TEST:

RecurIndex®

In conclusion, this study will be the first prospective multicenter study to evaluate the risk-prediction value of RI testing in the Chinese population. Those findings will provide valuable evidence for the recommendation of RI testing for guiding adjuvant chemotherapy in early luminal breast cancer patients in China.

P=N/A; Research findings will be submitted for publication in peer-reviewed journals. NCT04069884.

The development and validation process of each tool was also briefly introduced. It is expected that the consensus will help guide and standardize the clinical use of multigene testing tools and further improve the level of precise treatment for EBC.

The present study highlights the unique features of HER2-low tumors in terms of their clinical characteristics as well as their gene expression profiles. HR status may influence the prognosis of patients with HER2-low expression, and patients with HR-positive/HER2-low expression may have a favorable outcome.

21-gene and PAM50 provide the good performance and show similar patterns in the prognosis of EBC; However, the DMFS rate of the high-risk in the Eastern population determined by 28-gene was much lower than 21-gene and PAM50, which means there are bigger chemo-benefit in the high-risk from 28-gene. In conclusion, 28-gene has better performance in the prognosis of the Eastern population and is a more suitable tool for Eastern breast cancer patients.

In this paper, we reviewed the 5 most widely used and studied genomic panel technologies in breast cancer, namely Oncotype DX, MammaPrint, RecurIndex, PAM50, and EndoPredict, according to accessibility and availability. Based on the results of the completed or ongoing clinical studies, we summarized the origin, applicable population, and clinical efficacy of each detection method, and discussed the potential development prospect of detection technology in the future.

HR-positive HER2-negative early breast cancer patients at low risk stratified by RecurIndex assay might be exempt from adjuvant chemotherapy. Whether adjuvant chemotherapy may derive survival benefits for high-risk patients still needs larger cohorts to verify.