title: Impact of a 21-gene RT-PCR assay on treatment decisions in early-stage breast cancer: an economic analysis based on prognostic and predictive validation studies.
abstract: BACKGROUND
  The prognostic accuracy for distant recurrence-free survival using a 21-gene reverse-transcriptase polymerase chain reaction (RT-PCR) assay underwent validation in 668 lymph node-negative, estrogen receptor-positive women with early-stage breast cancer receiving tamoxifen on National Surgical Adjuvant Breast Program (NSABP) B-14. The predictive accuracy for treatment efficacy also underwent validation in 651 patients randomized on NSABP B-20 and 645 patients on NSABP B-14.
  
  
  METHODS
  Patients were classified as high (recurrence score [RS] >or= 31), intermediate (RS 18-30), or low (RS < 18) risk for distant recurrence at 10 years. Cost-effectiveness ratios were estimated for RS-guided treatment compared with either tamoxifen alone or the combined chemotherapy and tamoxifen.
  
  
  RESULTS
  Distant recurrence was reported in RS low-risk, intermediate-risk, and high-risk patients at 10 years in 3.7%, 17.8%, and 38.3% receiving tamoxifen alone and 5.0%, 10.1%, and 11.1% receiving the chemotherapy and tamoxifen. RS-guided therapy is associated with a gain in individual life expectancy of 2.2 years compared with tamoxifen alone, whereas it is associated with similar life expectancy to that seen with the chemotherapy and tamoxifen strategy. RS-guided therapy is estimated to provide a net cost savings of $2256 compared with chemotherapy and tamoxifen with an incremental cost-effectiveness ratio of $1944 per life year saved compared with tamoxifen alone.
  
  
  CONCLUSIONS
  Treatment decisions based on RS-guided therapy compared with tamoxifen alone are associated with greater efficacy with acceptable cost-effectiveness ratios, and associated with similar efficacy and lower cost compared with chemotherapy and tamoxifen for patients with lymph node-negative, estrogen receptor-positive early-stage breast cancer.
authors.affiliation: Department of Medicine, James P. Wilmot Cancer Center, University of Rochester, Rochester, New York 14642, USA. Gary_Lyman@urmc.rochester.edu
authors.forename: Gary H
authors.initials: GH
authors.lastname: Lyman
authors.forename: Leon E
authors.initials: LE
authors.lastname: Cosler
authors.forename: Nicole M
authors.initials: NM
authors.lastname: Kuderer
authors.forename: John
authors.initials: J
authors.lastname: Hornberger
mesh_terms: D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D001943:Breast Neoplasms / Q000175:diagnosis* / Q000188:drug therapy* / Q000473:pathology; D017024:Chemotherapy, Adjuvant; D003362:Cost-Benefit Analysis; D018572:Disease-Free Survival; D005260:Female; D015870:Gene Expression; D006801:Humans; D008198:Lymph Nodes / Q000473:pathology; D009010:Monte Carlo Method; D009364:Neoplasm Recurrence, Local / Q000175:diagnosis* / Q000473:pathology; D011379:Prognosis; D012333:RNA, Messenger / Q000032:analysis; D020133:Reverse Transcriptase Polymerase Chain Reaction / Q000191:economics / Q000379:methods*; D013629:Tamoxifen / Q000627:therapeutic use; D016896:Treatment Outcome
chemical_list: D018931:Antineoplastic Agents, Hormonal; D012333:RNA, Messenger; D013629:Tamoxifen