21-Gene Recurrence Score and Survival Outcomes in the Phase III Multicenter TAILORx Clinical Trial
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Background: Recurrence score (RS) based on a 21-gene genomic assay is frequently used to estimate risk of distant recurrence for choice of adjuvant chemotherapy in breast cancer. It remains unclear whether RS is an independent prognostic factor for breast cancer–specific survival (BCSS) and overall survival (OS) in the TAILORx trial population. Methods: We evaluated the association of RS with BCSS and OS plus recurrence-free interval (RFI) and invasive disease–free survival (DFS) using multivariable Cox proportional hazards regression analysis, adjusting for clinicopathologic measures, in 8,916 patients with hormone receptor–positive, HER2-negative, node-negative breast cancer. Likelihood ratio (LR) test was used to assess the relative amount of prognostic information provided by RS to BCSS, OS, RFI, and DFS, comparatively. Results: Event rates for BCSS, OS, RFI, and DFS were 1.7%, 5.2%, 5.6%, and 12.6%, respectively, by up to 11.6 years of follow-up. Compared with low-range RS (0–10), patients with midrange (11–25) and high-range (26–100) RS had inferior BCSS (adjusted hazard ratio [aHR], 5.12 [95% CI, 2.09–16.92] and 8.03 [95% CI, 2.91–28.47], respectively) and RFI (aHR, 1.68 [95% CI, 1.23–2.36] and 3.05 [95% CI, 2.02–4.67], respectively), independent of clinicopathologic factors. High-range score was associated with an increased risk of DFS (aHR, 1.56 [95% CI, 1.20–2.04]) but not significantly associated with OS (aHR, 1.44 [95% CI, 0.95–2.18]). Midrange score was associated with neither DFS (aHR, 1.15 [95% CI, 0.96–1.38]) nor OS (HR 1.14 [95% CI, 0.87–1.52]). LR-χ2 values were 83.0 and 65.1 for RFI and BCSS, respectively, and 17.5 and 33.6 for OS and DFS, respectively (P<.0001). Conclusions: RS is an independent measure for BCSS and recurrence prognoses relative to OS in early-stage breast cancer. It carries more prognostic information for breast cancer–specific outcomes.
Submitted May 1, 2023; final revision received October 18, 2023; accepted for publication January 16, 2024. Published online July 17, 2024.
Author contributions: Study concept and design: Yang. Data analysis and interpretation: All authors. Manuscript preparation: All authors.
Data availability statement: The TAILORx trial Dataset NCT00310180-D1 can be obtained from the National Clinical Trials Network (NCTN) Data Archive of the National Cancer Institute (NCI) after approval. Further inquiries can be directed to the corresponding author.
Disclosures: The authors have disclosed that they have not received any financial consideration from any person or organization to support the preparation, analysis, results, or discussion of this article.
Funding: This study was supported in part by the Cancer Diagnosis Program, Division of Cancer Treatment and Diagnosis at the National Cancer Institute of the National Institutes of Health (S.X. Yang).
Disclaimer: The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The manuscript was prepared using the Dataset NCT00310180-D1 from the National Clinical Trials Network (NCTN) Data Archive of the National Cancer Institute (NCI). Data were originally collected from clinical trial NCT00310180: Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. All analyses and conclusions in this manuscript are the sole responsibility of the authors and do not necessarily reflect the opinions or views of the clinical trial investigators, the NCTN, or the NCI.
Supplementary material: Supplementary material associated with this article is available online at https://doi.org/10.6004/jnccn.2024.7008. The supplementary material has been supplied by the author(s) and appears in its originally submitted form. It has not been edited or vetted by JNCCN. All contents and opinions are solely those of the author. Any comments or questions related to the supplementary materials should be directed to the corresponding author.
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