title: Prospective Clinical Utility Study of the Use of the 21-Gene Assay in Adjuvant Clinical Decision Making in Women With Estrogen Receptor-Positive Early Invasive Breast Cancer: Results From the SWITCH Study.
abstract: BACKGROUND
  The 21-gene Oncotype DX Recurrence Score assay is a validated assay to help decide the appropriate treatment for estrogen receptor-positive (ER+), early-stage breast cancer (EBC) in the adjuvant setting. The choice of adjuvant treatments might vary considerably in different countries according to various treatment guidelines. This prospective multicenter study is the first to assess the impact of the Oncotype DX assay in the French clinical setting.
  
  
  METHODS
  A total of 100 patients with ER+, human epidermal growth factor receptor 2-negative EBC, and node-negative (pN0) disease or micrometastases in up to 3 lymph nodes (pN1mi) were enrolled. Treatment recommendations, physicians' confidence before and after knowing the Recurrence Score value, and physicians' perception of the assay were recorded.
  
  
  RESULTS
  Of the 100 patients, 95 were evaluable (83 pN0, 12 pN1mi). Treatment recommendations changed in 37% of patients, predominantly from chemoendocrine to endocrine treatment alone. The proportion of patients recommended chemotherapy decreased from 52% pretest to 25% post-test. Of patients originally recommended chemotherapy, 61% were recommended endocrine treatment alone after receiving the Recurrence Score result. For both pN0 and pN1mi patients, post-test recommendations appeared to follow the Recurrence Score result for low and high values. Physicians' confidence improved significantly.
  
  
  CONCLUSIONS
  These are the first prospective data on the impact of the Oncotype DX assay on adjuvant treatment decisions in France. Using the assay was associated with a significant change in treatment decisions and an overall reduction in chemotherapy use. These data are consistent with those presented from European and non-European studies.
authors.affiliation: APHP Tenon, IUC-UPMC, Sorbonne Université, Alliance Pour la Recherche en Cancérologie, Paris, France; University Hospital Jean Minjoz, UMR1098, SFR IBCT, Besançon, France; Institut du Cancer Montpellier, Université Montpellier 1, Montpellier, France; Centre Azuréen de Cancérologie, Mougins, France; Centre d'Oncologie de Gentilly, Nancy, France; APHP-St. Louis, Université Paris Diderot, Paris, France; Centre Jean-Perrin, Université d'Auvergne, Clermont-Ferrand, France; Research Unit EA 7285, University of Versailles St-Quentin, Montigny-le-Bretonneux, France; Department of Surgery, Institut Curie, Saint-Cloud, France joseph.gligorov@tnn.aphp.fr.
authors.forename: Joseph
authors.initials: J
authors.lastname: Gligorov
authors.affiliation: APHP Tenon, IUC-UPMC, Sorbonne Université, Alliance Pour la Recherche en Cancérologie, Paris, France; University Hospital Jean Minjoz, UMR1098, SFR IBCT, Besançon, France; Institut du Cancer Montpellier, Université Montpellier 1, Montpellier, France; Centre Azuréen de Cancérologie, Mougins, France; Centre d'Oncologie de Gentilly, Nancy, France; APHP-St. Louis, Université Paris Diderot, Paris, France; Centre Jean-Perrin, Université d'Auvergne, Clermont-Ferrand, France; Research Unit EA 7285, University of Versailles St-Quentin, Montigny-le-Bretonneux, France; Department of Surgery, Institut Curie, Saint-Cloud, France.
authors.forename: Xavier B
authors.initials: XB
authors.lastname: Pivot
authors.affiliation: APHP Tenon, IUC-UPMC, Sorbonne Université, Alliance Pour la Recherche en Cancérologie, Paris, France; University Hospital Jean Minjoz, UMR1098, SFR IBCT, Besançon, France; Institut du Cancer Montpellier, Université Montpellier 1, Montpellier, France; Centre Azuréen de Cancérologie, Mougins, France; Centre d'Oncologie de Gentilly, Nancy, France; APHP-St. Louis, Université Paris Diderot, Paris, France; Centre Jean-Perrin, Université d'Auvergne, Clermont-Ferrand, France; Research Unit EA 7285, University of Versailles St-Quentin, Montigny-le-Bretonneux, France; Department of Surgery, Institut Curie, Saint-Cloud, France.
authors.forename: William
authors.initials: W
authors.lastname: Jacot
authors.affiliation: APHP Tenon, IUC-UPMC, Sorbonne Université, Alliance Pour la Recherche en Cancérologie, Paris, France; University Hospital Jean Minjoz, UMR1098, SFR IBCT, Besançon, France; Institut du Cancer Montpellier, Université Montpellier 1, Montpellier, France; Centre Azuréen de Cancérologie, Mougins, France; Centre d'Oncologie de Gentilly, Nancy, France; APHP-St. Louis, Université Paris Diderot, Paris, France; Centre Jean-Perrin, Université d'Auvergne, Clermont-Ferrand, France; Research Unit EA 7285, University of Versailles St-Quentin, Montigny-le-Bretonneux, France; Department of Surgery, Institut Curie, Saint-Cloud, France.
authors.forename: Hervé L
authors.initials: HL
authors.lastname: Naman
authors.affiliation: APHP Tenon, IUC-UPMC, Sorbonne Université, Alliance Pour la Recherche en Cancérologie, Paris, France; University Hospital Jean Minjoz, UMR1098, SFR IBCT, Besançon, France; Institut du Cancer Montpellier, Université Montpellier 1, Montpellier, France; Centre Azuréen de Cancérologie, Mougins, France; Centre d'Oncologie de Gentilly, Nancy, France; APHP-St. Louis, Université Paris Diderot, Paris, France; Centre Jean-Perrin, Université d'Auvergne, Clermont-Ferrand, France; Research Unit EA 7285, University of Versailles St-Quentin, Montigny-le-Bretonneux, France; Department of Surgery, Institut Curie, Saint-Cloud, France.
authors.forename: Dominique
authors.initials: D
authors.lastname: Spaeth
authors.affiliation: APHP Tenon, IUC-UPMC, Sorbonne Université, Alliance Pour la Recherche en Cancérologie, Paris, France; University Hospital Jean Minjoz, UMR1098, SFR IBCT, Besançon, France; Institut du Cancer Montpellier, Université Montpellier 1, Montpellier, France; Centre Azuréen de Cancérologie, Mougins, France; Centre d'Oncologie de Gentilly, Nancy, France; APHP-St. Louis, Université Paris Diderot, Paris, France; Centre Jean-Perrin, Université d'Auvergne, Clermont-Ferrand, France; Research Unit EA 7285, University of Versailles St-Quentin, Montigny-le-Bretonneux, France; Department of Surgery, Institut Curie, Saint-Cloud, France.
authors.forename: Jean-Louis
authors.initials: JL
authors.lastname: Misset
authors.affiliation: APHP Tenon, IUC-UPMC, Sorbonne Université, Alliance Pour la Recherche en Cancérologie, Paris, France; University Hospital Jean Minjoz, UMR1098, SFR IBCT, Besançon, France; Institut du Cancer Montpellier, Université Montpellier 1, Montpellier, France; Centre Azuréen de Cancérologie, Mougins, France; Centre d'Oncologie de Gentilly, Nancy, France; APHP-St. Louis, Université Paris Diderot, Paris, France; Centre Jean-Perrin, Université d'Auvergne, Clermont-Ferrand, France; Research Unit EA 7285, University of Versailles St-Quentin, Montigny-le-Bretonneux, France; Department of Surgery, Institut Curie, Saint-Cloud, France.
authors.forename: Rémy
authors.initials: R
authors.lastname: Largillier
authors.affiliation: APHP Tenon, IUC-UPMC, Sorbonne Université, Alliance Pour la Recherche en Cancérologie, Paris, France; University Hospital Jean Minjoz, UMR1098, SFR IBCT, Besançon, France; Institut du Cancer Montpellier, Université Montpellier 1, Montpellier, France; Centre Azuréen de Cancérologie, Mougins, France; Centre d'Oncologie de Gentilly, Nancy, France; APHP-St. Louis, Université Paris Diderot, Paris, France; Centre Jean-Perrin, Université d'Auvergne, Clermont-Ferrand, France; Research Unit EA 7285, University of Versailles St-Quentin, Montigny-le-Bretonneux, France; Department of Surgery, Institut Curie, Saint-Cloud, France.
authors.forename: Jean-Loup
authors.initials: JL
authors.lastname: Sautiere
authors.affiliation: APHP Tenon, IUC-UPMC, Sorbonne Université, Alliance Pour la Recherche en Cancérologie, Paris, France; University Hospital Jean Minjoz, UMR1098, SFR IBCT, Besançon, France; Institut du Cancer Montpellier, Université Montpellier 1, Montpellier, France; Centre Azuréen de Cancérologie, Mougins, France; Centre d'Oncologie de Gentilly, Nancy, France; APHP-St. Louis, Université Paris Diderot, Paris, France; Centre Jean-Perrin, Université d'Auvergne, Clermont-Ferrand, France; Research Unit EA 7285, University of Versailles St-Quentin, Montigny-le-Bretonneux, France; Department of Surgery, Institut Curie, Saint-Cloud, France.
authors.forename: Anne
authors.initials: A
authors.lastname: de Roquancourt
authors.affiliation: APHP Tenon, IUC-UPMC, Sorbonne Université, Alliance Pour la Recherche en Cancérologie, Paris, France; University Hospital Jean Minjoz, UMR1098, SFR IBCT, Besançon, France; Institut du Cancer Montpellier, Université Montpellier 1, Montpellier, France; Centre Azuréen de Cancérologie, Mougins, France; Centre d'Oncologie de Gentilly, Nancy, France; APHP-St. Louis, Université Paris Diderot, Paris, France; Centre Jean-Perrin, Université d'Auvergne, Clermont-Ferrand, France; Research Unit EA 7285, University of Versailles St-Quentin, Montigny-le-Bretonneux, France; Department of Surgery, Institut Curie, Saint-Cloud, France.
authors.forename: Christophe
authors.initials: C
authors.lastname: Pomel
authors.affiliation: APHP Tenon, IUC-UPMC, Sorbonne Université, Alliance Pour la Recherche en Cancérologie, Paris, France; University Hospital Jean Minjoz, UMR1098, SFR IBCT, Besançon, France; Institut du Cancer Montpellier, Université Montpellier 1, Montpellier, France; Centre Azuréen de Cancérologie, Mougins, France; Centre d'Oncologie de Gentilly, Nancy, France; APHP-St. Louis, Université Paris Diderot, Paris, France; Centre Jean-Perrin, Université d'Auvergne, Clermont-Ferrand, France; Research Unit EA 7285, University of Versailles St-Quentin, Montigny-le-Bretonneux, France; Department of Surgery, Institut Curie, Saint-Cloud, France.
authors.forename: Philippe
authors.initials: P
authors.lastname: Rouanet
authors.affiliation: APHP Tenon, IUC-UPMC, Sorbonne Université, Alliance Pour la Recherche en Cancérologie, Paris, France; University Hospital Jean Minjoz, UMR1098, SFR IBCT, Besançon, France; Institut du Cancer Montpellier, Université Montpellier 1, Montpellier, France; Centre Azuréen de Cancérologie, Mougins, France; Centre d'Oncologie de Gentilly, Nancy, France; APHP-St. Louis, Université Paris Diderot, Paris, France; Centre Jean-Perrin, Université d'Auvergne, Clermont-Ferrand, France; Research Unit EA 7285, University of Versailles St-Quentin, Montigny-le-Bretonneux, France; Department of Surgery, Institut Curie, Saint-Cloud, France.
authors.forename: Roman
authors.initials: R
authors.lastname: Rouzier
authors.affiliation: APHP Tenon, IUC-UPMC, Sorbonne Université, Alliance Pour la Recherche en Cancérologie, Paris, France; University Hospital Jean Minjoz, UMR1098, SFR IBCT, Besançon, France; Institut du Cancer Montpellier, Université Montpellier 1, Montpellier, France; Centre Azuréen de Cancérologie, Mougins, France; Centre d'Oncologie de Gentilly, Nancy, France; APHP-St. Louis, Université Paris Diderot, Paris, France; Centre Jean-Perrin, Université d'Auvergne, Clermont-Ferrand, France; Research Unit EA 7285, University of Versailles St-Quentin, Montigny-le-Bretonneux, France; Department of Surgery, Institut Curie, Saint-Cloud, France.
authors.forename: Frederique M
authors.initials: FM
authors.lastname: Penault-Llorca
mesh_terms: D000328:Adult; D000368:Aged; D001681:Biological Assay / Q000379:methods*; D001943:Breast Neoplasms / Q000188:drug therapy / Q000235:genetics*; D017024:Chemotherapy, Adjuvant / Q000379:methods*; D005260:Female; D006801:Humans; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local; D011446:Prospective Studies; D011960:Receptors, Estrogen / Q000378:metabolism*
chemical_list: D011960:Receptors, Estrogen
keywords: Adjuvant; Chemotherapy; Early breast cancer; Estrogen receptor-positive