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
© 2024 UICC..
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.
| Medienart: |
E-Artikel |
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| Erscheinungsjahr: |
2024 |
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| Erschienen: |
2024 |
| Enthalten in: |
Zur Gesamtaufnahme - year:2024 |
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| Enthalten in: |
International journal of cancer - (2024) vom: 06. März |
| Sprache: |
Englisch |
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| Beteiligte Personen: |
Lüftner, Diana [VerfasserIn] |
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| Links: |
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| Themen: |
Advanced breast cancer |
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| Anmerkungen: |
Date Revised 06.03.2024 published: Print-Electronic Citation Status Publisher |
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| doi: |
10.1002/ijc.34912 |
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| funding: |
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| Förderinstitution / Projekttitel: |
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| PPN (Katalog-ID): |
NLM369367685 |
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| 100 | 1 | |a Lüftner, Diana |e verfasserin |4 aut | |
| 245 | 1 | 0 | |a Efficacy and safety of everolimus plus exemestane in patients with hormone receptor-positive, HER-2-negative advanced breast cancer |b Results from the open-label, multicentre, non-interventional BRAWO study |
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| 520 | |a © 2024 UICC. | ||
| 520 | |a 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 | ||
| 650 | 4 | |a Journal Article | |
| 650 | 4 | |a HER2- | |
| 650 | 4 | |a HR+ | |
| 650 | 4 | |a advanced breast cancer | |
| 650 | 4 | |a everolimus | |
| 650 | 4 | |a exemestane | |
| 700 | 1 | |a Schuetz, Florian |e verfasserin |4 aut | |
| 700 | 1 | |a Schneeweiss, Andreas |e verfasserin |4 aut | |
| 700 | 1 | |a Hartkopf, Andreas |e verfasserin |4 aut | |
| 700 | 1 | |a Bloch, Wilhelm |e verfasserin |4 aut | |
| 700 | 1 | |a Decker, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Uleer, Christoph |e verfasserin |4 aut | |
| 700 | 1 | |a Stötzer, Oliver |e verfasserin |4 aut | |
| 700 | 1 | |a Foerster, Frank |e verfasserin |4 aut | |
| 700 | 1 | |a Schmidt, Marcus |e verfasserin |4 aut | |
| 700 | 1 | |a Mundhenke, Christoph |e verfasserin |4 aut | |
| 700 | 1 | |a Tesch, Hans |e verfasserin |4 aut | |
| 700 | 1 | |a Jackisch, Christian |e verfasserin |4 aut | |
| 700 | 1 | |a Fischer, Thomas |e verfasserin |4 aut | |
| 700 | 1 | |a Kreuzeder, Julia |e verfasserin |4 aut | |
| 700 | 1 | |a Guderian, Gernot |e verfasserin |4 aut | |
| 700 | 1 | |a Fasching, Peter A |e verfasserin |4 aut | |
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