title: The impact of the 21-gene assay on adjuvant treatment decisions in oestrogen receptor-positive early breast cancer: a prospective study.
abstract: BACKGROUND
  International guidelines, including NICE, recommend using the 21-gene Recurrence Score assay for guiding adjuvant treatment decisions in ER+, HER2-negative early breast cancer (BC). We investigated the impact of adding this assay to standard pathological tests on clinicians'/patients' treatment decisions and on patients' decisional conflict in the United Kingdom.
  
  
  METHODS
  In this prospective multicentre study, eligibility criteria included: ER+ HER2-negative BC (N0/Nmic for patients ⩽50 years; ⩽3 positive lymph nodes for patients >50 years) and being fit for chemotherapy. Physicians'/patients' treatment choices and patients' decisional conflict were recorded pre- and post testing.
  
  
  RESULTS
  The analysis included 137 patients. Overall, adjuvant treatment recommendations changed in 40.7% of patients, with the direction of the change consistent with the Recurrence Score results (net decrease in chemotherapy recommendation rate in low Recurrence Score patients and net increase in high Recurrence Score patients). Patients' choices were generally consistent with physicians' recommendations. Post-testing, patients' decisional conflict decreased significantly (P<0.0001). In the 67 patients meeting the NICE criteria for testing, the recommendation change rate was 49.3%.
  
  
  CONCLUSIONS
  Recurrence Score testing significantly influenced treatment recommendations overall and in the subgroup of patients meeting the NICE criteria, suggesting that this test could substantially alter treatment patterns in the United Kingdom.
authors.affiliation: Bristol Cancer Institute, University Hospitals Bristol NHS Foundation Trust, Bristol BS2 8ED, UK.
authors.forename: Anna
authors.initials: A
authors.lastname: Kuchel
authors.affiliation: Bristol Cancer Institute, University Hospitals Bristol NHS Foundation Trust, Bristol BS2 8ED, UK.
authors.forename: Tim
authors.initials: T
authors.lastname: Robinson
authors.affiliation: Bristol Cancer Institute, University Hospitals Bristol NHS Foundation Trust, Bristol BS2 8ED, UK.
authors.forename: Charles
authors.initials: C
authors.lastname: Comins
authors.affiliation: Bristol Breast Care Centre, North Bristol NHS Trust, Bristol BS10 5NB, UK.
authors.forename: Mike
authors.initials: M
authors.lastname: Shere
authors.affiliation: The Beacon Centre, Musgrove Park Hospital, Taunton and Somerset NHS Foundation Trust, Taunton TA1 5DA, UK.
authors.forename: Mohini
authors.initials: M
authors.lastname: Varughese
authors.affiliation: Yeovil District Hospital NHS Foundation Trust, Yeovil BA21 4AT, UK.
authors.forename: Geoff
authors.initials: G
authors.lastname: Sparrow
authors.affiliation: Bristol Breast Care Centre, North Bristol NHS Trust, Bristol BS10 5NB, UK.
authors.forename: Ajay
authors.initials: A
authors.lastname: Sahu
authors.affiliation: Bristol Breast Care Centre, North Bristol NHS Trust, Bristol BS10 5NB, UK.
authors.forename: Louise
authors.initials: L
authors.lastname: Saunders
authors.affiliation: Bristol Cancer Institute, University Hospitals Bristol NHS Foundation Trust, Bristol BS2 8ED, UK.
authors.forename: Amit
authors.initials: A
authors.lastname: Bahl
authors.affiliation: Bristol Breast Care Centre, North Bristol NHS Trust, Bristol BS10 5NB, UK.
authors.forename: Simon J
authors.initials: SJ
authors.lastname: Cawthorn
authors.affiliation: Bristol Cancer Institute, University Hospitals Bristol NHS Foundation Trust, Bristol BS2 8ED, UK.
authors.forename: Jeremy P
authors.initials: JP
authors.lastname: Braybrooke
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000627:therapeutic use*; D014408:Biomarkers, Tumor / Q000235:genetics*; D001943:Breast Neoplasms / Q000188:drug therapy / Q000235:genetics* / Q000378:metabolism / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D003657:Decision Making; D003661:Decision Support Techniques; D005260:Female; D005500:Follow-Up Studies; D020869:Gene Expression Profiling; D006801:Humans; D008875:Middle Aged; D060787:Neoplasm Grading; D009361:Neoplasm Invasiveness; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy / Q000235:genetics* / Q000378:metabolism / Q000473:pathology; D009367:Neoplasm Staging; D010347:Patient Care Planning; D011379:Prognosis; D011446:Prospective Studies; D011960:Receptors, Estrogen / Q000378:metabolism*; D006113:United Kingdom
chemical_list: D014408:Biomarkers, Tumor; D011960:Receptors, Estrogen