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
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...
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| Main Authors: | , , , , , , , , , , , , , , |
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| Format: | Article (Journal) |
| Language: | English |
| Published: |
September 2024
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| In: |
European journal of cancer
Year: 2024, Volume: 209, Pages: 1-10 |
| ISSN: | 1879-0852 |
| DOI: | 10.1016/j.ejca.2024.114239 |
| Online Access: | Verlag, kostenfrei, Volltext: https://doi.org/10.1016/j.ejca.2024.114239 Verlag, kostenfrei, Volltext: https://www.sciencedirect.com/science/article/pii/S0959804924008955 
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| Author Notes: | Peter A. Fasching, Carolin C. Hack, Naiba Nabieva, Nicolai Maass, Bahriye Aktas, Sherko Kümmel, Christoph Thomssen, Christopher Wolf, Hans-Christian Kolberg, Cosima Brucker, Wolfgang Janni, Peter Dall, Andreas Schneeweiss, Frederik Marme, Marc W. Sütterlin, Matthias Ruebner, Anna-Katharin Theuser, Sara Kellner, Nadine M. Hofmann, Sybille Böhm, Katrin Almstedt, Hans-Joachim Lück, Sabine Schmatloch, Matthias Kalder, Christoph Uleer, Ingolf Jurhasz-Böss, Volker Hanf, Christian Jackisch, Volkmar Müller, Brigitte Rack, Erik Belleville, Diethelm Wallwiener, Achim Rody, Claudia Rauh, Christian M. Bayer, Sabrina Uhrig, Chloë Goossens, Hanna Huebner, Sara Y. Brucker, Alexander Hein, Tanja N. Fehm, Lothar Häberle |
| Summary: | 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. |
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| Item Description: | Online verfügbar: 21. Juli 2024, Artikelversion: 25. Juli 2024 Gesehen am 13.11.2024 |
| Physical Description: | Online Resource |
| ISSN: | 1879-0852 |
| DOI: | 10.1016/j.ejca.2024.114239 |