title: Analysis of Ki-67 expression with neoadjuvant anastrozole or tamoxifen in patients receiving goserelin for premenopausal breast cancer.
abstract: BACKGROUND
  The increasing costs associated with large-scale adjuvant trials mean that the prognostic value of biologic markers is increasingly important. The expression of nuclear antigen Ki-67, a marker of cell proliferation, has been correlated with treatment efficacy and is being investigated for its value as a predictive marker of therapeutic response. In the current study, the authors explored correlations between Ki-67 expression and tumor response, estrogen receptor (ER) status, progesterone receptor (PgR) status, and histopathologic response from the STAGE study (S_tudy of T_amoxifen or A_rimidex, combined with G_oserelin acetate to compare E_fficacy and safety).
  
  
  METHODS
  In a phase 3, double-blind, randomized trial (National Clinical Trials identifier NCT00605267), premenopausal women with ER-positive, early stage breast cancer received either anastrozole plus goserelin or tamoxifen plus goserelin for 24 weeks before surgery. The Ki-67 index, hormone receptor (ER and PgR) status, and histopathologic responses were determined from histopathologic samples that were obtained from core-needle biopsies at baseline and at surgery. Tumor response was determined by using magnetic resonance imaging or computed tomography.
  
  
  RESULTS
  In total, 197 patients were randomized to receive either anastrozole plus goserelin (n = 98) or tamoxifen plus goserelin (n = 99). The best overall tumor response was better for the anastrozole group compared with the tamoxifen group both among patients who had a baseline Ki-67 index ≥20% and among those who had a baseline Ki-67 index <20%. There was no apparent correlation between baseline ER status and the Ki-67 index in either group. Positive PgR status was reduced from baseline to week 24 in the anastrozole group.
  
  
  CONCLUSIONS
  In premenopausal women with ER-positive breast cancer, anastrozole produced a greater best overall tumor response compared with tamoxifen regardless of the baseline Ki-67 index.
authors.affiliation: Department of Breast Oncology, Aichi Cancer Center Hospital, Aichi, Japan.
authors.forename: Hiroji
authors.initials: H
authors.lastname: Iwata
authors.forename: Norikazu
authors.initials: N
authors.lastname: Masuda
authors.forename: Yasuaki
authors.initials: Y
authors.lastname: Sagara
authors.forename: Takayuki
authors.initials: T
authors.lastname: Kinoshita
authors.forename: Seigo
authors.initials: S
authors.lastname: Nakamura
authors.forename: Yasuhiro
authors.initials: Y
authors.lastname: Yanagita
authors.forename: Reiki
authors.initials: R
authors.lastname: Nishimura
authors.forename: Hirotaka
authors.initials: H
authors.lastname: Iwase
authors.forename: Shunji
authors.initials: S
authors.lastname: Kamigaki
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Takei
authors.forename: Hitoshi
authors.initials: H
authors.lastname: Tsuda
authors.forename: Nobuya
authors.initials: N
authors.lastname: Hayashi
authors.forename: Shinzaburo
authors.initials: S
authors.lastname: Noguchi
mesh_terms: D000328:Adult; D000077384:Anastrozole; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use*; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000378:metabolism / Q000601:surgery; D004311:Double-Blind Method; D005260:Female; D017273:Goserelin / Q000008:administration & dosage / Q000627:therapeutic use; D006801:Humans; D019394:Ki-67 Antigen / Q000032:analysis / Q000378:metabolism*; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009570:Nitriles / Q000008:administration & dosage / Q000627:therapeutic use; D011237:Predictive Value of Tests; D017697:Premenopause; D011960:Receptors, Estrogen / Q000378:metabolism; D011980:Receptors, Progesterone / Q000378:metabolism; D013629:Tamoxifen / Q000008:administration & dosage / Q000627:therapeutic use; D016896:Treatment Outcome; D014230:Triazoles / Q000008:administration & dosage / Q000627:therapeutic use
chemical_list: D018931:Antineoplastic Agents, Hormonal; D019394:Ki-67 Antigen; D009570:Nitriles; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone; D014230:Triazoles; D013629:Tamoxifen; D017273:Goserelin; D000077384:Anastrozole