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. 2025 Sep 23:S1526-8209(25)00282-4.
doi: 10.1016/j.clbc.2025.09.013. Online ahead of print.

The Use and Impact on Treatment Decision of the 21-Gene Recurrence Score Assay for Patients With HR+/HER2- Early Breast Cancer in Portugal: A Nationwide Retrospective Cohort Study

Teresa Gantes Padrão  1 , Diana Pessoa  2 , Joana Alves Luís  3 , Diogo Alpuim Costa  4 , Mário Fontes E Sousa  4 , Ídilia Pina  5 , Susana Palma de Sousa  6 , Débora Cardoso  7 , Sandra Bento  8 , Joana Simões  9 , Ana Ferreira  10 , Renato Cunha  11 , Diogo Martins-Branco  2 , Tiago Dias Domingues  12 , José Luís Passos-Coelho  13 ; Portuguese 21-Gene Recurrence Score Assay National Study
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Free article

The Use and Impact on Treatment Decision of the 21-Gene Recurrence Score Assay for Patients With HR+/HER2- Early Breast Cancer in Portugal: A Nationwide Retrospective Cohort Study

Teresa Gantes Padrão et al. Clin Breast Cancer. .
Free article

Abstract

Background: The 21-Gene Recurrence Score Assay (Oncotype DX) is a genomic test that quantifies the likelihood of distant recurrence and predicts the potential benefit from adjuvant chemotherapy in patients with hormone receptor-positive (HR+), HER2- early breast cancer. This study aimed to evaluate the use and impact of the assay on treatment decision-making in Portugal through a nationwide retrospective cohort analysis.

Methods: We conducted a nationwide, multicenter, retrospective cohort study of 1083 RSA tests in 1079 patients with HR+/HER2- breast cancer between 2012 and 2021, across 36 oncology centers. We analyzed Recurrence Score (RS) distribution, adjuvant chemotherapy (ACT) prescribing patterns, correlations with clinicopathologic features, and recurrence data. Predictors of RS > 25 were evaluated using multivariable analysis and the Johns Hopkins RS Estimator (JHRE).

Results: Most patients had pT1 tumors (> 60%) and luminal B-like profiles (75%) with high hormone receptor expression (median ER 100%, PR 80%). RS > 25 occurred in 14.9% of node-negative and 15.5% of node-positive cases. ACT use shifted after TAILORx publication, with decreased use in RS < 16 and increased use in RS > 25, including among patients ≤50. ACT use for intermediate RS (16-25) dropped from 62% to 30% in patients ≤50. PR and Ki-67 were independent predictors of RS > 25. The JHRE showed moderate accuracy (53.6%) and specificity (47.7%). Among patients with a predicted RS > 25 risk < 5%, only 5% had actual high scores. Recurrence was observed in 2.3% of patients (median follow-up: 29 months).

Conclusion: RSA has been increasingly adopted in Portugal and influenced ACT decisions. PR and Ki-67 can help refine patient selection for RSA, particularly in resource-limited settings. Clinical trial results significantly shaped treatment patterns.

Keywords: Adjuvant chemotherapy; Genomic testing; Hormone receptor-positive; Oncotype DX; Real world.

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Conflict of interest statement

Disclosure The authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this paper.

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