Diagnostics (Nov 2022)

Prognostic Comparison between Oncotype DX<sup>®</sup> and a 23-Gene Classifier, RecurIndex<sup>®</sup>, on the Taiwan Breast Cancer Population

  • Chuan-Hsun Chang,
  • Po-Sheng Yang,
  • Chia-Ming Hsieh,
  • Ting-Hao Chen,
  • Skye Hung-Chun Cheng,
  • Cheng-En Yang,
  • Chiun-Sheng Huang

DOI
https://doi.org/10.3390/diagnostics12112850
Journal volume & issue
Vol. 12, no. 11
p. 2850

Abstract

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The applicability of the Oncotype DX® (Genomic Health, Inc., Redwood City, CA, USA) recurrence score (RS) in Asian populations is unclear. A 23-gene classifier, RecurIndex® (Amwise Diagnostics, Pte. Ltd., Singapore), has been developed based on the gene expression profiles of early-stage breast cancer patients of ethnic Han Chinese population in Taiwan. This study aimed to compare the performance of the Oncotype DX® RS with the RecurIndex® recurrence index (RI) for predicting relapse-free survival. Therefore, we calculated both the RI and RS for 110 early stage breast cancer patients, with the cut-off value for high-risk recurrence set at 26 and 29 for the RS and the RI, respectively. With relapse-free interval (RFI) as the primary endpoint, the concordance between RS and RI was 78.2% (Kappa value = 0.297). For a median follow-up interval of 27 months, there was a statistically significant difference in RFI between the high- and low-risk groups defined by the RI (p = 0.04) but not between risk groups defined by the RS (p = 0.66). In conclusion, whereas there was high concordance between the RecurIndex® RI and the Oncotype DX RS, the current data showed that the RI had a better discrimination for recurrence risk than the RS. Subsequent studies with larger sample sizes will be needed to confirm the superiority of the RI over the RS in the Asian population.

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