Prognostic impact of selection criteria of current adjuvant endocrine therapy trials NATALEE and monarchE in postmenopausal HRpos/HER2neg breast cancer patients treated with upfront letrozole

Fasching P, Hack C, 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, Kellner S, Hofmann NM, Böhm S, Almstedt K, Lück HJ, Schmatloch S, Kalder M, Uleer C, Jurhasz-Böss I, Hanf V, Jackisch C, Müller V, Rack B, Belleville E, Wallwiener D, Rody A, Rauh C, Bayer CM, Uhrig S, Goossens C, Hübner H, Brucker SY, Hein A, Fehm TN, Häberle L (2024)

Publication Type: Journal article

Publication year: 2024

Journal

Book Volume: 209

Article Number: 114239

DOI: 10.1016/j.ejca.2024.114239

Abstract

Background: The monarchE and NATALEE trials demonstrated the benefit of CDK4/6 inhibitor (CDK4/6i) therapy in adjuvant breast cancer (BC) treatment. Patient selection, based on clinical characteristics, delineated those at high (monarchE) and high/intermediate recurrence risk (NATALEE). This study employed a historical patient cohort to describe the proportion and prognosis of patients eligible for adjuvant CDK4/6i trials. Methods: Between 2009 and 2011, 3529 patients were enrolled in the adjuvant PreFace clinical trial (NCT01908556). Eligibility criteria included postmenopausal patients with hormone receptor-positive (HRpos) BC for whom a five-year upfront therapy with letrozole was indicated. Patients were categorized into prognostic groups according to monarchE and NATALEE inclusion criteria, and their invasive disease-free survival (iDFS) and overall survival (OS) were assessed. Results: Among 2891 HRpos patients, 384 (13.3 %) met the primary monarchE inclusion criteria. The majority (n = 261) qualified due to having ≥ 4 positive lymph nodes. For NATALEE, 915 out of 2886 patients (31.7 %) met the eligibility criteria, with 126 patients (13.7 %) being node-negative. Patients from monarchE with ≥ 4 positive lymph nodes and NATALEE with stage III BC exhibited the poorest prognosis (3-year iDFS rate 0.87). Patients ineligible for the trials demonstrated prognoses similar to the most favorable patient groups within the eligibility criteria. Conclusion: Patient populations eligible for monarchE and NATALEE trials differed. Nearly a third of the postmenopausal HRpos population, previously under upfront letrozole treatment, met the NATALEE prognostic eligibility criteria. As certain eligible groups had a prognosis similar to non-eligible patients, it might be interesting to explore additional patient groups for CDK4/6i therapy.

Authors with CRIS profile

Involved external institutions

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

How to cite

APA:

Fasching, P., Hack, C., Nabieva, N., Maass, N., Aktas, B., Kümmel, S.,... Häberle, L. (2024). Prognostic impact of selection criteria of current adjuvant endocrine therapy trials NATALEE and monarchE in postmenopausal HRpos/HER2neg breast cancer patients treated with upfront letrozole. European Journal of Cancer, 209. https://doi.org/10.1016/j.ejca.2024.114239

MLA:

Fasching, Peter, et al. "Prognostic impact of selection criteria of current adjuvant endocrine therapy trials NATALEE and monarchE in postmenopausal HRpos/HER2neg breast cancer patients treated with upfront letrozole." European Journal of Cancer 209 (2024).

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