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Jpn J Clin Oncol. 2019 Jul 9. pii: hyz102. doi: 10.1093/jjco/hyz102. [Epub ahead of print]

A preliminary report of head-to-head comparison of 18-gene-based clinical-genomic model and oncotype DX 21-gene assay for predicting recurrence of early-stage breast cancer.

Author information

1
Department of Medicine, MacKay Medical College, New Taipei, Taiwan.
2
Department of General Surgery, MacKay Memorial Hospital, Taipei, Taiwan.
3
Department of Pathology, National Taiwan University Hospital, Taipei, Taiwan.
4
Department of Hematology Oncology, Koo Foundation Sun Yat-Sen Cancer Center, Taipei, Taiwan.
5
Department of Surgery, National Taiwan University Hospital, Taipei, Taiwan.
6
Department of Research and Product Development, Amwise Diagnostics Pte. Ltd., Singapore.
7
Department of Surgery, Koo Foundation Sun Yat-Sen Cancer Center, Taipei, Taiwan.
8
Department of Radiation Oncology, Koo Foundation Sun Yat-Sen Cancer Center, Taipei, Taiwan.

Abstract

BACKGROUND:

The information of Oncotype DX applied in Asian breast cancer patients is limited. A recurrence index for distant recurrence (RI-DR) has been developed for early-stage breast cancer (EBC) from tumor samples in Chinese patients. In this study, we compared the prognostic performance of the Oncotype DX (ODx) recurrence score (RS) with the RI-DR for any recurrence risk type.

MATERIALS AND METHODS:

One hundred thirty-eight (138) patients with hormone receptor-positive and human epidermal growth factor receptor 2-negative EBC who were previously tested with ODx were included for testing with the RI-DR. The cutoff score to partition the low- and high-risk patients was 26 for RS and 36 for RI-DR. The primary endpoint was recurrence-free survival (RFS).

RESULTS:

The concordance between the RI-DR and RS was 83% in N0 patients and 81% in node-positive patients when the RS score cutoff was set at 26. With a median follow-up interval of 36.8 months, the 4-year RFS for the high- and low-risk groups categorized by the RS were 61.9% and 95.0%, respectively (hazard ratio: 10.6, 95.0% confidence interval [CI]: 1.8-62.9). The 4-year RFS in the high- and low-risk groups categorized by the RI-DR were 72.6% and 98.5%, respectively (hazard ratio: 18.9, 95% CI: 1.8-138.8).

CONCLUSION:

This paper illustrated the performance of RI-DR and ODx RS in breast cancer women in Taiwan. There was high concordance between the RI-DR and RS. The RI-DR is not inferior to the RS in predicting RFS in EBC patients. This study will fill the gap between the current and best practice in Chinese patients.

KEYWORDS:

NanoString; breast cancer; distant recurrence; gene-expression profiling; prognosis

PMID:
31287883
DOI:
10.1093/jjco/hyz102

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