title: Impact of Oncotype DX breast Recurrence Score testing on adjuvant chemotherapy use in early breast cancer: Real world experience in Greater Manchester, UK.
abstract: BACKGROUND
  The National Institute for Health and Clinical Excellence (NICE) recommended the Oncotype DX®Breast Recurrence Score®(RS) assay as an option for informing adjuvant chemotherapy decisions in node-negative, oestrogen receptor (ER)+, human epidermal growth factor receptor 2 (HER2)-negative early breast cancer assessed to be at intermediate risk of recurrence based on clinicopathological factors. We evaluated the impact of RS testing on adjuvant chemotherapy decision-making in routine clinical practice in a UK Cancer Network.
  
  
  METHODS
  RS testing was performed in 201 females with newly diagnosed, ER+, HER2-negative, invasive breast cancer who underwent breast surgery with curative intent, were calculated to have a >3% overall survival benefit at 10 years from adjuvant chemotherapy based on PREDICT, and were considered for adjuvant chemotherapy. The impact of RS testing on adjuvant treatment decisions/associated cost was assessed.
  
  
  RESULTS
  In all patients, the multi-disciplinary team recommended chemotherapy but the RS result allowed 127/201 patients (63.2%) to avoid unnecessary adjuvant chemotherapy. Amongst ER+, HER2-negative, node-negative patients (eligible for Oncotype DX testing in UK guidelines), 60.3% were spared chemotherapy. In node-positive patients, the assay reduced the use of chemotherapy by 69.2%. The use of RS testing to guide treatment in these 201 patients was associated with significant cost saving (when considering the cost of RS testing for all patients plus chemotherapy and its associated cost for 74 patients).
  
  
  CONCLUSIONS
  Incorporating RS testing into routine clinical practice for selected node-negative and node-positive breast cancer patients significantly reduces the use of chemotherapy (p < 0.001) with its associated morbidity and costs.
authors.affiliation: The Christie Hospital, Department of Medical Oncology, 550 Wilmslow Rd, Manchester, M20 4BX, UK.
authors.forename: J
authors.initials: J
authors.lastname: Loncaster
authors.affiliation: The Christie Hospital, Department of Medical Oncology, 550 Wilmslow Rd, Manchester, M20 4BX, UK.
authors.forename: A
authors.initials: A
authors.lastname: Armstrong
authors.affiliation: The Christie Hospital, Department of Medical Oncology, 550 Wilmslow Rd, Manchester, M20 4BX, UK.
authors.forename: S
authors.initials: S
authors.lastname: Howell
authors.affiliation: The Christie Hospital, Department of Medical Oncology, 550 Wilmslow Rd, Manchester, M20 4BX, UK.
authors.forename: G
authors.initials: G
authors.lastname: Wilson
authors.affiliation: The Christie Hospital, Department of Medical Oncology, 550 Wilmslow Rd, Manchester, M20 4BX, UK; Bolton Hospital NHS Foundation Trust, Bolton Breast Unit, Minerva Rd, Farnworth, Bolton, BL4 0JR, UK.
authors.forename: R
authors.initials: R
authors.lastname: Welch
authors.affiliation: The Christie Hospital, Department of Medical Oncology, 550 Wilmslow Rd, Manchester, M20 4BX, UK.
authors.forename: A
authors.initials: A
authors.lastname: Chittalia
authors.affiliation: Ossian Health Economics and Communications, Bäumleingasse 20, 4051 Basel, Switzerland.
authors.forename: W J
authors.initials: WJ
authors.lastname: Valentine
authors.affiliation: Institute of Cancer Sciences, University of Manchester, Education and Research Centre, University Hospital of South Manchester, Southmoor Road, Wythenshawe, Manchester, M23 9LT, UK; University Hospital of South Manchester, Department of Surgery, Southmoor Road, Manchester, M23 9LT, UK. Electronic address: nigel.bundred@manchester.ac.uk.
authors.forename: N J
authors.initials: NJ
authors.lastname: Bundred
mesh_terms: D000328:Adult; D000368:Aged; D000970:Antineoplastic Agents / Q000191:economics / Q000627:therapeutic use*; D001943:Breast Neoplasms / Q000737:chemistry / Q000235:genetics* / Q000473:pathology / Q000628:therapy*; D017024:Chemotherapy, Adjuvant / Q000191:economics / Q000706:statistics & numerical data; D000066491:Clinical Decision-Making; D005260:Female; D005500:Follow-Up Studies; D020869:Gene Expression Profiling / Q000191:economics / Q000379:methods; D023281:Genomics; D006801:Humans; D008207:Lymphatic Metastasis; D008875:Middle Aged; D009361:Neoplasm Invasiveness; D017410:Practice Guidelines as Topic; D018719:Erb-b2 Receptor Tyrosine Kinases / Q000032:analysis; D011960:Receptors, Estrogen / Q000032:analysis; D015996:Survival Rate; D006113:United Kingdom; D055815:Young Adult
chemical_list: D000970:Antineoplastic Agents; D018719:Erb-b2 Receptor Tyrosine Kinases; D011960:Receptors, Estrogen; C508053:ERBB2 protein, human
keywords: Breast cancer; Chemotherapy; Evidence-based medicine; Molecular diagnostic testing; Prognosis