EndoPredict® in early hormone receptor-positive, HER2-negative breast cancer

K Almstedt ¹, S Mendoza ², M Otto ³, M J Battista ², J Steetskamp ², A S Heimes ², S Krajnak ², A Poplawski ⁴, A Gerhold-Ay ⁴, A Hasenburg ², C Denkert ⁵, M Schmidt ²

Affiliations

¹ Department of Obstetrics and Gynecology, University Medical Center Mainz, Langenbeckstr. 1, 55131, Mainz, Germany. katrin.almstedt@unimedizin-mainz.de.
² Department of Obstetrics and Gynecology, University Medical Center Mainz, Langenbeckstr. 1, 55131, Mainz, Germany.
³ Institute for Molecular Pathology, Trier, Germany.
⁴ Institute of Medical Biometry, Epidemiology and Informatics (IMBEI), University Medical Center Mainz, Mainz, Germany.
⁵ Institute of Pathology, Philipps-University Marburg and UKGM Marburg, Marburg, Germany.

PMID: 32436145
32 References

Abstract

Purpose: Evaluating consecutive early breast cancer patients, we analyzed both the impact of EndoPredict® on clinical decisions as well as clinico-pathological factors influencing the decision to perform this gene expression test.

Methods: Hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer patients treated between 2011 and 2016 were included in this study to investigate the role of EndoPredict® (EPclin) in the treatment of early breast cancer. A main study aim was to analyze the changes in therapy recommendations with and without EPclin. In addition, the impact of clinico-pathological parameters for the decision to perform EPclin was examined by Pearson's chi-squared test (χ2-test) and Fisher's exact test as well as univariate and multivariate logistic regressions.

Results: In a cohort of 869 consecutive early HR-positive, HER-negative breast cancer patients, EPclin was utilized in 156 (18.0%) patients. EPclin led to changes in therapy recommendations in 33.3% (n = 52), with both therapy escalation in 19.2% (n = 30) and de-escalation in 14.1% (n = 22). The clinico-pathological factors influencing the use of EPclin were age (P < 0.001, odds ratio [OR] 0.498), tumor size (P = 0.011, OR 0.071), nodal status (P = 0.021, OR 1.674), histological grade (P = 0.043, OR 0.432), and Ki-67 (P < 0.001, OR 3.599).

Conclusions: EPclin led to a change in therapy recommendations in one third of the patients. Clinico-pathological parameters such as younger age, smaller tumor size, positive nodal status, intermediate histological grade and intermediate Ki-67 had a significant influence on the use of EndoPredict®.

Keywords: Early breast cancer; EndoPredict®; Endocrine therapy; Gene expression; Prognosis; Treatment decision.

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References

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