title: In the era of genomics, should tumor size be reconsidered as a criterion for neoadjuvant chemotherapy?
abstract: BACKGROUND
  The Oncotype DX recurrence score (RS) assay has been validated for prediction of 10-year risk of distant recurrence and likelihood of benefit from chemotherapy in patients with estrogen receptor (ER)-positive, HER2-negative early breast cancer. Patients with high RS tumors have substantial benefit, and patients with low RS tumors have minimal if any benefit from chemotherapy. Tumor size is used as a key parameter when selecting patients for neoadjuvant chemotherapy. The aim of this study was to assess the distribution of RS in patients selected for neoadjuvant chemotherapy primarily according to tumor size.
  
  
  METHODS
  Patients with ER-positive and HER2-negative tumors that were node-negative or had no more than 1 positive node from three trials were included in this study. Oncotype DX was performed at Genomic Health, Inc., blinded to the clinical data. Descriptive statistics were calculated for distribution of RS for all cases.
  
  
  RESULTS
  Of 277 patients, 96 met eligibility criteria, and 81 had sufficient material for analysis. Median tumor size was 40 mm (interquartile range [IQR], 30-50 mm). Grade I, II, and III were observed in 13, 49, and 17 cases, respectively. There was a wide distribution of RS with a median of 21.4 (IQR, 16.05-26.75). In total, 23 (28.3%) had high, 28 (34.6%) intermediate, and 30 (37%) low RS results.
  
  
  CONCLUSIONS
  The RS may provide relevant information for neoadjuvant treatment decisions in select patients both in clinical practice and in studies. Inclusion of low RS disease patients in neoadjuvant trials will likely only dilute the ability to look at treatment effects.
authors: Departments of Medical Oncology, Gynecology, Pathology, and Statistics, University Hospital Jean Minjoz, Besançon, France; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France; INSERM, UMR1098, Besançon, France; EFS Bourgogne Franche-Comté, UMR1098, Besançon, France; Genomic Health, Inc., Redwood City, California, USA xavier.pivot@univ-fcomte.fr.
authors: Xavier
authors: X
authors: Pivot
authors: Departments of Medical Oncology, Gynecology, Pathology, and Statistics, University Hospital Jean Minjoz, Besançon, France; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France; INSERM, UMR1098, Besançon, France; EFS Bourgogne Franche-Comté, UMR1098, Besançon, France; Genomic Health, Inc., Redwood City, California, USA.
authors: Laura
authors: L
authors: Mansi
authors: Departments of Medical Oncology, Gynecology, Pathology, and Statistics, University Hospital Jean Minjoz, Besançon, France; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France; INSERM, UMR1098, Besançon, France; EFS Bourgogne Franche-Comté, UMR1098, Besançon, France; Genomic Health, Inc., Redwood City, California, USA.
authors: Loic
authors: L
authors: Chaigneau
authors: Departments of Medical Oncology, Gynecology, Pathology, and Statistics, University Hospital Jean Minjoz, Besançon, France; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France; INSERM, UMR1098, Besançon, France; EFS Bourgogne Franche-Comté, UMR1098, Besançon, France; Genomic Health, Inc., Redwood City, California, USA.
authors: Philippe
authors: P
authors: Montcuquet
authors: Departments of Medical Oncology, Gynecology, Pathology, and Statistics, University Hospital Jean Minjoz, Besançon, France; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France; INSERM, UMR1098, Besançon, France; EFS Bourgogne Franche-Comté, UMR1098, Besançon, France; Genomic Health, Inc., Redwood City, California, USA.
authors: Antoine
authors: A
authors: Thiery-Vuillemin
authors: Departments of Medical Oncology, Gynecology, Pathology, and Statistics, University Hospital Jean Minjoz, Besançon, France; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France; INSERM, UMR1098, Besançon, France; EFS Bourgogne Franche-Comté, UMR1098, Besançon, France; Genomic Health, Inc., Redwood City, California, USA.
authors: Fernando
authors: F
authors: Bazan
authors: Departments of Medical Oncology, Gynecology, Pathology, and Statistics, University Hospital Jean Minjoz, Besançon, France; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France; INSERM, UMR1098, Besançon, France; EFS Bourgogne Franche-Comté, UMR1098, Besançon, France; Genomic Health, Inc., Redwood City, California, USA.
authors: Erion
authors: E
authors: Dobi
authors: Departments of Medical Oncology, Gynecology, Pathology, and Statistics, University Hospital Jean Minjoz, Besançon, France; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France; INSERM, UMR1098, Besançon, France; EFS Bourgogne Franche-Comté, UMR1098, Besançon, France; Genomic Health, Inc., Redwood City, California, USA.
authors: Jean L
authors: JL
authors: Sautiere
authors: Departments of Medical Oncology, Gynecology, Pathology, and Statistics, University Hospital Jean Minjoz, Besançon, France; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France; INSERM, UMR1098, Besançon, France; EFS Bourgogne Franche-Comté, UMR1098, Besançon, France; Genomic Health, Inc., Redwood City, California, USA.
authors: Frederic
authors: F
authors: Rigenbach
authors: Departments of Medical Oncology, Gynecology, Pathology, and Statistics, University Hospital Jean Minjoz, Besançon, France; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France; INSERM, UMR1098, Besançon, France; EFS Bourgogne Franche-Comté, UMR1098, Besançon, France; Genomic Health, Inc., Redwood City, California, USA.
authors: Marie P
authors: MP
authors: Algros
authors: Departments of Medical Oncology, Gynecology, Pathology, and Statistics, University Hospital Jean Minjoz, Besançon, France; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France; INSERM, UMR1098, Besançon, France; EFS Bourgogne Franche-Comté, UMR1098, Besançon, France; Genomic Health, Inc., Redwood City, California, USA.
authors: Steve
authors: S
authors: Butler
authors: Departments of Medical Oncology, Gynecology, Pathology, and Statistics, University Hospital Jean Minjoz, Besançon, France; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France; INSERM, UMR1098, Besançon, France; EFS Bourgogne Franche-Comté, UMR1098, Besançon, France; Genomic Health, Inc., Redwood City, California, USA.
authors: Farid
authors: F
authors: Jamshidian
authors: Departments of Medical Oncology, Gynecology, Pathology, and Statistics, University Hospital Jean Minjoz, Besançon, France; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France; INSERM, UMR1098, Besançon, France; EFS Bourgogne Franche-Comté, UMR1098, Besançon, France; Genomic Health, Inc., Redwood City, California, USA.
authors: Phillip
authors: P
authors: Febbo
authors: Departments of Medical Oncology, Gynecology, Pathology, and Statistics, University Hospital Jean Minjoz, Besançon, France; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France; INSERM, UMR1098, Besançon, France; EFS Bourgogne Franche-Comté, UMR1098, Besançon, France; Genomic Health, Inc., Redwood City, California, USA.
authors: Christer
authors: C
authors: Svedman
authors: Departments of Medical Oncology, Gynecology, Pathology, and Statistics, University Hospital Jean Minjoz, Besançon, France; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France; INSERM, UMR1098, Besançon, France; EFS Bourgogne Franche-Comté, UMR1098, Besançon, France; Genomic Health, Inc., Redwood City, California, USA.
authors: Sophie
authors: S
authors: Paget-Bailly
authors: Departments of Medical Oncology, Gynecology, Pathology, and Statistics, University Hospital Jean Minjoz, Besançon, France; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France; INSERM, UMR1098, Besançon, France; EFS Bourgogne Franche-Comté, UMR1098, Besançon, France; Genomic Health, Inc., Redwood City, California, USA.
authors: Franck
authors: F
authors: Bonnetain
authors: Departments of Medical Oncology, Gynecology, Pathology, and Statistics, University Hospital Jean Minjoz, Besançon, France; University of Franche-Comté, UMR1098, SFR IBCT, Besançon, France; INSERM, UMR1098, Besançon, France; EFS Bourgogne Franche-Comté, UMR1098, Besançon, France; Genomic Health, Inc., Redwood City, California, USA.
authors: Christian
authors: C
authors: Villanueva
mesh_terms: D000328:Adult; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000188:drug therapy* / Q000235:genetics / Q000473:pathology*; D005260:Female; D020869:Gene Expression Profiling; D006801:Humans; D008875:Middle Aged; D020360:Neoadjuvant Therapy; D009364:Neoplasm Recurrence, Local / Q000235:genetics / Q000473:pathology*; D011446:Prospective Studies; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000378:metabolism; D011960:Receptors, Estrogen / Q000378:metabolism; D012307:Risk Factors; D016896:Treatment Outcome
chemical_list: D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; C508053:ERBB2 protein, human
keywords: Breast cancer; Neoadjuvant chemotherapy; Oncotype DX; Recurrence score