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

Yıl 2025, Cilt: 16 Sayı: 4, 555 - 563, 01.01.2026

Öz

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.

Kaynakça

  • Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF et al. Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. N Engl J Med 2018; 379: 111–21.
  • Sparano JA, Gray RJ, Ravdin PM, Makower DF, Pritchard KI, Albain KS et al. Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer. N Engl J Med 2019; 380: 2395–405.
  • Harris LN, Ismaila N, McShane LM, Andre F, Collyar DE, Gonzalez-Angulo AM et al. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol 2016; 34: 1134–50.
  • Piccart M, van 't Veer LJ, Poncet C, Lopes Cardozo JMN, Delaloge S, Pierga JY et al. 70-gene signature as an aid for treatment decisions in early breast cancer: updated results of the phase 3 randomised MINDACT trial with an exploratory analysis by age. Lancet Oncol 2021; 22: 476–88.
  • Unal C, Aksoy S, Karaagaç M, Mert S, Geredeli C, Sendur MAN et al. Survival results according to Oncotype Dx recurrence score in patients with hormone receptor positive HER-2 negative early-stage breast cancer: first multicenter Oncotype Dx recurrence score survival data of Turkey. Front Oncol 2023; 13: 1151733.
  • Paik S, Tang G, Shak S, Kim C, Baker J, Zujewski J et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol 2006; 24: 3726–34.
  • Henry NL, Ismaila N, Hayes DF, Jagsi R, Somerfield MR, Meyerfalvy C et al. Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer: Update of the ASCO Endorsement of the Cancer Care Ontario Guideline. J Clin Oncol 2019; 37: 1965–77.
  • Andre F, Ismaila N, Henry NL, Somerfield MR, Bast RC, Barlow W et al. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: ASCO Clinical Practice Guideline Update-Integration of Results From TAILORx. J Clin Oncol 2019; 37: 1956–64.
  • Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005; 365: 1687–717.
  • Peto R, Davies C, Godwin J, Gray R, Pan HC, Clarke M et al. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet 2012; 379: 432–44.
  • Clark BZ, Beriwal S, Dabbs DJ, Bhargava R. Impact of progesterone receptor semiquantitative immunohistochemical result on Oncotype DX recurrence score: a quality assurance study of 1074 cases. Appl Immunohistochem Mol Morphol 2013; 21: 287–91.
  • Glasgow A, Shriver LC, Richmond J, Sannareddy S, Karaman R, Karakas C et al. Correlation between modified Magee equation-2 and Oncotype-Dx recurrence scores using both traditional and TAILORx cutoffs and the clinical application of the Magee Decision Algorithm: a single institutional review. Breast Cancer 2021; 28: 321–28.
  • Ozmen V, Atasoy T, Gokmen E, Ozdogan M, Guler N, Uras C et al. Correlations Between Oncotype DX Recurrence Score and Classic Risk Factors in Early Breast Cancer: Results of A Prospective Multicenter Study in Turkey. J Breast Health 2016; 12: 107–11.
  • Park S, Han W, Kim J, Kim MK, Lee E, Kim EK et al. Adjuvant chemotherapy and survival among patients 70 years of age and younger with node-negative breast cancer and the 21-gene recurrence score of 26-30. Breast Cancer Res 2019; 21: 110.
  • Henry NL, Ismaila N, Hayes DF, Jagsi R, Somerfield MR, Meyerfalvy C et al. Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer: American Society of Clinical Oncology Endorsement of Cancer Care Ontario Guideline Recommendations. J Clin Oncol 2016; 34: 2303–11.
  • Williams AD, Payne AS, Graham SJ, Carrigan AJ, Showalter SL, Brenin DR et al. Is Age Trumping Genetic Profiling in Clinical Practice? Relationship of Chemotherapy Recommendation and Oncotype DX Recurrence Score in Patients Aged < 50 Years versus ≥ 50 Years, and Trends Over Time. Ann Surg Oncol 2018; 25: 2875–83.
  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin 2021; 71: 209–49.
  • Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF et al. Prospective Validation of a 21-Gene Expression Assay in Breast Cancer. N Engl J Med 2015; 373: 2005–14.
  • Mamounas EP, Tang G, Fisher B, Paik S, Shak S, Costantino JP et al. Association between the 21-gene recurrence score assay and risk of locoregional recurrence in node-negative, estrogen receptor-positive breast cancer: results from NSABP B-14 and NSABP B-20. J Clin Oncol 2010; 28: 1677–83.

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

Yıl 2025, Cilt: 16 Sayı: 4, 555 - 563, 01.01.2026

Öz

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.

Kaynakça

  • Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF et al. Adjuvant Chemotherapy Guided by a 21-Gene Expression Assay in Breast Cancer. N Engl J Med 2018; 379: 111–21.
  • Sparano JA, Gray RJ, Ravdin PM, Makower DF, Pritchard KI, Albain KS et al. Clinical and Genomic Risk to Guide the Use of Adjuvant Therapy for Breast Cancer. N Engl J Med 2019; 380: 2395–405.
  • Harris LN, Ismaila N, McShane LM, Andre F, Collyar DE, Gonzalez-Angulo AM et al. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: American Society of Clinical Oncology Clinical Practice Guideline. J Clin Oncol 2016; 34: 1134–50.
  • Piccart M, van 't Veer LJ, Poncet C, Lopes Cardozo JMN, Delaloge S, Pierga JY et al. 70-gene signature as an aid for treatment decisions in early breast cancer: updated results of the phase 3 randomised MINDACT trial with an exploratory analysis by age. Lancet Oncol 2021; 22: 476–88.
  • Unal C, Aksoy S, Karaagaç M, Mert S, Geredeli C, Sendur MAN et al. Survival results according to Oncotype Dx recurrence score in patients with hormone receptor positive HER-2 negative early-stage breast cancer: first multicenter Oncotype Dx recurrence score survival data of Turkey. Front Oncol 2023; 13: 1151733.
  • Paik S, Tang G, Shak S, Kim C, Baker J, Zujewski J et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol 2006; 24: 3726–34.
  • Henry NL, Ismaila N, Hayes DF, Jagsi R, Somerfield MR, Meyerfalvy C et al. Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer: Update of the ASCO Endorsement of the Cancer Care Ontario Guideline. J Clin Oncol 2019; 37: 1965–77.
  • Andre F, Ismaila N, Henry NL, Somerfield MR, Bast RC, Barlow W et al. Use of Biomarkers to Guide Decisions on Adjuvant Systemic Therapy for Women With Early-Stage Invasive Breast Cancer: ASCO Clinical Practice Guideline Update-Integration of Results From TAILORx. J Clin Oncol 2019; 37: 1956–64.
  • Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet 2005; 365: 1687–717.
  • Peto R, Davies C, Godwin J, Gray R, Pan HC, Clarke M et al. Comparisons between different polychemotherapy regimens for early breast cancer: meta-analyses of long-term outcome among 100,000 women in 123 randomised trials. Lancet 2012; 379: 432–44.
  • Clark BZ, Beriwal S, Dabbs DJ, Bhargava R. Impact of progesterone receptor semiquantitative immunohistochemical result on Oncotype DX recurrence score: a quality assurance study of 1074 cases. Appl Immunohistochem Mol Morphol 2013; 21: 287–91.
  • Glasgow A, Shriver LC, Richmond J, Sannareddy S, Karaman R, Karakas C et al. Correlation between modified Magee equation-2 and Oncotype-Dx recurrence scores using both traditional and TAILORx cutoffs and the clinical application of the Magee Decision Algorithm: a single institutional review. Breast Cancer 2021; 28: 321–28.
  • Ozmen V, Atasoy T, Gokmen E, Ozdogan M, Guler N, Uras C et al. Correlations Between Oncotype DX Recurrence Score and Classic Risk Factors in Early Breast Cancer: Results of A Prospective Multicenter Study in Turkey. J Breast Health 2016; 12: 107–11.
  • Park S, Han W, Kim J, Kim MK, Lee E, Kim EK et al. Adjuvant chemotherapy and survival among patients 70 years of age and younger with node-negative breast cancer and the 21-gene recurrence score of 26-30. Breast Cancer Res 2019; 21: 110.
  • Henry NL, Ismaila N, Hayes DF, Jagsi R, Somerfield MR, Meyerfalvy C et al. Role of Patient and Disease Factors in Adjuvant Systemic Therapy Decision Making for Early-Stage, Operable Breast Cancer: American Society of Clinical Oncology Endorsement of Cancer Care Ontario Guideline Recommendations. J Clin Oncol 2016; 34: 2303–11.
  • Williams AD, Payne AS, Graham SJ, Carrigan AJ, Showalter SL, Brenin DR et al. Is Age Trumping Genetic Profiling in Clinical Practice? Relationship of Chemotherapy Recommendation and Oncotype DX Recurrence Score in Patients Aged < 50 Years versus ≥ 50 Years, and Trends Over Time. Ann Surg Oncol 2018; 25: 2875–83.
  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A et al. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin 2021; 71: 209–49.
  • Sparano JA, Gray RJ, Makower DF, Pritchard KI, Albain KS, Hayes DF et al. Prospective Validation of a 21-Gene Expression Assay in Breast Cancer. N Engl J Med 2015; 373: 2005–14.
  • Mamounas EP, Tang G, Fisher B, Paik S, Shak S, Costantino JP et al. Association between the 21-gene recurrence score assay and risk of locoregional recurrence in node-negative, estrogen receptor-positive breast cancer: results from NSABP B-14 and NSABP B-20. J Clin Oncol 2010; 28: 1677–83.
Toplam 19 adet kaynakça vardır.

Ayrıntılar

Birincil Dil İngilizce
Konular Klinik Onkoloji, Kemoterapi
Bölüm Araştırma Makalesi
Yazarlar

Selami Bayram 0000-0002-0930-5025

Ali Murat Tatlı 0000-0001-9696-1102

Mustafa Özdoğan 0000-0001-9512-4828

Gönderilme Tarihi 23 Ağustos 2025
Kabul Tarihi 24 Kasım 2025
Yayımlanma Tarihi 1 Ocak 2026
Yayımlandığı Sayı Yıl 2025 Cilt: 16 Sayı: 4

Kaynak Göster

APA Bayram, S., Tatlı, A. M., & Özdoğan, M. (2026). Prognostic Value of Oncotype DX Recurrence Score in Early-Stage Hormone Receptor-Positive, HER2-Negative Breast Cancer: A Real-World Experience. Turkish Journal of Clinics and Laboratory, 16(4), 555-563. https://doi.org/10.18663/tjcl.1770581
AMA Bayram S, Tatlı AM, Özdoğan M. Prognostic Value of Oncotype DX Recurrence Score in Early-Stage Hormone Receptor-Positive, HER2-Negative Breast Cancer: A Real-World Experience. TJCL. Ocak 2026;16(4):555-563. doi:10.18663/tjcl.1770581
Chicago Bayram, Selami, Ali Murat Tatlı, ve Mustafa Özdoğan. “Prognostic Value of Oncotype DX Recurrence Score in Early-Stage Hormone Receptor-Positive, HER2-Negative Breast Cancer: A Real-World Experience”. Turkish Journal of Clinics and Laboratory 16, sy. 4 (Ocak 2026): 555-63. https://doi.org/10.18663/tjcl.1770581.
EndNote Bayram S, Tatlı AM, Özdoğan M (01 Ocak 2026) Prognostic Value of Oncotype DX Recurrence Score in Early-Stage Hormone Receptor-Positive, HER2-Negative Breast Cancer: A Real-World Experience. Turkish Journal of Clinics and Laboratory 16 4 555–563.
IEEE S. Bayram, A. M. Tatlı, ve M. Özdoğan, “Prognostic Value of Oncotype DX Recurrence Score in Early-Stage Hormone Receptor-Positive, HER2-Negative Breast Cancer: A Real-World Experience”, TJCL, c. 16, sy. 4, ss. 555–563, 2026, doi: 10.18663/tjcl.1770581.
ISNAD Bayram, Selami vd. “Prognostic Value of Oncotype DX Recurrence Score in Early-Stage Hormone Receptor-Positive, HER2-Negative Breast Cancer: A Real-World Experience”. Turkish Journal of Clinics and Laboratory 16/4 (Ocak2026), 555-563. https://doi.org/10.18663/tjcl.1770581.
JAMA Bayram S, Tatlı AM, Özdoğan M. Prognostic Value of Oncotype DX Recurrence Score in Early-Stage Hormone Receptor-Positive, HER2-Negative Breast Cancer: A Real-World Experience. TJCL. 2026;16:555–563.
MLA Bayram, Selami vd. “Prognostic Value of Oncotype DX Recurrence Score in Early-Stage Hormone Receptor-Positive, HER2-Negative Breast Cancer: A Real-World Experience”. Turkish Journal of Clinics and Laboratory, c. 16, sy. 4, 2026, ss. 555-63, doi:10.18663/tjcl.1770581.
Vancouver Bayram S, Tatlı AM, Özdoğan M. Prognostic Value of Oncotype DX Recurrence Score in Early-Stage Hormone Receptor-Positive, HER2-Negative Breast Cancer: A Real-World Experience. TJCL. 2026;16(4):555-63.


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