title: Prospective cost-effectiveness analysis of genomic profiling in breast cancer.
abstract: BACKGROUND
  The cost-effectiveness of the 70-gene signature (70-GS) (MammaPrint®) has earlier been estimated using retrospective validation data. Based on the prospective 5-year survival data of the microarRAy-prognoSTics-in-breast-cancER (RASTER) study, the aim here was to evaluate the cost-effectiveness reflecting the actual use in clinical practice, including reality-based compliance rates.
  
  
  METHODS
  Costs and outcomes (quality-adjusted-life-years (QALYs)) were calculated in node-negative (N-) patients included in the RASTER study (n=427). Sensitivity and specificity of the 70-gene and Adjuvant! Online (AO) were based on 5-year distant-disease-free survival (DDFS). Subgroup analyses were performed for two groups for whom benefit of the 70-gene had earlier been reported: (1) ductal, oestrogen receptor-positive (ER+), tumour diameter 10-30 mm, grade II, age 40-70; (2) ductal, oestrogen receptor-positive, tumour diameter 5-30 mm, grade II/III and age 40-70.
  
  
  RESULTS
  Based on 5-year survival data, the cost-effectiveness of the 70-gene signature versus AO was prospectively confirmed. The total health care costs per patient were €26,786 for the 70-gene and €29,187 for AO. The quality adjusted life years yielded 12.49 and 11.88, respectively. The subgroups retrieved slightly higher life gains and higher costs, but all resulted finally in a favourable position for the 70-gene signature.
  
  
  CONCLUSIONS
  The use of the 70-gene signature, as judged appropriate by doctors and patients and supported by a low risk 70-gene signature as an oncological safe choice, was also found to be cost-effective.
authors.affiliation: Netherlands Cancer Institute (NKI-AVL), Department of Psychosocial Research and Epidemiology, Amsterdam, The Netherlands.
authors.forename: V P
authors.initials: VP
authors.lastname: Retèl
authors.forename: M A
authors.initials: MA
authors.lastname: Joore
authors.forename: C A
authors.initials: CA
authors.lastname: Drukker
authors.forename: J M
authors.initials: JM
authors.lastname: Bueno-de-Mesquita
authors.forename: M
authors.initials: M
authors.lastname: Knauer
authors.forename: H
authors.initials: H
authors.lastname: van Tinteren
authors.forename: S C
authors.initials: SC
authors.lastname: Linn
authors.forename: W H
authors.initials: WH
authors.lastname: van Harten
mesh_terms: D000328:Adult; D000368:Aged; D001943:Breast Neoplasms / Q000175:diagnosis / Q000188:drug therapy* / Q000235:genetics*; D017024:Chemotherapy, Adjuvant / Q000191:economics; D003362:Cost-Benefit Analysis; D005260:Female; D020869:Gene Expression Profiling; D015972:Gene Expression Regulation, Neoplastic; D006801:Humans; D008390:Markov Chains; D008875:Middle Aged; D020411:Oligonucleotide Array Sequence Analysis / Q000191:economics; D017063:Outcome Assessment, Health Care / Q000191:economics; D011379:Prognosis; D011446:Prospective Studies; D019057:Quality-Adjusted Life Years; D011960:Receptors, Estrogen / Q000378:metabolism; D018570:Risk Assessment / Q000191:economics; D016019:Survival Analysis; D013997:Time Factors; D047368:Tumor Burden / Q000187:drug effects
chemical_list: D011960:Receptors, Estrogen
keywords: Adjuvant systemic treatment; Breast cancer; Gene expression profiling; Real world cost-effectiveness