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Open Access 09-05-2024 | Cytostatic Therapy | Research

Long-term prospective outcome data using EndoPredict as risk stratification and chemotherapy decision biomarker in hormone receptor-positive, HER2-negative early breast cancer

Authors: Evelyn Klein, Marion Kiechle, Adriana Josipovic, Sophie-Isabelle Anders, Aurelia Noske, Carolin Mogler, Alexander Hapfelmeier, Johannes Ettl

Published in: Breast Cancer Research and Treatment | Issue 1/2024

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Abstract

Purpose

To report the prospective long-term outcome data of patients whose chemotherapy decision was guided by the EndoPredict test.

Methods

Patients with hormone receptor-positive HER2-negative early breast cancer with 0–3 positive lymph nodes were enrolled. The EndoPredict test was carried out on all tumor samples. Treatment compliance, local recurrence, distant metastases, and survival were evaluated. Associations of EPclin risk stratification with 5-year disease-free survival and distant metastasis-free survival were evaluated by time-to-event analysis.

Results

368 consecutive patients were included in the analysis. Median follow-up was 8.2 years. EndoPredict allocated 238 (65%) in the low-risk and 130 (35%) patients in the high-risk group. Risk for disease recurrence or death in EPclin high-risk patients was twofold higher than in EPclin low-risk patients (hazard ratio [HR] 2.08; 95% CI 1.26–3.44; p = 0.004). EPclin low-risk patients had a 5-year disease-free survival of 95.3% (95% CI 92.6–98.0%). EPclin high-risk patients were at higher risk of developing distant metastases or death (HR 2.21; 95% CI 1.27–3.88; p = 0.005). EPclin high-risk patients who underwent chemotherapy had a 5-year DFS of 89.1% (95% CI 82.7–96.1%) in contrast to high-risk patients without chemotherapy (68.9%; 95% CI 56.2–84.5%; HR 0.46; 95% CI 0.23–0.95; p = 0.036). EPclin high-risk patients were at higher risk of experiencing distant metastases or death than EPclin low-risk patients regardless of menopausal status (premenopausal: HR 3.55; 95% CI 1.17–12.32; p = 0.025; postmenopausal: HR 1.92; 95% CI 0.99–3.7; p = 0.054).

Conclusion

EndoPredict can guide decisions on adjuvant chemotherapy in early luminal breast cancer. EndoPredict risk stratification is also applicable in premenopausal women.
Literature
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go back to reference Jank P, Lindner JL, Lehmann A, Pfitzner BM, Blohmer JU, Horst D et al (2022) Comparison of risk assessment in 1652 early ER positive, HER2 negative breast cancer in a real-world data set: classical pathological parameters vs. 12-gene molecular assay (EndoPredict). Breast Cancer Res Treat 191:327–333. https://doi.org/10.1007/s10549-021-06415-0CrossRefPubMed Jank P, Lindner JL, Lehmann A, Pfitzner BM, Blohmer JU, Horst D et al (2022) Comparison of risk assessment in 1652 early ER positive, HER2 negative breast cancer in a real-world data set: classical pathological parameters vs. 12-gene molecular assay (EndoPredict). Breast Cancer Res Treat 191:327–333. https://​doi.​org/​10.​1007/​s10549-021-06415-0CrossRefPubMed
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go back to reference Ettl J, Blohmer J-U, Denkert C, Beier L, Klein E, Neuser P, Keller M, Untch M, Wittenberg M, Kiechle M (2019) RESCUE: reaching for evidence-based chemotherapy use in endocrine sensitive breast cancer—a prospective non-interventional study on risk assessment by the endopredict test and long-term patient outcome in early luminal breast cancer. Ann Oncol 30(SUPPLEMENT 3):III25CrossRef Ettl J, Blohmer J-U, Denkert C, Beier L, Klein E, Neuser P, Keller M, Untch M, Wittenberg M, Kiechle M (2019) RESCUE: reaching for evidence-based chemotherapy use in endocrine sensitive breast cancer—a prospective non-interventional study on risk assessment by the endopredict test and long-term patient outcome in early luminal breast cancer. Ann Oncol 30(SUPPLEMENT 3):III25CrossRef
Metadata
Title
Long-term prospective outcome data using EndoPredict as risk stratification and chemotherapy decision biomarker in hormone receptor-positive, HER2-negative early breast cancer
Authors
Evelyn Klein
Marion Kiechle
Adriana Josipovic
Sophie-Isabelle Anders
Aurelia Noske
Carolin Mogler
Alexander Hapfelmeier
Johannes Ettl
Publication date
09-05-2024
Publisher
Springer US
Published in
Breast Cancer Research and Treatment / Issue 1/2024
Print ISSN: 0167-6806
Electronic ISSN: 1573-7217
DOI
https://doi.org/10.1007/s10549-024-07346-2

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