Level of Evidence (LoE) 1A for all gene expression assays in early ER+ HER2- breast cancer

We are pleased to share the latest insights from the ESMO Clinical Practice Guideline for the diagnosis, treatment, and follow-up of early breast cancer, particularly focusing on the significance of genomic testing in estrogen receptor-positive (ER+) and human epidermal growth factor receptor 2-negative (HER2-) early breast cancer.​

The guidelines underscore the pivotal role of genomic assays in informing treatment decisions for patients, especially in scenarios where there is uncertainty about the necessity of adjuvant chemotherapy. These assays provide valuable insights that can help tailor treatment strategies, potentially averting the administration of unnecessary chemotherapy for patients who are less likely to benefit from it.​

​Recommendation: The treatment strategy for each patient should be based on an individual risk–benefit analysis considering the tumour burden (size and location of the primary tumour, number of lesions and extent of LN involvement) and biology (pathology, including biomarkers and gene expression), as well as age, menopausal status, general health status and patient preferences [I, A].​

​We want to highlight the key changes that could impact your clinical decisions:

​No preferred genomic assay:​ The latest guidelines apply for all tests without any assay preference, confirming the recognition of robust study data for second generation options like EndoPredict^®. This acknowledgment solidifies its status as an advanced and cutting-edge solution that can be used in routine.​

​Same Level of Evidence for all assays:​ In the new guidelines first and second generation tests have the same Level of Evidence (LoE), which is 1A when used in the context of adjuvant setting. This recognition emphasizes the validity and effectiveness of advanced diagnostic tools like EndoPredict^®.​

​Inclusive approach to premenopausal patients: The guidelines embrace a more inclusive approach by avoiding general exclusions for premenopausal patients. This inclusive stance ensures that a broader spectrum of patients can benefit from the precision and accuracy offered by gene expression signatures like EndoPredict^®.​

​Mid-range data exclusion in chemotherapy decision table: Notably, the guidelines exclude RS scores falling between 16 and 25 from the chemotherapy decision table (Supplementary Table S5, description i). This underscores that mid-range data might not provide conclusive evidence and emphasizes the importance of clear risk distinctions. EndoPredict^® provides precise categorization into high and low-risk groups.​

“We are delighted to witness the latest guidelines recognizing the outstanding study data supporting EndoPredict^®, further solidifying its position as a reliable and advanced solution” said Apostolos Siscoglou, General Manager EU and LATAM at Myriad Genetics. “Our commitment to providing innovative solutions aligns seamlessly with the dynamic landscape of cancer care, ensuring that clinicians have the optimal resources to make well-informed decisions for the benefit of every breast cancer patient they serve.”​

For more information about EndoPredict^® and its impact on tailored treatment decisions, please check the white paper.

Reference: Loibl S. et al. Early breast cancer: ESMO Clinical Practice Guideline for diagnosis, treatment and follow-up. Annals of Oncology, 2024
Further details: Supplementary material: Supplementary Table S5. Overview of adjuvant therapy for HR-positive, HER2-negative EBC Stage.