Use of Biomarkers and Multigene Assays in Breast Cancer

Lee S. Schwartzberg Presented by Lee S. Schwartzberg, MD, West Cancer Center, and Division of Hematology/Oncology, University of Tennessee Health Science Center, Memphis, Tennessee.

Search for other papers by Lee S. Schwartzberg in
Current site
Google Scholar
Restricted access

All patients with early breast cancer should be classified by subgroup through testing estrogen receptor, progesterone receptor, and HER2 status, with or without Ki-67 proliferation percentage. Genomic expression profiling aids clinical decision-making in most patients, because most are estrogen receptor–positive. The commercially available classifiers are prognostic for distant recurrence in node-negative and also node-positive patients. Patients at genomically low risk have excellent 5-year outcomes with endocrine therapy alone. Some assays also predict for benefit from adjuvant endocrine therapy and chemotherapy in node-negative and node-positive patients, but with varying levels of evidence. Genomic classifiers are also prognostic of late relapse and may predict benefit from extended adjuvant endocrine therapy.

Correspondence: Lee S. Schwartzberg, MD, West Cancer Center, 7945 Wolf River Boulevard, Memphis, TN 38138. E-mail:
  • Collapse
  • Expand
  • 1.

    Paik S, Shak S, Tang G et al.. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. N Engl J Med 2004;351:28172826.

  • 2.

    Van't Veer LJ, Dai H, van de Vijver MJ et al.. Gene expression profiling predicts clinical outcome of breast cancer. Nature 2002;415:530536.

  • 3.

    Sparano JA, Gray RJ, Makower DF et al.. Prospective validation of a 21-gene expression assay in breast cancer. N Engl J Med 2015;373:20052014.

  • 4.

    Paik S, Tang G, Shak S et al.. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol 2006;24:37263734.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 5.

    Cardoso F, van't Veer LJ, Bogaerts J et al.. 70-gene signature as an aid to treatment decisions in early-stage breast cancer. N Engl J Med 2016;375:717729.

  • 6.

    Petkov VI, Miller DP, Howlader N et al.. Breast-cancer-specific mortality in patients treated based on the 21-gene assay: a SEER population-based study. Available at: Accessed April 11, 2017.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 7.

    Albain KS, Barlow WE, Shak S et al.. Prognostic and predictive value of the 21-gene recurrence score assay in postmenopausal women with node-positive, oestrogen-receptor-positive breast cancer on chemotherapy: a retrospective analysis of a randomised trial. Lancet Oncol 2010;11:5565.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 8.

    Pan H, Gray RG, Davies C et al.. Predictors of recurrence during years 5-14 in 46,138 women with ER+ breast cancer allocated 5 years only of endocrine therapy (ET) [abstract]. J Clin Oncol 2016;34(Suppl):Abstract 505.

    • PubMed
    • Search Google Scholar
    • Export Citation
  • 9.

    Gradishar WJ, Anderson BO, Balassanian R et al.. NCCN Clinical Practice Guidelines in Oncology for Breast Cancer, Version 1.2017. Accessed April 5, 2017. To view the most recent version of these guidelines, visit

    • PubMed
    • Search Google Scholar
    • Export Citation
All Time Past Year Past 30 Days
Abstract Views 0 0 0
Full Text Views 742 318 11
PDF Downloads 305 69 16
EPUB Downloads 0 0 0