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Breast cancer is the most common malignant tumor in women. With the development of genomics technology and medical frontier technology, the systemic treatment of breast cancer has gradually entered the era of personalized medicine. However, the decision-making of adjuvant radiotherapy for breast cancer still mainly relies on traditional clinicopathological factors, and there is a lack of scientific and reliable tools to guide precise radiotherapy in different populations. Hormone receptor (HR) positive/human epidermal growth factor receptor 2 (HER2) negative breast cancer is the most common molecular subtype of breast cancer. The 21-Gene recurrence score (RS) test (Oncotype Dx™, Genomic Health, Redwood City, CA) is a commercially available genomic test for breast cancer. In this article, we reviewed the current research evidence on the use of 21-Gene RS test for radiotherapy decision-making in HR-positive HER2-negative early breast cancer. Current clinical studies support the predictive value of 21-Gene RS test for adjuvant radiotherapy, and several large-scale prospective clinical studies in this area are underway.

In the past decade, with the introduction of precision medicine, the treatment of breast cancer has entered a new era. It now tends towards the de-escalation and individualization of treatment plans, aiming to minimize iatrogenic toxicity while maximizing benefits for patients without compromising survival outcomes. The 21-gene assay evaluates the expression levels of 21 genes associated with breast cancer recurrence and provides a 21-gene recurrence score (RS) to assess the risk of recurrence and potential benefit from chemotherapy in breast cancer patients. Currently, RS is recommended by multiple guidelines such as the American Society of Clinical Oncology (ASCO), National Comprehensive Cancer Network (NCCN), and Chinese Anti-Cancer Association(CACA) for guiding adjuvant therapy in hormone receptor-positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-) early-stage breast cancer patients. However, there are still controversies surrounding its clinical application. Current research mainly focuses on optimizing RS to accurately identify patients who would benefit from adjuvant therapy, thus enabling more personalized treatment plans for breast cancer patients. This review provides an overview of the 21-gene assay, its application in HR+ breast cancer patients' adjuvant therapy, its impact on clinical decision-making, existing controversies regarding RS, and prospects for integrating RS with clinical pathological information. The aim is to guide further expansion of RS's application in clinical practice and achieve more precise adjuvant therapy for breast cancer patients.

Objective To investigate the postoperative adjuvant therapeutic decision-oriented role of 21-gene recurrence score (RS) in hormone receptor positive and lymph node negative early stage breast cancer. Methods Our study included 110 hormone receptor positive and lymph node negative early stage breast cancer patients who were tested for 21-gene RS and underwent surgical treatment between June 2013 and December 2016 at The First Affiliated Hospital of Xi'an Jiaotong University. According to the 21-gene RS, the included patients were divided into low-, intermediate- and high-risk groups. We compared the changes of treatment decisions before and after the 21-gene test. Results Before taking the 21-gene test, 61 patients (55%) were recommended both adjuvant chemotherapy and endocrine therapy. However, after taking the test, 32 patients (29%) were treated with only adjuvant endocrine therapy (McNemar's test, P <0.001). Among them, in the low-risk and intermediate risk groups, 24 patients (39%) and 8 patients (20%) were respectively treated with only adjuvant endocrine therapy instead of adjuvant chemotherapy combined with endocrine therapy (McNemar's test, P<0.001; P=0.008) after taking the 21-gene test. Conclusion For patients with hormone receptor positive and lymph node negative early stage breast cancer, taking the 21-gene test can significantly avoid excessive postoperative adjuvant chemotherapy in both low- and intermediate-risk groups. Moreover, it can reduce the postoperative chemotherapy rate and lessen the side effects of chemotherapy. [ABSTRACT FROM AUTHOR]

Objective To investigate the effect of 21-gene recurrence score on adjuvant chemotherapy decisions for patients with estrogen receptor (ER)-positive, epidermal growth factor receptor 2 (HER-2)-negative and lymph node (LN)-negative early stage-breast cancer. Methods One hundred and forty-eight patients with ER+ , HER-2- and LN- early stage breast cancer were recruited in the Ruijin hospital, Shanghai Jiao Tong University School of Medicine. The 21-gene recurrence score (RS)assay was performed and systemic therapeutic decisions were made before and after knowing the RS results under multidisciplinary discussion. The effects of RS assay and the other influential factors on adjuvant chemotherapy decision were further analyzed. Results After knowing the RS results, treatment decisions were changed in 26 out of 148 patients(17.6%). Among them, 9 out of 26 patients were not recommended for chemotherapy; 16 of 26 had treatment recommendation changed to chemotherapy, and chemotherapy regimen was changed in the last one patient. Multivariate analysis showed that RS, age and histological grade were independent factors of decision-making for adjuvant chemotherapy. Conclusion Our results suggest that 21-gene recurrence score significantly influences decision making for adjuvant chemotherapy in patients with ER+ , HER-2- and LN- early stage breast cancer. [ABSTRACT FROM AUTHOR]

Objective: To investigate the effect of 21-gene recurrence score on adjuvant chemotherapy decisions for patients with estrogen receptor (ER)-positive, epidermal growth factor receptor 2 (HER-2)-negative and lymph node (LN)-negative early stage-breast cancer. Methods: One hundred and forty-eight patients with ER+ , HER-2- and LN- early stage breast cancer were recruited in the Ruijin hospital, Shanghai Jiao Tong University School of Medicine. The 21-gene recurrence score (RS)assay was performed and systemic therapeutic decisions were made before and after knowing the RS results under multidisciplinary discussion. The effects of RS assay and the other influential factors on adjuvant chemotherapy decision were further analyzed. Results: After knowing the RS results, treatment decisions were changed in 26 out of 148 patients(17.6%). Among them, 9 out of 26 patients were not recommended for chemotherapy; 16 of 26 had treatment recommendation changed to chemotherapy, and chemotherapy regimen was changed in the last one patient. Multivariate analysis showed that RS, age and histological grade were independent factors of decision-making for adjuvant chemotherapy. Conclusion: Our results suggest that 21-gene recurrence score significantly influences decision making for adjuvant chemotherapy in patients with ER+ , HER-2- and LN- early stage breast cancer.