K
authors.initials: DK
authors.lastname: Frye
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Fraschini
authors.forename: S Eva
authors.initials: SE
authors.lastname: Singletary
authors.forename: Richard L
authors.initials: RL
authors.lastname: Theriault
authors.forename: Marsha D
authors.initials: MD
authors.lastname: McNeese
authors.forename: Frederick
authors.initials: F
authors.lastname: Ames
authors.forename: Ronald
authors.initials: R
authors.lastname: Walters
authors.forename: Gabriel N
authors.initials: GN
authors.lastname: Hortobagyi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001943:Breast Neoplasms / Q000628:therapy*; D017024:Chemotherapy, Adjuvant; D003131:Combined Modality Therapy; D004317:Doxorubicin / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D015996:Survival Rate
chemical_list: D004317:Doxorubicin