Recurrence Score® Result Impacts Treatment Decisions in Hormone Receptor-Positive, HER2-Negative Patients with Early Breast Cancer in a Real-World Setting—Results of the IRMA Trial

Abstract

Background: Patients with hormone receptor-positive (HR+), HER2-negative (HER2-) early breast cancer (eBC) with a high risk of relapse often undergo adjuvant chemotherapy. However, only a few patients will gain benefit from chemotherapy. Since classical tumor characteristics (grade, tumor size, lymph node involvement, and Ki67) are of limited value to predict chemotherapy efficacy, multigene expression assays such as the Oncotype DX® test were developed to reduce over- and undertreatment. The IRMA trial analyzed the impact of Recurrence Score® (RS) assessment on adjuvant treatment recommendations. Materials and methods: The RS result was assessed in patients with HR+/HER2− unilateral eBC with 0–3 pathologic lymph nodes who underwent primary surgical treatment at the Department for Women’s Health of Tuebingen University, Germany. Therapy recommendations without knowledge of the RS result were compared to therapy recommendations with awareness of the RS result. Results: In total, 245 patients underwent RS assessment. Without knowledge of the RS result, 92/245 patients (37.6%) would have been advised to receive chemotherapy. After RS assessment, 56/245 patients (22.9%) were advised to undergo chemotherapy. Chemotherapy was waived in 47/92 patients (51.1%) that were initially recommended to receive it. Chemotherapy was added in 11/153 patients (7.2%) that were recommended to not receive it initially. Summary: Using the RS result to guide adjuvant treatment decisions in HR+/HER2− breast cancer led to a substantial reduction of chemotherapy. In view of the results achieved in prospective studies, the RS result is among other risk-factors suitable for the individualization of adjuvant systemic therapy.

Which Patients Do We Need to Test for BRCA1/2 Mutation? Feasibility of Adjuvant Olaparib Treatment in Early Breast Cancer–Real-World Data from Two Large German Breast Centers

“…Albeit suffering from breast cancer with a high risk of relapse or disease progression, and therefore presenting with a clear indication for (neo)adjuvant chemotherapy, chemotherapy might have been omitted due to patient choice, age or comorbidities. Moreover, other prognostic factors like (dynamic) Ki67 and multigene expression arrays impact chemotherapy decisions in HR+/HER2− early breast cancer [14][15][16][17][18][19].…”

Detection of Disseminated Tumor Cells in Patients with Early Breast Cancer is Associated with 21-Gene-Assay: Results from the Impact of Recurrence Score ® Result on Adjuvant Treatment Decisions and Tumor Cell Dissemination in Estrogen Receptor-Positive and HER2-Negative Patients with Early Breast Cancer (IRMA) Trial

“…The IRMA trial previously was able to show that by using RS for decisions concerning adjuvant chemotherapy treatment could be further individualized, mostly reducing recommendations for adjuvant chemotherapy [19]. However, a smaller group of patients was identified who might benefit from chemotherapy according to RS, although it was not initially recommended to them [19].…”

“…In the Impact of Recurrence Score® (RS) result on adjuvant treatment decisions and tumor cell dissemination in ER-positive and HER2-negative patients with early breast cancer (IRMA) trial, RS result and DTC-status were assessed prospectively [19]. This trial already demonstrated that by adding RS results to clinicopathological risk factors in ER-positive/HER2-negative EBC, treatment recommendations could be individualized and over-or undertreatment with adjuvant chemotherapy prevented [19].…”

Association between 21-gene-assay and detection of disseminated tumor cells in patients with early breast cancer: results from the IRMA trial

“…In the I mpact of R ecurrence Score® (RS) result on adjuvant treatment decisions and tu m or cell dissemination in ER-positive and HER2-negative patients with e a rly breast cancer (IRMA) trial, RS result and DTC-status were assessed prospectively [ 19 ]. This trial already demonstrated that by adding RS results to clinicopathological risk factors in ER-positive/HER2-negative EBC, treatment recommendations could be individualized and over- or undertreatment with adjuvant chemotherapy prevented [ 19 ].…”