Abstract
Most patients with early HR+ and HER2- breast cancer receive a hormone therapy; the clinical question still open is how to identify patients who can really benefit from adjuvant chemotherapy. The accurate identification of these patients is essential to avoid an over-treatment, increasing the risk of an unnecessary toxicity; on the contrary, the omission of chemotherapy can deprive high risk patients of a potential life-saving treatment (under-treatment). Several multigene assays (MGAs), assessing the risk of relapse according to the biological characteristics of the tumor, have been developed. To date, the 21-gene assay (Oncotype DX Breast Recurrence Score®) is the only test developed and validated to be actionable, i.e., able to predict the benefit of adjuvant chemotherapy. The different available tests can be classified according to their clinical utility based on their prognostic and predictive value. A prognostic test gives information about the outcome of the disease, regardless of the administered therapy. When the aim of the test is to drive the treatment decisions, the predictive component, and therefore the ability to accurately identify which patients could benefit from chemotherapy, is essential. This review summarizes the clinical evidences of the Oncotype DX® test supporting its clinical utility.
Highlights
Most patients with early hormonal receptor status (HR)+ and human epidermal growth factor 2 (HER2)− breast cancer receive a hormone therapy; the clinical question still open is how to identify patients who can really benefit from adjuvant chemotherapy
At 9 years, 84% of patients with Recurrence Score (RS) results 0–10 were invasive disease-free and 96.8% distant relapse-free (Figure 8) [28]. These results show that the use of the Oncotype DX test allows to identify the small number of patients who can substantially benefit from CT, saving most of them from toxicity and chronic side effects related to CT
Since many patients with a HR+, HER2- early breast cancer do not benefit from an adjuvant CT, there is a need to have a molecular rationale for identifying patients who can benefit from CT, as well those for whom CT would not add significant clinical benefit
Summary
Most patients with early HR+ and HER2− breast cancer receive a hormone therapy; the clinical question still open is how to identify patients who can really benefit from adjuvant chemotherapy. THE TREATMENT OF THE EARLY BREAST CANCER (EBC). The breast cancer represents 24% of all tumors and it is globally responsible for 15% of cancer death. Breast cancer is the most frequent cancer in women and the first cause of death for cancer in women. In Italy [1] 53.000 new cases of breast cancer have been estimated in 2019. The breast cancer is the most diagnosed cancer in women (30% of malignant tumours), with a different rate depending on age: 40% in patients aged 0–50 years; 35% in patients aged 50–69 years and 22% in patients aged >70 years
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