Prognostic Value of Oncotype DX Recurrence Score in Early-Stage Hormone Receptor-Positive, HER2-Negative Breast Cancer: A Real-World Experience

Abstract

Background: The Oncotype DX 21-gene recurrence score (ODx-RS) assay guides adjuvant chemotherapy decisions in early-stage hormone receptor-positive (HR+), HER2-negative breast cancer. While validated in large clinical trials, real-world data from single-center cohorts—particularly in middle-income countries—are limited. This study aimed to evaluate the prognostic value of ODx-RS and its association with treatment selection and progression-free survival (PFS) in a Turkish cohort. Methods: We retrospectively reviewed 64 female patients diagnosed with pT1–2, pN0–1mic, M0 HR+/HER2− breast cancer who underwent ODx-RS testing at Memorial Antalya Hospital between 2015–2024. Patients were stratified into low (<18) and intermediate/high (≥18) genomic risk groups. Treatment allocation to endocrine therapy (ET) alone or ET plus chemotherapy (ET+CT) followed multidisciplinary tumor board recommendations. Clinicopathological variables and ODx-RS were compared between groups. PFS was estimated using Kaplan–Meier analysis, and prognostic factors were assessed with Cox regression. Results: Median follow-up was 35.5 months. The median ODx-RS was 18, with 46.9% scoring <18 and 53.1% ≥18. Patients with ODx-RS ≥18 were significantly more likely to receive chemotherapy (95% vs. 34.1%, p<0.001). Grade 3 tumors were more prevalent in the ET+CT group (25% vs. 4.5%, p=0.004). Five-year PFS was higher in ET-only patients compared to ET+CT (94.3% vs. 62.4%, p=0.006) and in ODx-RS <18 vs. ≥18 (95.8% vs. 70.6%, p=0.016). In multivariate analysis, only stage II disease remained an independent predictor of progression (HR=8.85, 95% CI: 1.53–51.01, p=0.015). Conclusions: ODx-RS <18 was associated with excellent 5-year PFS, supporting the omission of chemotherapy in these patients without compromising outcomes. Tumor stage, rather than ODx-RS or menopausal status, was the strongest independent prognostic factor. These findings reinforce the clinical utility of ODx-RS in tailoring adjuvant therapy for early-stage HR+/HER2− breast cancer in real-world practice.

Keywords

• : breast cancer
• Oncotype DX
• recurrence score
• hormone receptor-positive
• HER2-negative
• progression-free survival
• real-world study

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