title: A prospective clinical utility and pharmacoeconomic study of the impact of the 21-gene Recurrence Score® assay in oestrogen receptor positive node negative breast cancer.
abstract: OBJECTIVE
  The primary purpose of this study was to measure the impact of the 21-gene Recurrence Score® result on systemic treatment recommendations and to perform a prospective health economic analysis in stage I-II, node-negative, oestrogen receptor positive (ER+) breast cancer.
  
  
  METHODS
  Consenting patients with ER+ node negative invasive breast cancer and their treating medial oncologists were asked to complete questionnaires about treatment preferences, level of confidence in those preferences and a decisional conflict scale (patients only) after a discussion of their diagnosis and risk without knowledge of the Recurrence Score. At a subsequent visit, the assay result and final treatment recommendations were discussed prior to both parties completing a second set of questionnaires. A Markov health state transition model was constructed, simulating the costs and outcomes experienced by a hypothetical 'assay naïve' population and an 'assay informed' population.
  
  
  RESULTS
  One hundred and fifty-six patients across two cancer centres were enrolled. Of the 150 for whom successful assay results were obtained, physicians changed their chemotherapy recommendations in 45 cases (30%; 95% confidence interval (CI) 22.8-38.0%); either to add (10%; 95% CI 5.7-16.0%) or omit (20%; 95% CI 13.9-27.3%) adjuvant chemotherapy. There was an overall significant improvement in physician confidence post-assay (p<0.001). Patient decisional conflict also significantly decreased following the assay (p<0.001). The simulation model found an incremental cost-effectiveness ratio of Canadian Dollars (CAD) $6630/quality-adjusted life years (QALY).
  
  
  CONCLUSIONS
  Within the context of a publicly funded health care system, the Recurrence Score assay significantly affects adjuvant treatment recommendations and is cost effective in ER+ node negative breast cancer.
authors.affiliation: Medical Oncology, British Columbia Cancer Agency (BCCA), Vancouver, Canada.
authors.forename: J A
authors.initials: JA
authors.lastname: Davidson
authors.affiliation: Canadian Centre for Applied Research in Cancer Control, British Columbia Cancer Research Centre, Vancouver, Canada.
authors.forename: I
authors.initials: I
authors.lastname: Cromwell
authors.affiliation: Medical Oncology, BCCA, Kelowna, Canada.
authors.forename: S L
authors.initials: SL
authors.lastname: Ellard
authors.affiliation: Medical Oncology, British Columbia Cancer Agency (BCCA), Vancouver, Canada.
authors.forename: C
authors.initials: C
authors.lastname: Lohrisch
authors.affiliation: Medical Oncology, British Columbia Cancer Agency (BCCA), Vancouver, Canada.
authors.forename: K A
authors.initials: KA
authors.lastname: Gelmon
authors.affiliation: Medical Oncology, British Columbia Cancer Agency (BCCA), Vancouver, Canada.
authors.forename: T
authors.initials: T
authors.lastname: Shenkier
authors.affiliation: Medical Oncology, British Columbia Cancer Agency (BCCA), Vancouver, Canada.
authors.forename: D
authors.initials: D
authors.lastname: Villa
authors.affiliation: Medical Oncology, British Columbia Cancer Agency (BCCA), Vancouver, Canada.
authors.forename: H
authors.initials: H
authors.lastname: Lim
authors.affiliation: Medical Oncology, British Columbia Cancer Agency (BCCA), Vancouver, Canada.
authors.forename: S
authors.initials: S
authors.lastname: Sun
authors.affiliation: Medical Oncology, BCCA, Kelowna, Canada.
authors.forename: S
authors.initials: S
authors.lastname: Taylor
authors.affiliation: Medical Oncology, BCCA, Kelowna, Canada.
authors.forename: M
authors.initials: M
authors.lastname: Taylor
authors.affiliation: Medical Oncology, BCCA, Kelowna, Canada.
authors.forename: B
authors.initials: B
authors.lastname: Czerkawski
authors.affiliation: Pathology, BCCA, Vancouver, Canada.
authors.forename: M
authors.initials: M
authors.lastname: Hayes
authors.affiliation: Pathology, BCCA, Vancouver, Canada.
authors.forename: D N
authors.initials: DN
authors.lastname: Ionescu
authors.affiliation: Genomic Health Inc., Redwood City, CA, USA.
authors.forename: C
authors.initials: C
authors.lastname: Yoshizawa
authors.affiliation: Genomic Health Inc., Redwood City, CA, USA.
authors.forename: C
authors.initials: C
authors.lastname: Chao
authors.affiliation: Canadian Centre for Applied Research in Cancer Control, British Columbia Cancer Research Centre, Vancouver, Canada; School of Population and Public Health, University of British Columbia, Vancouver, Canada.
authors.forename: S
authors.initials: S
authors.lastname: Peacock
authors.affiliation: Medical Oncology, British Columbia Cancer Agency (BCCA), Vancouver, Canada. Electronic address: schia@bccancer.bc.ca.
authors.forename: S K
authors.initials: SK
authors.lastname: Chia
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000188:drug therapy* / Q000191:economics / Q000235:genetics; D003362:Cost-Benefit Analysis; D017850:Economics, Pharmaceutical; D005260:Female; D006801:Humans; D008875:Middle Aged; D009367:Neoplasm Staging; D011446:Prospective Studies; D011960:Receptors, Estrogen / Q000096:biosynthesis*; D018570:Risk Assessment; D012307:Risk Factors; D059467:Transcriptome; D055815:Young Adult
chemical_list: D011960:Receptors, Estrogen