Comparison of GenesWell BCT Score With Oncotype DX Recurrence Score for Risk Classification in Asian Women With Hormone Receptor-Positive, HER2-Negative Early Breast Cancer

Mi Jeong Kwon; Jeong Eon Lee; Joon Jeong; Sang Uk Woo; Jinil Han; Byeong-Il Kang; Jee-Eun Kim; Youngho Moon; Sae Byul Lee; Seonghoon Lee; Yoon-La Choi; Youngmi Kwon; Kyoung Song; Gyungyub Gong; Young Kee Shin

doi:10.3389/fonc.2019.00667

Comparison of GenesWell BCT Score With Oncotype DX Recurrence Score for Risk Classification in Asian Women With Hormone Receptor-Positive, HER2-Negative Early Breast Cancer

Front Oncol. 2019 Jul 24:9:667. doi: 10.3389/fonc.2019.00667. eCollection 2019.

Authors

Mi Jeong Kwon^{1

2}, Jeong Eon Lee^{3

4}, Joon Jeong⁵, Sang Uk Woo⁶, Jinil Han⁷, Byeong-Il Kang⁷, Jee-Eun Kim⁷, Youngho Moon⁷, Sae Byul Lee⁸, Seonghoon Lee⁶, Yoon-La Choi^{3

9

10}, Youngmi Kwon¹¹, Kyoung Song¹², Gyungyub Gong¹³, Young Kee Shin^{14

15}

Affiliations

¹ Department of Pharmacy, College of Pharmacy, Kyungpook National University, Daegu, South Korea.
² Research Institute of Pharmaceutical Sciences, Kyungpook National University, Daegu, South Korea.
³ Department of Health Sciences and Technology, Samsung Advanced Institute for Health Sciences and Technology (SAIHST), Sungkyunkwan University, Seoul, South Korea.
⁴ Department of Surgery, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
⁵ Department of Surgery, Gangnam Severance Hospital, Yonsei University College of Medicine, Seoul, South Korea.
⁶ Department of Surgery, Korea University Guro Hospital, Seoul, South Korea.
⁷ Gencurix, Inc., Seoul, South Korea.
⁸ Division of Breast Surgery, Department of Surgery, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
⁹ Laboratory of Cancer Genomics and Molecular Pathology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
¹⁰ Department of Pathology and Translational Genomics, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, South Korea.
¹¹ Center for Breast Cancer, National Cancer Center, Goyang-si, South Korea.
¹² LOGONE Bio Convergence Research Foundation, Seoul, South Korea.
¹³ Department of Pathology, Asan Medical Center, University of Ulsan College of Medicine, Seoul, South Korea.
¹⁴ Laboratory of Molecular Pathology and Cancer Genomics, College of Pharmacy, Seoul National University, Seoul, South Korea.
¹⁵ Department of Molecular Medicine and Biopharmaceutical Sciences, Graduate School of Convergence Science and Technology, Seoul National University, Seoul, South Korea.

Abstract

Introduction: The GenesWell Breast Cancer Test (BCT) is a recently developed multigene assay that predicts the risk of distant recurrence in patients with early breast cancer. Here, we analyzed the concordance of the BCT score with the Oncotype DX recurrence score (RS) for risk stratification in Asian patients with pN0-N1, hormone receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative breast cancer. Methods: Formalin-fixed, paraffin-embedded breast cancer tissues previously analyzed using the Oncotype DX test were assessed using the GenesWell BCT test. The risk stratification by the two tests was then compared. Results: A total of 771 patients from five institutions in Korea were analyzed. According to the BCT score, 527 (68.4%) patients were classified as low risk, and 244 (31.6%) as high risk. Meanwhile, 134 (17.4%), 516 (66.9%), and 121 (15.7%) patients were categorized into the low-, intermediate-, and high-risk groups, respectively, according to the RS ranges used in the TAILORx. The BCT high-risk group was significantly associated with advanced lymph node status, whereas no association between RS risk groups and nodal status was observed. The concordance between the two risk stratification methods in the overall population was 71.9% when the RS low-risk, and intermediate-risk groups were combined into one group. However, poor concordance was observed in patients aged ≤50 years and in those with lymph node-positive breast cancer. Conclusions: The concordance between the BCT score and RS was low in women aged ≤50 years or with lymph node-positive breast cancer. Further studies are necessary to identify more accurate tests for predicting prognosis and chemotherapy benefit in this subpopulation.

Keywords: Asian population; GenesWell BCT score; concordance; early breast cancer; oncotype DX recurrence score; risk classification.