Abstract

BackgroundThe benefits of postoperative chemotherapy in patients with estrogen receptor (ER)-positive breast cancer remain unclear. The use of tumor grade, Ki-67, or ER expression failed to provide an accurate prognosis of the risk of relapse after surgery in patients. This study aimed to evaluate whether a multigene assay Curebest™ 95GC Breast (95GC) can identify the risk of recurrence and provide more insights into the requirements for chemotherapy in patients.MethodsThis single-arm retrospective multicenter joint study included patients with ER-positive, node-negative breast cancer who were treated at five facilities in Japan and had received endocrine therapy alone as adjuvant therapy. The primary lesion specimens obtained during surgery were analyzed using the 95GC breast cancer multigene assay. Based on the 95GC results, patients were classified into low-risk (95GC-L) and high-risk (95GC-H) groups.ResultsThe 10-year relapse-free survival rates were 88.4 and 59.6% for the 95GC-L and 95GC-H groups, respectively. Histologic grade, Ki-67, and PAM50 exhibited a significant relationship with the 95GC results. The segregation into 95GC-L and 95GC-H groups within established clinical factors can identify subgroups of patients using histologic grade or PAM50 classification with good prognosis without receiving chemotherapy.ConclusionsBased on the results of our retrospective study, 95GC could be used to evaluate the long-term prognosis of ER-positive, node-negative breast cancer. Even though further prospective validation is necessary, the inclusion of 95GC in clinical practice could help to select optimal treatments for breast cancer patients and identify those who do not benefit from the addition of chemotherapy, thus avoiding unnecessary treatment.

Highlights

  • The benefits of postoperative chemotherapy in patients with estrogen receptor (ER)-positive breast cancer remain unclear

  • Samples for which CurebestTM 95GC Breast (95GC) assessment results could not be obtained owing to problems with RNA quality were excluded, and 75 patients were selected for analysis

  • Histologic grade, Ki-67, and PAM50 exhibited a significant relationship with the 95GC result as evaluated by Fisher’s exact test

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Summary

Introduction

The benefits of postoperative chemotherapy in patients with estrogen receptor (ER)-positive breast cancer remain unclear. The use of tumor grade, Ki-67, or ER expression failed to provide an accurate prognosis of the risk of relapse after surgery in patients. The overall survival and prevention of relapse after surgery are improving owing to the increase in the number of available treatment options. 10–20% of patients experience relapse after surgery [2, 3], and chemotherapy improves breast cancer survival, its benefits in ER-positive breast cancers are being questioned lately [4]. The risk of breast cancer relapse was assessed by taking into account the patient’s age, tumor diameter, tumor grade, Ki-67, and ER expression. The risk of relapse and the need for chemotherapy are difficult to predict accurately based solely on clinicopathological factors

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