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DOI: 10.1055/s-0040-1717835
EndoPredict® in early hormone receptor-positive, HER2-negative breast cancer: Impact on clinical decisions and clinico-pathological factors influencing its application
Purpose This study analyzed not only the impact on clinical decisions but also assessed clinico-pathological factors influencing the decision to perform this gene expression test.
Methods The retrospective study included hormone receptor (HR)-positive and human epidermal growth factor receptor 2 (HER2)-negative early breast cancer patients treated between 2011 and 2016. EndoPredict® (EPclin) used RNA from formalin-fixed and paraffin-embedded (FFPE) breast cancer tissue in combination with tumor size and nodal status. The impact of clinico-pathological parameters on 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 analysis. In addition, changes in therapy recommendations with and without EPclin were analyzed.
Results In a cohort of 869 consecutive early HR-positive, HER2-negative breast cancer cases, EPclin was used in 156 (18.0 %) patients. EPclin led to changes in therapy recommendations in 33.3 % (n = 52) with therapy escalation in 19.2 % (n = 30) and de-escalation in 14.1 % (n = 22).The clinico-pathological factors independently influencing the use of EPclin were younger age (OR 1.919, P = 0.001), tumor size (pT1 OR 13.990, P = 0.011; pT2 OR 11.883, P = 0.017), negative nodal status (OR 1.741, P = 0.012) histological grade (G1 OR 2.466, P = 0.029; G2 OR 2.660, P< 0.001), intermediate Ki-67 (OR 3.875, P = 0.008) and an intermediate St. Gallen risk category (35.878, P = 0.001).
Conclusions Clinico-pathological parameters like younger age, smaller tumor size, negative nodal status, low/intermediate histological grade and intermediate Ki-67 had a significant influence on use of EndoPredict®. EPclin led to a change in therapy recommendations in one third of the patients.
Publication History
Article published online:
07 October 2020
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