What does this research mean for the field?

The 21-gene Recurrence Score remains prognostic in node-positive breast cancer patients, with real-world outcomes mirroring those of the RxPONDER trial. Novelty: ClaimNovelty.CONFIRMATORY. Consensus alignment: ConsensusAlignment.SUPPORTS_CONSENSUS.

What question did this study set out to answer?

This study aims to assess the real-world utility of the 21-gene Recurrence Score in managing node-positive breast cancer patients.

February 19, 2026

Abstract PS5-05-25: Is the 21-Gene Recurrence Score Validated for Real-World use in Node Positive Breast Cancer? A Retrospective Cohort Study

Key Points

This study aims to assess the real-world utility of the 21-gene Recurrence Score in managing node-positive breast cancer patients.
Conducted a retrospective cohort study using prospectively collected data.
Included hormone receptor-positive, HER2-negative patients with 1-3 positive lymph nodes.
Utilized hospital records to extract treatment and survival data.
Included statistical analyses such as Kaplan-Meier curves and Cox regression tests.
282 patients were analyzed.
High 21-gene Recurrence Scores (>25) correlated with worse outcomes (HR 6.59).
Endocrine therapy adherence was the strongest predictor of survival (HR 0.012).
Chemotherapy provided limited benefit for postmenopausal patients and some benefit for premenopausal patients.

Abstract

Abstract 1Kalinsky K et al. RxPONDER (SWOG S1007), RS ≤25, HR+/HER2−, node+ BC. Cancer Res. 2023;83(5 Suppl):GS1-01 Background: The 21-gene Recurrence Score is a validated prognostic and predictive tool for breast cancer, with evidence supporting its utility over a 9-year follow-up. The RxPONDER1 trial further confirmed its clinical relevance in a controlled setting. However, its performance in real-world clinical practice remains underexplored. This study evaluates the application of the 21-gene Recurrence Score in routine care using RxPONDER1 criteria and determines whether its prognostic value remains in real-world data. Methods: We conducted a retrospective cohort study using prospectively collected data from Node-positive patients at the Norfolk and Norwich University, a tertiary referral cancer centre treating 650 breast cancer patients per year (2015-2024). Eligible patients were hormone receptor-positive, HER2-negative breast cancer patients with 1-3 positive lymph nodes and available 21-gene Recurrence Scores. Treatment and survival data were extracted from hospital records. Patients were stratified by menopausal status and recurrence score. Kaplan-Meier curves and Cox regression analyses assessed outcomes and compared with RxPONDER1 findings. Results: 282 patients were included. Chemotherapy was administered to all high-risk premenopausal patients (24.1%) and selectively to intermediate-risk patients based on additional clinical factors. In post-menopausal patients (75.9%), chemotherapy was primarily reserved for high-risk cases. High 21-gene Recurrence Scores (25) were significantly associated with poorer outcomes (HR 6.59, 95% CI 1.39-31.15, p = 0.017), intermediate scores (11-25) showed a non-significant trend (HR 2.38, p = 0.265). Endocrine therapy adherence was the strongest independent predictor of survival (HR 0.012, p = 0.004). Chemotherapy plus endocrine therapy (CET) showed no statistically significant benefit after adjustment (HR 1.82, p = 0.5) These findings align with RxPONDER1: chemotherapy showed no significant benefit in postmenopausal patients, but some benefit in premenopausal patients. Conclusions: The 21-gene Recurrence Score remains prognostic in node-positive patients and real-world outcomes mirror RxPONDER1 findings. Our study highlights the importance of endocrine therapy adherence and supports continued use of the 21-gene Recurrence Score for guiding chemotherapy decisions in clinical practice. Larger cohort real-world studies are needed to further validate these findings. Citation Format: R. Rodgerson, M. Youssef. Is the 21-Gene Recurrence Score Validated for Real-World use in Node Positive Breast Cancer? A Retrospective Cohort Study abstract. In: Proceedings of the San Antonio Breast Cancer Symposium 2025; 2025 Dec 9-12; San Antonio, TX. Philadelphia (PA): AACR; Clin Cancer Res 2026;32(4 Suppl):Abstract nr PS5-05-25.

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