One of the main challenges in modern oncology is determining the optimal intensity of therapy in patients with early-stage breast cancer. The selection of a treatment plan significantly depends on the tumor’s molecular profile and stage; however, when managing patients with early-stage, hormone receptor-positive (HR+) and HER2-negative invasive carcinoma, clinicians often face a therapeutic dilemma regarding the need for personalized chemotherapy. To address this exact challenge, the U.S. Food and Drug Administration (FDA) has approved ArteraAI Breast, the first digital pathology-based risk stratification test entirely driven by artificial intelligence, created by the leading American healthcare technology company Artera. This innovative tool will assist clinicians in assessing the risk of metastasis and determining the need for chemotherapy in patients with early-stage hormone receptor-positive (HR+), HER2-negative invasive breast cancer.
The platform utilizes a multimodal artificial intelligence (MMAI) model trained on the clinical data of more than 8,500 patients. The system analyzes digitized histopathological slides obtained from surgical resection and clinical variables, based on which it classifies patients into low- and high-risk groups. Unlike traditional genomic tests, which often require lengthy laboratory processing, ArteraAI performs the analysis based on existing pathological material, making the process more efficient.
“As demonstrated by the FDA’s clinical validation, this artificial intelligence model can accurately predict the risk of metastasis and group patients into MMAI low- or MMAI high-risk groups according to the corresponding risk score. Patients with a low-risk profile have a significantly lower chance of cancer recurrence; therefore, they do not require the same intensity of treatment as patients with a high-risk profile. The results of the ArteraAI analysis, which includes a personalized AI risk score and associated MMAI risk groups, will help oncologists and patients in planning the right treatment and making decisions,” said Calvin Chao, MD, Vice President of Medical Sciences at the digital health company Artera.
Accurate risk stratification allows for the avoidance of both undertreatment and hypertherapy. Identifying patients with a low-risk profile (especially postmenopausal women with node-negative status) makes it possible to avoid excessive chemotherapy procedures and its side effects, such as neuropathy, reduced fertility, and infectious complications.
Although the technology demonstrates high prognostic accuracy, experts emphasize the need for additional clinical trials and reliable, peer-reviewed evidence. To implement ArteraAI Breast into clinical practice, prospective, direct clinical trial data are required to compare its efficacy against existing “gold standards,” such as Oncotype DX.
Source: medicalnewstoday.com
