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

Autor:	Lee HB; Department of Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.; Biomedical Research Institute, Seoul National University Hospital, Seoul, Republic of Korea.; Cancer Research Institute, Seoul National University, Seoul, Republic of Korea., Lee SB; Department of Surgery, Asan Medical Center, Seoul, Republic of Korea., Kim M; Bioinformatics Institute, Seoul National University, Seoul, Republic of Korea., Kwon S; Department of Electrical and Computer Engineering, Seoul National University, Seoul, Republic of Korea.; School of Biomedical Convergence Engineering, College of Information and Biomedical Engineering, Pusan National University, Yangsan, Republic of Korea., Jo J; Interdisciplinary Program in Bioinformatics, Seoul National University, Seoul, Republic of Korea., Kim J; Department of Pathology, Korea University Guro Hospital, Seoul, Republic of Korea., Lee HJ; Department of Pathology, Asan Medical Center, Seoul, Republic of Korea., Ryu HS; Department of Pathology, Seoul National University College of Medicine, Seoul, Republic of Korea., Lee JW; Department of Surgery, Asan Medical Center, Seoul, Republic of Korea., Kim C; Department of Pathology, Korea University Guro Hospital, Seoul, Republic of Korea., Jeong J; Celemics Inc., Seoul, Republic of Korea., Kim H; Celemics Inc., Seoul, Republic of Korea., Noh DY; Department of Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea.; Cancer Research Institute, Seoul National University, Seoul, Republic of Korea., Park IA; Department of Pathology, Seoul National University College of Medicine, Seoul, Republic of Korea., Ahn SH; Department of Surgery, Asan Medical Center, Seoul, Republic of Korea., Kim S; Bioinformatics Institute, Seoul National University, Seoul, Republic of Korea., Yoon S; Department of Electrical and Computer Engineering, Seoul National University, Seoul, Republic of Korea.; Interdisciplinary Program in Bioinformatics, Seoul National University, Seoul, Republic of Korea., Kim A; Department of Pathology, Korea University Guro Hospital, Seoul, Republic of Korea., Han W; Department of Surgery, Seoul National University College of Medicine, Seoul, Republic of Korea. hanw@snu.ac.kr.; Biomedical Research Institute, Seoul National University Hospital, Seoul, Republic of Korea.; Cancer Research Institute, Seoul National University, Seoul, Republic of Korea.
Jazyk:	angličtina
Zdroj:	Clinical cancer research : an official journal of the American Association for Cancer Research [Clin Cancer Res] 2020 Dec 15; Vol. 26 (24), pp. 6513-6522. Date of Electronic Publication: 2020 Oct 07.
DOI:	10.1158/1078-0432.CCR-20-2107
Abstrakt:	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 NGS-Prognostic 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 classified 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. (©2020 American Association for Cancer Research.)
Databáze:	MEDLINE
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