Abstract

This retrospective study evaluated the impact of intermediate Recurrence Score® results on adjuvant treatment decisions in estrogen receptor-positive (ER+) early invasive breast cancer, comparing treatment recommendations pre-testing with actual treatments received post-testing. Of the 111 patients included in the analysis, 78 (70.3%) had hormonal therapy (HT) and 33 (29.7%) had chemohormonal therapy (CHT) recommendations pre-testing. The Recurrence Score was significantly higher in those with a pre-testing CHT recommendation compared with those with a pre-testing HT recommendation (median of 24 vs. 22; P = 0.047; Mann–Whitney–Wilcoxon [MWW] test). Post-testing, treatment of 24 patients (21.6%) was different from their pre-testing recommendation. The difference between CHT recommendation rate pre-testing and the rate of CHT received post-testing was nonsignificant for the entire cohort and for patients’ subgroups (by age, tumor size, and grade) (P >0.17; McNemar’s test). Following classification of the cohort into two Recurrence Score subcategories (low-intermediate, [18-25]; high-intermediate, [26-30]), changes in treatment decisions (pre-testing recommendations vs. actual treatments received post testing) were reported for 16.5% of low-intermediate and 34.4% of high-intermediate patients. Post-testing, the rate of CHT decreased (by 58%) in the low-intermediate subcategory and increased (by 64%) in the high-intermediate subcategory (P <0.01, both subcategories). In logistic regression analyses, the Recurrence Score subcategory was the only significant predictor of changes in treatment decisions (pre-testing recommendations vs. actual treatments received post testing; P <0.01). The only significant difference between the two subsets of patients with such a change (HT to CHT, 11 patients; CHT to HT, 13 patients) was the Recurrence Score (median of 28 vs. 20, respectively; P = 0.0014; MWW test). These findings demonstrate that intermediate Recurrence Score results provide clinically relevant information and impact treatment decisions in ER + early breast cancer.

Highlights

  • To assess the impact of the clinicopathologic parameters and the Recurrence Score results on treatment changes, we modeled the probability of a change between treatment recommendation and actual treatment received as a function of age (≤50, >50 years), tumor size (≤15 mm, >15 mm), grade (1, 2, and 3), and the Recurrence Score subcategory for patients with pre-testing hormonal therapy recommendations and for patients with pre-testing chemohormonal therapy recommendations

  • Oncotype DX testing is routinely used in clinical practice in Israel to support clinical decision making for patients with ER + early invasive breast cancer

  • The current analysis focused on the impact of intermediate Recurrence Score results on adjuvant treatment decisions in ER + early invasive breast cancer in real-life clinical practice and demonstrated that intermediate results led to a change between pre-testing recommendations and actual treatments received in approximately one-fifth (21.6%) of the cohort

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Summary

Introduction

The Oncotype DXW Breast Cancer assay (Genomic Health, Inc., Redwood City, CA) has been validated as a prognosticator and a predictor of the likelihood of chemotherapy benefit in estrogen receptor-positive (ER+) early invasive breast cancer (Paik et al 2004; Paik et al 2006; Habel et al 2006; Goldstein et al 2008; Albain et al 2010; Dowsett et al 2010; Toi et al 2010; Mamounas et al 2012). In the intermediate Recurrence Score category, the observed changes in treatment recommendations were not consistent across studies, and data on the impact of the Recurrence Score and clinicopathologic characteristics on treatment recommendations in this subpopulation are limited (Oratz et al 2007; Klang et al 2010; Lo et al 2010; Ademuyiwa et al 2011; Geffen et al 2011; Oratz et al 2011; Albanell et al 2012; Eiermann et al 2012; Gligorov et al 2012; Albanell et al 2013; Holt et al 2013). The current study was designed to evaluate the associations between Recurrence Score results and clinicopathologic characteristics in a cohort of patients with ER + early invasive breast cancer and an intermediate Recurrence Score result and to evaluate the impact of the Recurrence Score results and clinicopathologic characteristics on treatment decisions

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