Previous studies have confirmed that 70 gene expression profiling tests (Mammaprint) can improve the prediction of the clinical prognosis of patients with early breast cancer. This study aims to provide evidence to support the clinical application of these 70 gene expression profiles in patients who choose adjuvant chemotherapy.
In this randomized phase 3 study, the researchers recruited 6,693 women with early-stage breast cancer, the genomic risk of these women (using 70 gene expression profiles) and clinical risk (using the online version of the adjuvant). I have decided. Women with lower clinical and genomic risk did not receive chemotherapy, while women with higher clinical and genomic risk received chemotherapy. In patients with inconsistent results between the two risks, genomic or clinical risk is used to determine the use of chemotherapy. The main research goal is to evaluate the 95% confidence interval for the 5-year survival rate of patients with low-risk gene expression profiles and high-risk clinical features that have not received chemotherapy without distant metastasis.
As a result, 1550 (23.2%) patients were identified as high clinical risk and low genomic risk. Within 5 years, the survival rate of patients in this group who did not receive chemotherapy without distant metastasis was 94.7% (96.2CI, 92.5%-95%). The absolute difference in survival between these patients and those receiving chemotherapy is 1.5%, and the survival rate without chemotherapy is low. The subgroup of patients with estrogen receptor positive, human epithelial growth factor receptor 2 negative, or lymph node negative or lymph node positive showed similar survival rates without distant metastasis. In summary, according to 70 gene expression profiles, the 5-year survival rate of early-stage breast cancer patients with higher clinical recurrence risk and low genomic risk is 1.5% lower than that of chemotherapy without distant metastatic chemotherapy. become. Based on these findings, approximately 46% of women with high clinical risk of breast cancer may not need chemotherapy.