21-Gene Recurrence Score (Oncotype Dx)

  • The 21-gene recurrence score assay:
    • Is a gene-expression assay:
      • That provides prognostic and predictive information:
        • In hormone receptor positive breast cancer
      • The 21-gene recurrence score:
        • Estimates the likelihood of distant recurrence in women with:
          • ER+ breast cancer with up to 3 lymph nodes positive
        • It also predicts who is more likely to benefit from adjuvant chemotherapy:
          • Patients with more than 3 lymph nodes:
            • Usually receive adjuvant chemotherapy and 21-gene signature assay is not routinely ordered
  • The recurrence score based on the 21-gene assay ranges from:
    • 0 to 100:
      • Is predictive of chemotherapy benefit:
        • When it is higher than 25
  • Both tamoxifen and aromatase inhibitors:
    • Have been shown to:
      • Reduce recurrence rates and improve survival in postmenopausal women
    • Although chemotherapy has been shown to be beneficial in many patient subsets:
      • The 21-gene recurrence score was developed:
        • To help ascertain which patients with:
          • ER-positive, node-negative breast cancer:
            • Would be most likely to benefit from chemotherapy in addition to adjuvant tamoxifen
    • In patients with an intermediate recurrence score:
      • The benefit of chemotherapy is unclear
  • The Trial Assigning IndividuaLized Options for Treatment (Rx) [TAILORx] trial:
    • Is a randomized prospective trial:
      • That randomized women with ER-positive breast cancer:
        • With a score of 11 to 25 to:
          • Chemotherapy plus endocrine therapy to endocrine therapy alone
      • This trial is closed to accrual, and the results of this trial for this cohort are pending:
        • However:
          • Outcomes data from a subset of 1626 patients with a recurrence score of less than 10:
            • Were recently published
        • These patients were assigned to:
          • Receive endocrine therapy alone without chemotherapy
        • This study reported a 5-year local recurrence rate of:
          • 0.5% in women with a recurrence score of:
            • Less than 10
        • Furthermore:
          • At 5 years:
            • The invasive disease free survival was:
              • 93.8%
            • The rate of freedom from recurrence of breast cancer at a distant site was:
              • 99.3%
            • At distant or local site was:
              • 98.7%
            • Overall survival rate of:
              • 98%
        • The authors concluded that a favorable gene expression profile:
          • Is associated with a very low rate of recurrence:
            • At 5 years with endocrine therapy alone
  • References:
    • Early Breast Cancer Trialists’ Collaborative Group (EBCTCG), Dowsett M, Forbes JF, et al. Aromatase inhibitors versus tamoxifen in early breast cancer: patient-level meta-analysis of the randomised trials. Lancet. 2015;386(10001):1341-1352.
    • 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(21):2005-2014.
    • Sparano JA et al, N Engl J Med 2018 Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF, et al. Adjuvant chemotherapy guided by a 21-gene expression assay in breast cancer. N Engl J Med 2018;379(2):111-121.
    • Paik S, Tang G, Shak S, Kim C, Baker J, Kim W, et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol; 2006;24(23):3726-3734.
    • Dowsett M, Cuzick J, Wale C, Forbes J, Mallon EA, Salter J, et al. Prediction of risk of distant recurrence using the 21-gene recurrence score in node-negative and node-positive postmenopausal patients with breast cancer treated with anastrozole or tamoxifen: a TransATAC study. J Clin Oncol. 2010;29(11):1829-1834.
    • Roberts MC, Miller DP, Shak S, Petkov VI. Breast cancer-specific survival in patients with lymph node-positive hormone receptor-positive invasive breast cancer and Oncotype DX Recurrence Score results in the SEER database. Breast Cancer Res Treat. 2017;163(2):303-310.

#Arrangoiz #CancerSurgeon #BreastSurgeon #BreastCancer #CASO #CenterforAdvancedSurgicalOncology

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