Implementation of Risk-Stratified Breast Cancer Prevention With a Polygenic Risk Score Test in Clinical Practice.

Background: Breast cancer (BC) screening with mammography reduces mortality but considers currently only age as a risk factor. Personalized risk-based screening has been proposed as a more efficient alternative. For that, risk prediction tools are necessary. Genome-wide association studies have iden...

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Published in:Breast Cancer: Basic & Clinical Research pp. 1 - 14
Main Authors: Padrik, Peeter, Puustusmaa, Mikk, Tõnisson, Neeme, Kolk, Berit, Saar, Regina, Padrik, Anna, Tasa, Tõnis
Format: equations & formulas research tables/charts Journal Article
Published: Sage Publications Inc. 10/12/2023
Online Access:View this record in EBSCOhost
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      jtl: Breast Cancer: Basic & Clinical Research
      issn: 11782234
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    pubinfo:
      dt: 10/12/2023
      pid: 344
      pub: Sage Publications Inc.
      place: Thousand Oaks, California
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        10.1177/11782234231205700
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        atl: Implementation of Risk-Stratified Breast Cancer Prevention With a Polygenic Risk Score Test in Clinical Practice.
      aug:
        au:
          Padrik, Peeter
          Puustusmaa, Mikk
          Tõnisson, Neeme
          Kolk, Berit
          Saar, Regina
          Padrik, Anna
          Tasa, Tõnis
        affil: OÜ Antegenes, Tartu, Estonia
      sug:
        subj:
          Breast Neoplasms Diagnosis
          Breast Neoplasms Prevention and Control
          Cancer Screening Methods
          Risk Assessment
          Polymorphism, Single Nucleotide
          Medical Practice
          Program Implementation
          Human
          Female
          Retrospective Design
          Prediction Models
          Cox Proportional Hazards Model
          Regression
          Descriptive Statistics
          Female
      ab: Background: Breast cancer (BC) screening with mammography reduces mortality but considers currently only age as a risk factor. Personalized risk-based screening has been proposed as a more efficient alternative. For that, risk prediction tools are necessary. Genome-wide association studies have identified numerous genetic variants (single-nucleotide polymorphisms [SNPs]) associated with BC. The effects of SNPs are combined into a polygenic risk score (PRS) as a risk prediction tool. Objectives: We aimed to develop a clinical-grade PRS test suitable for BC risk-stratified screening with clinical recommendations and implementation in clinical practice. Design and methods: In the first phase of our study, we gathered previously published PRS models for predicting BC risk from the literature and validated them using the Estonian Biobank and UK Biobank data sets. We selected the best performing model based on prevalent data and independently validated it in both incident data sets. We then conducted absolute risk simulations, developed risk-based recommendations, and implemented the PRS test in clinical practice. In the second phase, we carried out a retrospective analysis of the PRS test's performance results in clinical practice. Results: The best performing PRS included 2803 SNPs. The C-index of the Cox regression model associating BC status with PRS was 0.656 (SE = 0.05) with a hazard ratio of 1.66. The PRS can stratify individuals with more than a 3-fold risk increase. A total of 2637 BC PRS tests have been performed for women between the ages 30 and 83. Results in clinical use overlap well with expected PRS performance with 5.7% of women with more than 2-fold and 1.4% with more than 3-fold higher risk than the population average. Conclusion: The PRS test separates different BC risk levels and is feasible to implement in clinical practice.
      pubtype: Academic Journal
      doctype:
        equations & formulas
        research
        tables/charts
        Journal Article
      ougenre: Article
    language: English
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