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Development and Validation of a Next-Generation Sequencing-Based Multigene Assay to Predict the Prognosis of Estrogen Receptor-Positive, HER2-Negative Breast Cancer

Authors
Lee, Han-ByoelLee, Sae ByulKim, MinsuKwon, SunyoungJo, JeongheeKim, JinkyoungLee, Hee JinRyu, Han-SukLee, Jong WonKim, ChungyeulJeong, JaehwanKim, HyokiNoh, Dong-YoungPark, In-AeAhn, Sei-HyunKim, SunYoon, SungrohKim, AereeHan, Wonshik
Issue Date
15-12월-2020
Publisher
AMER ASSOC CANCER RESEARCH
Citation
CLINICAL CANCER RESEARCH, v.26, no.24, pp.6513 - 6522
Indexed
SCIE
SCOPUS
Journal Title
CLINICAL CANCER RESEARCH
Volume
26
Number
24
Start Page
6513
End Page
6522
URI
https://scholar.korea.ac.kr/handle/2021.sw.korea/50792
DOI
10.1158/1078-0432.CCR-20-2107
ISSN
1078-0432
Abstract
Purpose: Multigene assays provide useful prognostic information regarding hormone receptor (HR)-positive breast cancer. Next-generation sequencing (NGS)-based platforms have numerous advantages including reproducibility and adaptability in local laboratories. This study aimed to develop and validate an NGS-based multigene assay to predict the distant recurrence risk. Experimental Design: In total, 179 genes including 30 reference genes highly correlated with the 21-gene recurrence score (RS) algorithm were selected from public databases. Targeted RNA-sequencing was performed using 250 and 93 archived breast cancer samples with a known RS in the training and verification sets, respectively, to develop the algorithm and NGSPrognostic Score (NGS-PS). The assay was validated in 413 independent samples with long-term follow-up data on distant metastasis. Results: In the verification set, the NGS-PS and 21-gene RS displayed 91.4% concurrence (85/93 samples). In the validation cohort of 413 samples, area under the receiver operating characteristic curve plotted using NGS-PS values dassified for distant recurrence was 0.76. The best NGS-PS cut-off value predicting distant metastasis was 20. Furthermore, 269 and 144 patients were classified as low- and high-risk patients in accordance with the cut-off. Five- and 10-year estimates of distant metastasis-free survival (DMFS) for low- versus high-risk groups were 97.0% versus 77.8% and 93.2% versus 64.4%, respectively. The age-related HR for distant recurrence without chemotherapy was 9.73 (95% CI, 3.59-26.40) and 3.19 (95% CI, 1.40-7.29) for patients aged <= 50 and >50 years, respectively. Conclusions: The newly developed and validated NGS-based multigene assay can predict the distant recurrence risk in ER-positive, HER2-negative breast cancer.
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