title: American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer (unabridged version).
abstract: OBJECTIVE
  To develop a guideline to improve the accuracy of immunohistochemical (IHC) estrogen receptor (ER) and progesterone receptor (PgR) testing in breast cancer and the utility of these receptors as predictive markers.
  
  
  METHODS
  The American Society of Clinical Oncology and the College of American Pathologists convened an international Expert Panel that conducted a systematic review and evaluation of the literature in partnership with Cancer Care Ontario and developed recommendations for optimal IHC ER/PgR testing performance.
  
  
  RESULTS
  Up to 20% of current IHC determinations of ER and PgR testing worldwide may be inaccurate (false negative or false positive). Most of the issues with testing have occurred because of variation in pre-analytic variables, thresholds for positivity, and interpretation criteria.
  
  
  CONCLUSIONS
  The Panel recommends that ER and PgR status be determined on all invasive breast cancers and breast cancer recurrences. A testing algorithm that relies on accurate, reproducible assay performance is proposed. Elements to reliably reduce assay variation are specified. It is recommended that ER and PgR assays be considered positive if there are at least 1% positive tumor nuclei in the sample on testing in the presence of expected reactivity of internal (normal epithelial elements) and external controls. The absence of benefit from endocrine therapy for women with ER-negative invasive breast cancers has been confirmed in large overviews of randomized clinical trials.
authors.affiliation: Intermountain Healthcare, University of Utah School of Medicine, Salt Lake City, UT, USA.
authors.forename: M Elizabeth H
authors.initials: ME
authors.lastname: Hammond
authors.forename: Daniel F
authors.initials: DF
authors.lastname: Hayes
authors.forename: Mitch
authors.initials: M
authors.lastname: Dowsett
authors.forename: D Craig
authors.initials: DC
authors.lastname: Allred
authors.forename: Karen L
authors.initials: KL
authors.lastname: Hagerty
authors.forename: Sunil
authors.initials: S
authors.lastname: Badve
authors.forename: Patrick L
authors.initials: PL
authors.lastname: Fitzgibbons
authors.forename: Glenn
authors.initials: G
authors.lastname: Francis
authors.forename: Neil S
authors.initials: NS
authors.lastname: Goldstein
authors.forename: Malcolm
authors.initials: M
authors.lastname: Hayes
authors.forename: David G
authors.initials: DG
authors.lastname: Hicks
authors.forename: Susan
authors.initials: S
authors.lastname: Lester
authors.forename: Richard
authors.initials: R
authors.lastname: Love
authors.forename: Pamela B
authors.initials: PB
authors.lastname: Mangu
authors.forename: Lisa
authors.initials: L
authors.lastname: McShane
authors.forename: Keith
authors.initials: K
authors.lastname: Miller
authors.forename: C Kent
authors.initials: CK
authors.lastname: Osborne
authors.forename: Soonmyung
authors.initials: S
authors.lastname: Paik
authors.forename: Jane
authors.initials: J
authors.lastname: Perlmutter
authors.forename: Anthony
authors.initials: A
authors.lastname: Rhodes
authors.forename: Hironobu
authors.initials: H
authors.lastname: Sasano
authors.forename: Jared N
authors.initials: JN
authors.lastname: Schwartz
authors.forename: Fred C G
authors.initials: FC
authors.lastname: Sweep
authors.forename: Sheila
authors.initials: S
authors.lastname: Taube
authors.forename: Emina Emilia
authors.initials: EE
authors.lastname: Torlakovic
authors.forename: Paul
authors.initials: P
authors.lastname: Valenstein
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Viale
authors.forename: Daniel
authors.initials: D
authors.lastname: Visscher
authors.forename: Thomas
authors.initials: T
authors.lastname: Wheeler
authors.forename: R Bruce
authors.initials: RB
authors.lastname: Williams
authors.forename: James L
authors.initials: JL
authors.lastname: Wittliff
authors.forename: Antonio C
authors.initials: AC
authors.lastname: Wolff
mesh_terms: D000465:Algorithms; D014408:Biomarkers, Tumor / Q000032:analysis; D001943:Breast Neoplasms / Q000737:chemistry* / Q000188:drug therapy / Q000473:pathology; D005188:False Negative Reactions; D005189:False Positive Reactions; D005260:Female; D006801:Humans; D007150:Immunohistochemistry / Q000592:standards*; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local; D011960:Receptors, Estrogen / Q000032:analysis*; D011980:Receptors, Progesterone / Q000032:analysis*; D015203:Reproducibility of Results; D017211:Treatment Failure
chemical_list: D014408:Biomarkers, Tumor; D011960:Receptors, Estrogen; D011980:Receptors, Progesterone