Efficacy and safety of everolimus plus exemestane in patients with hormone receptor-positive, HER-2-negative advanced breast cancer: Results from the open-label, multicentre, non-interventional BRAWO study
Lüftner D, Schuetz F, Schneeweiss A, Hartkopf A, Bloch W, Decker T, Uleer C, Stötzer O, Foerster F, Schmidt M, Mundhenke C, Tesch H, Jackisch C, Fischer T, Kreuzeder J, Guderian G, Fasching P (2024)
Publication Type: Journal article
Publication year: 2024
Journal
Book Volume: 155
Pages Range: 128-138
Journal Issue: 1
DOI: 10.1002/ijc.34912
Abstract
BRAWO, a real-world study, assessed the efficacy, quality of life (QoL) and safety of EVE + EXE in postmenopausal women with HR+/HER2– advanced breast cancer (ABC) in routine clinical practice. Postmenopausal women with HR+/HER2-ABC with recurrence or progression after a NSAI were included. Primary Observation parameters included the evaluation of the effectiveness of EVE + EXE. A multivariate-analysis using Cox proportional hazard model was built to identify predictors of progression. Overall, 2100 patients were enrolled (August 2012–December 2017); 2074 were evaluable for efficacy and safety analyses. Majority of patients (60.6%) received EVE + EXE as first (28.7%) or second-line (31.9%) therapy. Visceral metastases were present in 54.1% patients. Median progression-free survival (mPFS) reported as 6.6 months (95%CI: 6.3–7.0). Multivariate-analysis in a subset of patients (n = 1837) found higher body mass index (BMI) and non-visceral metastases to be independent predictors of favorable PFS. Patients with a BMI of 20 to <25 had a mPFS of 6.0 (95%CI: 5.4–6.4) and those with a BMI ≥30 had mPFS of 8.5 (95%CI: 6.9–9.9). 41.2% patients achieved stable disease and 7.3% partial response. No major changes were observed QoL; 86.4% patients received stomatitis prophylaxis and 41.4% experienced EVE related AEs of stomatitis, mainly low grade. AEs occurred in 91.2% of patients, of which stomatitis (42.6%) and fatigue (19.8%) were most frequent. The BRAWO study provides real-world evidence of efficacy and safety of EVE + EXE in patients with HR+, HER2− ABC. A high BMI and the absence of visceral metastases were independent predictors of PFS in this cohort of patients.
Authors with CRIS profile
Involved external institutions
Medizinische Hochschule Brandenburg "Theodor Fontane" / Brandenburg Medical School "Theodor Fontane"
Germany (DE)
Universitätsklinikum Heidelberg
Germany (DE)
Universitätsklinikum Tübingen
Germany (DE)
Deutsche Sporthochschule Köln
Germany (DE)
Studienzentrum Onkologie Ravensburg
Germany (DE)
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Germany (DE)
Onkologie Bethanien
Germany (DE)
Sana Klinikum Offenbach
Germany (DE)
Winicker Norimed GmbH
Germany (DE)
Novartis AG
Switzerland (CH)
Germany (DE)
Universitätsklinikum Heidelberg
Germany (DE)
Universitätsklinikum Tübingen
Germany (DE)
Deutsche Sporthochschule Köln
Germany (DE)
Studienzentrum Onkologie Ravensburg
Germany (DE)
Universitätsmedizin der Johannes Gutenberg-Universität Mainz
Germany (DE)
Onkologie Bethanien
Germany (DE)
Sana Klinikum Offenbach
Germany (DE)
Winicker Norimed GmbH
Germany (DE)
Novartis AG
Switzerland (CH)
How to cite
APA:
Lüftner, D., Schuetz, F., Schneeweiss, A., Hartkopf, A., Bloch, W., Decker, T.,... Fasching, P. (2024). Efficacy and safety of everolimus plus exemestane in patients with hormone receptor-positive, HER-2-negative advanced breast cancer: Results from the open-label, multicentre, non-interventional BRAWO study. International Journal of Cancer, 155(1), 128-138. https://doi.org/10.1002/ijc.34912
MLA:
Lüftner, Diana, et al. "Efficacy and safety of everolimus plus exemestane in patients with hormone receptor-positive, HER-2-negative advanced breast cancer: Results from the open-label, multicentre, non-interventional BRAWO study." International Journal of Cancer 155.1 (2024): 128-138.
BibTeX: Download