Real-world risk of recurrence and treatment outcomes with adjuvant endocrine therapy in patients with stage II-III HR+/HER2- early breast cancer
O'Shaughnessy J, Tolaney SM, Yardley DA, Hart L, Razavi P, Fasching P, Janni W, Schwartzberg L, Kim J, Akdere M, McDermott C, Khakwani A, Pathak P, Graff SL (2025)
Publication Language: English
Publication Type: Journal article
Publication year: 2025
Journal
Book Volume: 81
Article Number: 104437
DOI: 10.1016/j.breast.2025.104437
Abstract
Background: Despite adjuvant endocrine therapy (ET), recurrence is still a concern for patients with HR+/HER2- early breast cancer (EBC). We assessed recurrence risk in real-world patients with stage II/III HR+/HER2- EBC treated with adjuvant ET. Methods: A retrospective analysis was conducted using the ConcertAI Patient360 database (January 1995 to April 2021) of patients with stage II/III HR+/HER2- EBC ≥18 years who underwent surgery and received adjuvant ET. Risk of recurrence was assessed using invasive disease-free survival (iDFS) with adapted STEEP criteria. An ET subanalysis evaluated iDFS, distant disease-free survival, and overall survival in patients receiving adjuvant non-steroidal aromatase inhibitors (NSAI) vs tamoxifen. Results: In the full analysis cohort (N = 3133), the risk of an iDFS event was 26.1 % at 5 years, rising to 45.0 % at 10 years. Among patients with stage II disease, the risk of an iDFS event at 5 and 10 years was 22.7 % and 40.5 %, respectively; stage III 5- and 10-year risk was 40.4 % and 62.9 %. Patients with node-negative disease had 5- and 10-year risks of 22.1 % and 36.9 %, respectively; node-positive 5- and 10-year risk was 28.9 % and 49.4 %. ET subanalysis showed improved iDFS with NSAI ± ovarian function suppression vs tamoxifen ± ovarian function suppression (HR, 0.83; 95 % CI, 0.69–0.98; p = 0.031); this trend was observed regardless of menopausal status. Conclusions: This real-world study highlights the considerable risk of recurrence with adjuvant ET in patients with stage II or III HR+/HER2- EBC (including node-negative disease) and confirms the need for improved treatment options.
Authors with CRIS profile
Involved external institutions
Baylor University Medical Center
United States (USA) (US)
Dana–Farber Cancer Institute
United States (USA) (US)
Sarah Cannon Research Institute (SCRI)
United States (USA) (US)
Memorial Sloan Kettering Cancer Center
United States (USA) (US)
Universitätsklinikum Ulm
Germany (DE)
Renown Institute for Heart & Vascular Health
United States (USA) (US)
Novartis AG
Switzerland (CH)
Novartis Ireland Limited
Ireland (IE)
Novartis (UK)
United Kingdom (GB)
Brown University
United States (USA) (US)
United States (USA) (US)
Dana–Farber Cancer Institute
United States (USA) (US)
Sarah Cannon Research Institute (SCRI)
United States (USA) (US)
Memorial Sloan Kettering Cancer Center
United States (USA) (US)
Universitätsklinikum Ulm
Germany (DE)
Renown Institute for Heart & Vascular Health
United States (USA) (US)
Novartis AG
Switzerland (CH)
Novartis Ireland Limited
Ireland (IE)
Novartis (UK)
United Kingdom (GB)
Brown University
United States (USA) (US)
How to cite
APA:
O'Shaughnessy, J., Tolaney, S.M., Yardley, D.A., Hart, L., Razavi, P., Fasching, P.,... Graff, S.L. (2025). Real-world risk of recurrence and treatment outcomes with adjuvant endocrine therapy in patients with stage II-III HR+/HER2- early breast cancer. The Breast, 81. https://doi.org/10.1016/j.breast.2025.104437
MLA:
O'Shaughnessy, Joyce, et al. "Real-world risk of recurrence and treatment outcomes with adjuvant endocrine therapy in patients with stage II-III HR+/HER2- early breast cancer." The Breast 81 (2025).
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