A 95-gene signature stratifies recurrence risk of invasive disease in ER-positive, HER2-negative, node-negative breast cancer with intermediate 21-gene signature recurrence scores

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

Research output: Contribution to journalArticlepeer-review

Abstract

Purpose: A subset of patients with intermediate 21-gene signature assay recurrence score may benefit from adjuvant chemoendocrine therapy, but a predictive strategy is needed to identify such patients. The 95-gene signature assay was tested to stratify patients with intermediate RS into high (95GC-H) and low (95GC-L) groups that were associated with invasive recurrence risk. Methods: Patients with ER-positive, HER2-negative, node-negative breast cancer and RS 11–25 who underwent definitive surgery and adjuvant endocrine therapy without any cytotoxic agents were included. RNA was extracted from archived formalin-fixed, paraffin-embedded samples, and 95-gene signature was calculated. Results: 206 patients had RS of 11–25 (95GC-L, N = 163; 95GC-H, N = 43). In Cox proportional hazards model, 95GC-H was significantly associated with shorter time to recurrence than was 95GC-L (HR 5.94; 95%CI 1.81–19.53; P = 0.005). The correlation between 95-gene signature and 21-gene signature assay scores was not strong (correlation coefficient r = 0.27), which might suggest that 95-gene signature reflects biological characteristics differing from what 21-gene signature shows. Conclusions: The 95-gene signature stratifies patients with ER-positive, HER2-negative, node-negative invasive breast cancer and intermediate RS of 11–25 into high and low groups that are associated with recurrence risk of invasive disease. Further retrospective analysis in the prospectively accrued TAILORx population is warranted to confirm that 95-gene signature can identify patients who would benefit from adjuvant chemoendocrine therapy.

Original languageEnglish (US)
Pages (from-to)455-461
Number of pages7
JournalBreast Cancer Research and Treatment
Volume189
Issue number2
DOIs
StatePublished - Sep 2021

Keywords

  • 21-gene signature assay
  • 95-gene signature assay
  • Breast cancer
  • Estrogen receptor-positive
  • Recurrence Score

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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