Invasive disease-free and overall survival after (neo)adjuvant chemotherapy in postmenopausal patients with hormone receptor-positive, HER2-negative early breast cancer treated with upfront letrozole: Experiences from the phase IV PreFace trial

Beierlein M, Häberle L, Nabieva N, Maass N, Aktas B, Kümmel S, Thomssen C, Wolf C, Kolberg HC, Brucker C, Janni W, Dall P, Schneeweiss A, Marme F, Sütterlin MW, Rübner M, Theuser AK, Hofmann NM, Böhm S, Almstedt K, Kellner S, Gaß P, Lück HJ, Hein A, Schmatloch S, Kalder M, Uleer C, Juhasz-Böss I, Hanf V, Jackisch C, Müller V, Rack B, Belleville E, Wallwiener D, Rody A, Rauh C, Bayer CM, Uhrig S, Hübner H, Goossens C, Brucker SY, Hack C, Fehm TN, Fasching P (2025)

Publication Type: Journal article

Publication year: 2025

Journal

DOI: 10.1002/ijc.70037

Abstract

Patients with hormone receptor-positive (HRpos), HER2-negative (HER2neg) breast cancer (BC) benefit less from neoadjuvant chemotherapy (NACT) than patients with triple-negative and HER2-positive BC. In this retrospective analysis of the phase IV PreFace clinical trial (NCT01908556), where postmenopausal HRpos BC patients (n = 3297) were treated with 5-year upfront adjuvant letrozole therapy, we evaluated the prognosis of patients treated with adjuvant versus neoadjuvant chemotherapy in HRpos/HER2neg early-stage BC. HRpos/HER2neg patients with information on (neo)adjuvant chemotherapy (n = 2895) were retrospectively selected from all patients enrolled in the PreFace trial. Invasive disease-free survival (iDFS) and overall survival (OS) were compared between patient groups that were treated with neoadjuvant or adjuvant chemotherapy. Chemotherapy was given to 1051 patients (36.3% of all patients), of which 874 (83.2%) received adjuvant chemotherapy and 177 (16.8%) NACT. Pathologic complete response (pCR) rate in the NACT group was 6.9%. Patients treated with NACT had a worse outcome than those treated with adjuvant chemotherapy (5-year iDFS rate 81% vs. 88%; 5-year OS rate 89% vs. 93%). This effect was maintained after adjusting for age, BMI, lymph node status, grading, tumor size, and histology (hazard ratio for iDFS: 1.95 (95%CI: 1.28–2.95); hazard ratio for OS: 2.13 (95%CI: 1.24–3.66)). Further adjustment for taxane-based regimes did not alter results. In conclusion, in this retrospective analysis of patients with early-stage HRpos/HER2neg BC, patients with NACT had a more unfavorable prognosis than patients treated adjuvantly, independent of patient and tumor characteristics. Prognosis of neoadjuvant patients might be affected by resistance mechanisms, warranting further investigation.

Authors with CRIS profile

Involved external institutions

Universitätsklinikum Gießen und Marburg (UKGM) Germany (DE) Universitätsklinikum Schleswig-Holstein (UKSH) Germany (DE) Universitätsklinikum Leipzig Germany (DE) Universitätsklinikum Freiburg Germany (DE) Sana Kliniken AG Germany (DE) Universitätsklinikum Hamburg-Eppendorf (UKE) Germany (DE) Universitätsklinikum Ulm Germany (DE) ClinSol GmbH & Co.KG Germany (DE) Universitätsklinikum Tübingen Germany (DE) Kliniken Essen-Mitte Germany (DE) Martin-Luther-Universität Halle-Wittenberg (MLU) Germany (DE) Marienhospital Bottrop Germany (DE) Städtisches Klinikum Lüneburg Germany (DE) Universitätsklinikum Heidelberg Germany (DE) Klinikum Fürth Germany (DE) Universitätsklinikum Mannheim / University Medical Centre Mannheim (Universitätsmedizin Mannheim) Germany (DE) Institut für Frauengesundheit GmbH Germany (DE) Gynäkologisch-Onkologische Praxis Hannover Germany (DE) Elisabeth-Krankenhaus Germany (DE) Universitätsklinikum Düsseldorf Germany (DE)

How to cite

APA:

Beierlein, M., Häberle, L., Nabieva, N., Maass, N., Aktas, B., Kümmel, S.,... Fasching, P. (2025). Invasive disease-free and overall survival after (neo)adjuvant chemotherapy in postmenopausal patients with hormone receptor-positive, HER2-negative early breast cancer treated with upfront letrozole: Experiences from the phase IV PreFace trial. International Journal of Cancer. https://doi.org/10.1002/ijc.70037

MLA:

Beierlein, Milena, et al. "Invasive disease-free and overall survival after (neo)adjuvant chemotherapy in postmenopausal patients with hormone receptor-positive, HER2-negative early breast cancer treated with upfront letrozole: Experiences from the phase IV PreFace trial." International Journal of Cancer (2025).

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