A novel 95-gene signature (Curebest 95GC Breast) that predicts recurrence-risk in patients with ER-positive, HER2-negative, node-negative, early-stage primary invasive breast cancer with an intermediate Oncotype DX Recurrence Score.

Authors

null

Takeo Fujii

Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX

Takeo Fujii , Hiroko Masuda , Yee Chung Cheng , Fei Yang , Aysegul A. Sahin , Yasuto Naoi , Yuki Matsunaga , Akshara Singareeka Raghavendra , Arup Kumar Sinha , Jose R. Espinosa Fernandez , Anjali James , Keisuke Yamagishi , Debu Tripathy , Sachiyo Tada , Rubie S. Jackson , Shinzaburo Noguchi , Seigo Nakamura , Jared David Acoba , Naoto T. Ueno , Tomoko Matsushima

Organizations

Department of Breast Medical Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX, Univ of Texas MD Anderson Cancer Ctr, Houston, TX, Medical College of Wisconsin, Menomonee Falls, WI, The University of Texas MD Anderson Cancer Center, Houston, TX, Department of Breast and Endocrine Surgery, Osaka University, Osaka, Japan, Showa University, Tokyo, Japan, University of Southern California Norris Comprehensive Cancer Center, Los Angeles, CA, Sysmex Corporation, Kobe, Japan, The Rebecca Fortney Breast Center, Anne Arundel Medical Center, Annapolis, MD, Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, Osaka, Japan, Division of Breast Surgical Oncology, Department of Surgery, Showa University School of Medicine, Tokyo, Japan, University of Hawaii Cancer Center, Honolulu, HI, Morgan Welch Inflammatory Breast Cancer Research Program and Clinic, The University of Texas MD Anderson Cancer Center, Houston, TX, Central Research Laboratories, Sysmex Corporation, Kobe, Japan

Research Funding

Other

Background: The TAILORx trial demonstrated that adjuvant endocrine and chemoendocrine therapies had similar efficacy in patients with hormone receptor-positive, HER2-negative, node-negative breast cancer with an Oncotype DX recurrence score (RS) of 11-25. However, a predictive strategy is needed to identify patients with intermediate RS who may benefit from adjuvant chemoendocrine therapy. Curebest 95GC Breast (95GC) is a 95-gene signature that can stratify patients into two groups with high (95GC-H) and low (95GC-L) groups to predict the risk of recurrence. Our primary objective was to show that 95GC can classify patients with intermediate RS into binary recurrence risk groups. Methods: Patients with ER-positive, HER2-negative, node-negative invasive breast cancer and RS 11-30 who underwent definitive surgery and adjuvant endocrine therapy were included. RNA was derived from archived formalin-fixed, paraffin-embedded samples, and 95GC was calculated as reported previously. The Fisher exact and Brunner-Munzel tests were used to compare variables between 95GC groups. A Kaplan-Meier estimate with a log-rank test was used for recurrence-free survival (RFS) analysis. Results: The analysis included 178 patients from five institutions. The 5-year RFS rate in patients with RS 18-30 was higher in the 95GC-L group (n = 129, 96.3%) than in the 95GC-H group (n = 49, 90.9%; p = 0.002), which was consistent with results in an independent Japanese population (n = 224; p < 0.001). RFS rates significantly differed between the groups among patients with RS 11-25 as well (95GC-L, 97.4%; 95GC-H, 87.1%; p = 0.001). RFS rates did not differ between patients with RS 18-25 (94.8%) and those with RS 26-30 (93.8%; p = 0.33). Conclusions: 95GC can predict recurrence risk in patients with ER-positive, HER2-negative, node-negative invasive breast cancer and intermediate RS. Further prospective retrospective studies in the TAILORx population are warranted to confirm that 95GC can identify patients who may benefit from adjuvant chemoendocrine therapy.

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Abstract Details

Meeting

2019 ASCO Annual Meeting

Session Type

Poster Session

Session Title

Breast Cancer—Local/Regional/Adjuvant

Track

Breast Cancer

Sub Track

Adjuvant Therapy

Citation

J Clin Oncol 37, 2019 (suppl; abstr 542)

DOI

10.1200/JCO.2019.37.15_suppl.542

Abstract #

542

Poster Bd #

34

Abstract Disclosures