EndoPredict improves the prognostic classification derived from common clinical guidelines in ER-positive, HER2-negative early breast cancer

• Published in: Annals of oncology Vol. 24; no. 3; pp. 640 - 647
• Main Authors: Dubsky, P., Filipits, M., Jakesz, R., Rudas, M., Singer, C.F., Greil, R., Dietze, O., Luisser, I., Klug, E., Sedivy, R., Bachner, M., Mayr, D., Schmidt, M., Gehrmann, M.C., Petry, C., Weber, K.E., Kronenwett, R., Brase, J.C., Gnant, M.
• Format: Journal Article
• Language: English
• Published: Oxford Elsevier Ltd 01.03.2013; Oxford University Press
• Subjects: adjuvant treatment; Anastrozole; Antineoplastic agents; Antineoplastic Agents, Hormonal - administration & dosage; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Biological and medical sciences; breast cancer; Breast Neoplasms - classification; Breast Neoplasms - diagnosis; Breast Neoplasms - drug therapy; Breast Neoplasms - mortality; Chemotherapy, Adjuvant; Disease-Free Survival; endocrine therapy; EndoPredict gene; expression; Female; Gynecology. Andrology. Obstetrics; Humans; Kaplan-Meier Estimate; Mammary gland diseases; Medical sciences; Middle Aged; Nitriles - administration & dosage; Original; Pharmacology. Drug treatments; Practice Guidelines as Topic; Prognosis; Receptor, ErbB-2 - metabolism; Receptors, Estrogen - metabolism; Retrospective Studies; Risk Assessment; Tamoxifen - administration & dosage; Treatment Outcome; Triazoles - administration & dosage; Tumors; breast cancer; expression; adjuvant treatment; EndoPredict gene; endocrine therapy; Breast disease; Prognosis; Hormone therapy; Adjuvant treatment; erbB2 Gene; Breast cancer; Malignant tumor; Gene expression; Recommendation; Human Epidermal growth factor Receptor 2; Mammary gland diseases; C-Onc gene; Classification; Genetics; Early; Protooncogene; Cancer
• ISSN: 0923-7534; 1569-8041
• DOI: 10.1093/annonc/mds334

In early estrogen receptor (ER)-positive/HER2-negative breast cancer, the decision to administer chemotherapy is largely based on prognostic criteria. The combined molecular/clinical EndoPredict test (EPclin) has been validated to accurately assess prognosis in this population. In this study, the clinical relevance of EPclin in relation to well-established clinical guidelines is assessed. We assigned risk groups to 1702 ER-positive/HER2-negative postmenopausal women from two large phase III trials treated only with endocrine therapy. Prognosis was assigned according to National Comprehensive Cancer Center Network-, German S3-, St Gallen guidelines and the EPclin. Prognostic groups were compared using the Kaplan–Meier survival analysis. After 10 years, absolute risk reductions (ARR) between the high- and low-risk groups ranged from 6.9% to 11.2% if assigned according to guidelines. It was at 18.7% for EPclin. EPclin reassigned 58%–61% of women classified as high-/intermediate-risk (according to clinical guidelines) to low risk. Women reclassified to low risk showed a 5% rate of distant metastasis at 10 years. The EPclin score is able to predict favorable prognosis in a majority of patients that clinical guidelines would assign to intermediate or high risk. EPclin may reduce the indications for chemotherapy in ER-positive postmenopausal women with a limited number of clinical risk factors.