Clinical use of the Oncotype DX genomic test to guide treatment decisions for patients with invasive breast cancer

Abstract

Implementation of the Oncotype DX assay has led to a change in the manner in which chemotherapy is utilized in patients with early stage, estrogen receptor (ER)-positive, node-negative breast cancer; ensuring that patients at highest risk of recurrence are prescribed systemic treatment, while at the same time sparing low-risk patients potential adverse events from therapy unlikely to influence their survival. This test generates a recurrence score between 0 and 100, which correlates with probability of distant disease recurrence. Patients with low-risk recurrence scores (0–17) are unlikely to derive significant survival benefit with adjuvant chemotherapy and hormonal agents derived from using adjuvant hormonal therapy only. Conversely, adjuvant chemotherapy has been shown to significantly improve survival in patients with high-risk recurrence scores (≥31). Trials are ongoing to determine how best to manage patients with recurrence scores in the intermediate range. This review outlines the introduction and impact of Oncotype DX testing on practice; ongoing clinical trials investigating its utility; and challenging clinical scenarios where the absolute recurrence score may require careful interpretation. We also performed a bibliometric analysis of publications on the topics of breast cancer and Oncotype DX as a surrogate marker of acceptability and incorporation of the assay into the management of patients with breast cancer.

Relationship Between Hereditary Cancer Syndromes and Oncotype DX Recurrence Score

“…9,10 Those with a high RS have a significant reduction in rates of distant recurrence when treated with sequential chemotherapy and endocrine therapy; those with low RS show no significant difference in rates of distant recurrence when treated with endocrine therapy only versus endocrine therapy and chemotherapy. [11][12][13][14][15][16][17] ODX has been validated for prognosis and prediction of chemotherapy benefit in sporadic breast cancers both retrospectively and prospectively, most recently in the TAILORx study. 18 This study found that adjuvant endocrine therapy and chemoendocrine therapy had similar efficacy in hormone receptorepositive, HER2-negative breast cancer in patients with a midrange ODX RS of 11 to 25.…”

MetaGxData: Clinically Annotated Breast, Ovarian and Pancreatic Cancer Datasets and their Use in Generating a Multi-Cancer Gene Signature

“…In breast cancer, the signature was benchmarked against the clinically relevant mammaprint and oncotype DX signatures. [41][42][43] Our three gene (ER, HER2, and AURKA) subtype classification model (SCM) was chosen to classify patients into the ER+/HER2-, ER-/HER2-, and HER2+ subtypes 35 . The MetaGx signature was highly prognostic in the analysis using all patients (HR 1.60, n = 1,971) ( Fig.…”

Triple-Negative Breast Cancer: A Review of Conventional and Advanced Therapeutic Strategies

“…and (C) immunohistopathological examinations [4]. Employing all these tools, the clinical oncologist can stage the disease using TNM classification [5] and reviewing the guidelines established in rigorous clinical trials, although, they can also use genetic profiling tests such as MammaPrint [6] and Oncotype DX [7] to understand disease prognosis better.…”

“…(3) HER-2 (human epidermal growth factor receptor-2); (4) EGFR (epidermal growth factor receptor) 45%-70% of Triple-negative breast cancer (TNBC) patients show this biomarker [9]; (5) CK5/6; (6) VEGF (vascular endothelial growth factor); (7) KI67.…”