EndoPredict® in early hormone receptor-positive, HER2-negative breast cancer
Katrin Almstedt, Susana Mendoza‐Elvira, M. Otto, Marco-Johannes Battista, Joscha Steetskamp, Anne-Sophie Heimes, Slavomir Krajnak, Alicia Poplawski, Aslihan Gerhold‐Ay, Annette Hasenburg, Carsten Denkert, Marcus Schmidt
Abstract
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 ( χ 2 -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 ® .