title: Menopausal status does not predict Oncotype DX recurrence score.
abstract: BACKGROUND
  Adjuvant treatment for early stage, estrogen receptor (ER) positive invasive breast cancer has been based on prognosticators such as menopausal status. The recurrence score (RS) from the 21-gene assay Oncotype DX (ODX) is predictive of a 10-y distant recurrence in this population but is rarely applied to premenopausal patients. The relationship between menopausal status and RS was evaluated.
  
  
  METHODS
  An institutional review board-approved retrospective review was conducted of invasive breast cancer patients with known RS. ODX eligibility was based on National Comprehensive Cancer Network guidelines or physician discretion. Perimenopausal women were classified as premenopausal for statistical analyses. Comparisons of menopausal status and RS were made using general linear regression model and the exact Wilcoxon rank-sum test.
  
  
  RESULTS
  Menopausal status was available for 575 patients (142 premenopausal, 433 postmenopausal). Median age was 46 y for premenopausal and 62 y for postmenopausal. Median invasive tumor size was 1.5 cm for both cohorts. Mastectomy rate was higher in the premenopausal group (54.8%) than postmenopausal (42%; P = 0.0001). Premenopausal women had a higher local-regional recurrence rate (2.8% versus 0%; P = 0.0384) but distant recurrence and overall survival were not statistically different (P = 0.6808). Median ER H-score was lower in premenopausal (H-score = 270) than postmenopausal women (H-score = 280; P < 0.0001). Median RS was 16 for both premenopausal (range, 0-54) and postmenopausal (range, 0-63) women. Menopausal status as a categorical variable was not predictive of RS (P-value = 0.6780).
  
  
  CONCLUSIONS
  Menopausal status has limited predictive power for distant recurrence. Therefore, menopausal status alone should not preclude performance of ODX in ER-positive, early stage breast cancer.
authors.affiliation: Morsani College of Medicine, University of South Florida, Tampa Florida.
authors.forename: Danielle N
authors.initials: DN
authors.lastname: Carr
authors.affiliation: Morsani College of Medicine, University of South Florida, Tampa Florida.
authors.forename: Nora
authors.initials: N
authors.lastname: Vera
authors.affiliation: Department of Breast Oncology, Comprehensive Breast Program, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
authors.forename: Weihong
authors.initials: W
authors.lastname: Sun
authors.affiliation: Department of Breast Oncology, Comprehensive Breast Program, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida; Department of Oncologic Science, University of South Florida, Tampa, Florida; Department of Surgery, University of South Florida, Tampa, Florida.
authors.forename: Marie Catherine
authors.initials: MC
authors.lastname: Lee
authors.affiliation: Department of Breast Oncology, Comprehensive Breast Program, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida; Department of Oncologic Science, University of South Florida, Tampa, Florida; Department of Surgery, University of South Florida, Tampa, Florida.
authors.forename: Susan
authors.initials: S
authors.lastname: Hoover
authors.affiliation: Division of Biostatistics, Department of Biostatics, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida.
authors.forename: William
authors.initials: W
authors.lastname: Fulp
authors.affiliation: Women's Pathology Consultants, Ruffolo Hooper and Associates, Tampa, Florida.
authors.forename: Geza
authors.initials: G
authors.lastname: Acs
authors.affiliation: Department of Breast Oncology, Comprehensive Breast Program, H. Lee Moffitt Cancer Center and Research Institute, Tampa, Florida; Department of Oncologic Science, University of South Florida, Tampa, Florida; Department of Surgery, University of South Florida, Tampa, Florida. Electronic address: christine.laronga@moffitt.org.
authors.forename: Christine
authors.initials: C
authors.lastname: Laronga
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000737:chemistry / Q000209:etiology / Q000235:genetics*; D005260:Female; D005838:Genotype; D006801:Humans; D008593:Menopause; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000737:chemistry / Q000209:etiology / Q000235:genetics*; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis; D011960:Receptors, Estrogen / Q000032:analysis; D012189:Retrospective Studies
chemical_list: D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; C508053:ERBB2 protein, human
keywords: Adjuvant therapy; Breast cancer; Oncotype DX; Premenopausal; Recurrence