Fasching, Peter A; Hack, Carolin C; Nabieva, Naiba; Maass, Nicolai; Aktas, Bahriye; Kümmel, Sherko; Thomssen, Christoph; Wolf, Christopher; Kolberg, Hans-Christian; Brucker, Cosima; Janni, Wolfgang; Dall, Peter; Schneeweiss, Andreas; Marme, Frederik; Sütterlin, Marc W; Ruebner, Matthias; Theuser, Anna-Katharin; Kellner, Sara; Hofmann, Nadine M; Böhm, Sybille; ... (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, p. 114239. Elsevier 10.1016/j.ejca.2024.114239
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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.
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Gynaecology, Paediatrics and Endocrinology (DFKE) > Clinic of Gynaecology |
UniBE Contributor: |
Rauh, Claudia |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
1879-0852 |
Publisher: |
Elsevier |
Language: |
English |
Submitter: |
Pubmed Import |
Date Deposited: |
29 Jul 2024 12:47 |
Last Modified: |
25 Aug 2024 00:18 |
Publisher DOI: |
10.1016/j.ejca.2024.114239 |
PubMed ID: |
39059184 |
Uncontrolled Keywords: |
Aromatase inhibitors CDK4/6 inhibitors Early breast cancer Hormone therapy Letrozole Prognosis |
BORIS DOI: |
10.48350/199341 |
URI: |
https://boris.unibe.ch/id/eprint/199341 |
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