Prognostic value of the 21-gene recurrence score in ER-positive, HER2-negative, node-positive breast cancer was similar in node-negative diseases: a single-center study of 800 patients

Abstract

Multi-gene assays have emerged as crucial tools for risk stratification in early-stage breast cancer. This study aimed to evaluate the prognostic significance of the 21-gene recurrence score (RS) in Chinese patients with pN0-1, estrogen receptor-positive (ER⁺), human epidermal growth factor receptor 2-negative (HER2^–) breast cancer. Among 800 patients recruited between 2009 and 2016, the median RS was 24 (0–69), with 27.4%, 46.8%, and 25.9% patients classified into low-, intermediate-, and high-risk groups. Cox regression analysis demonstrated that the high-risk category was associated with significantly higher odds of invasive disease-free survival (IDFS) and distant disease-free survival (DDFS) events compared with the low-risk category (IDFS: HR= 2.450, 95% CI 1.017–5.902, P= 0.046; DDFS: HR= 2.829, 95% CI 1.013–7.901, P= 0.047). No significant association between RS category and overall survival (OS) was found (intermediate vs. low: HR= 1.244, 95% CI 0.292–5.297, P= 0.768; high vs. low: HR= 2.933, 95% CI 0.759–11.327, P= 0.119). RS, as a continuous variable, was a highly significant predictor for IDFS (HR= 1.028, 95% CI 1.010–1.047, P= 0.002), DDFS (HR= 1.030, 95% CI 1.010–1.051, P= 0.003), and OS (HR= 1.034, 95% CI 1.007–1.063, P= 0.014). Our findings suggested that RS may predict IDFS in Chinese patients with ER⁺/HER2^– breast cancer with N0 or N1 disease.

Keywords

early breast cancer / 21-gene assay / recurrence score / prognosis

References

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Acknowledgements

The authors wish to thank Dr. Lin Lin, Dr. Xiaochun Fei, Dr. Jin Hong, Dr. Yan Fang, Dr. Wei Cao, and Dr. Caijin Lin for their invaluable assistance in this study. This work was supported by grants from the Technology Innovation Act Plan of Shanghai Municipal Science and Technology Commission (Nos. 14411950200 and 14411950201), the National Natural Science Foundation of China (No. 81772797), and the Shanghai Municipal Commission of Health and Family Planning (No. 201840323). The funders had no role in the study design, data collection and analysis, decision to publish, or preparation of the manuscript.

Compliance with ethics guidelines

Jiayi Wu, Weiqi Gao, Xiaosong Chen, Chunxiao Fei, Lin Lin, Weiguo Chen, Ou Huang, Siji Zhu, Jianrong He, Yafen Li, Li Zhu, and Kunwei Shen declare no conflicts of interest in this work. All procedures followed were in accordance with the ethical standards of the responsible committee on human experimentation (institutional and national) and with the Helsinki Declaration of 1975, as revised in 2000 (5). Informed consent was obtained from all patients for being included in the study. Our study concerned patient’s tumor samples, clinical and pathological characteristics, adjuvant treatment, and the following data. Tumor samples and the following data were collected with written informed consent from patients. The treatment recommendations of the enrolled patients were not affected by the results of this study.

Electronic Supplementary Material

Supplementary material is available in the online version of this article at https://doi.org/10.1007/s11684-020-0738-0 and is accessible for authorized users.

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