Breast Cancer Treatment with Everolimus and Exemestane for Er+ Women - Results of the 2Nd Interim Analysis of the Non-Interventional Trial Brawo

Fasching, Peter A.; Decker, Thomas; Schneeweiß, Andreas; Uleer, Christoph; Förster, Frank; Wimberger, Pauline; Kurbacher, C.M.; Harbeck, Nadia; Tomé, Oliver; Müller, Bettina; Mundhenke, Christoph; Kümmel, Sherko; Muth, Mathias; Kreuzeder, Julia; Bloch, Wilhelm; Tesch, Hans; Lüftner, Diana; Jackisch, Christian; Schütz, Florian; Grischke, Eva‐Maria

doi:10.1093/annonc/mdu438.6

Cited by 16 publications

(29 citation statements)

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“…Furthermore, everolimus was also more likely to be used among patients who had received prior chemotherapy for mBC. This was in line with the non-interventional prospective Breast Cancer with Afinitor (for) ER+ Women (BRAWO) study, which showed that a high proportion of everolimus use was preceded by chemotherapy 18 This is probably because of the fact that although the NCCN guidelines included everolimus/exemestane combination therapy as one of recommended endocrine therapy for HR+/HER2-mBC 11 , they are not explicit in terms of how it should be used.…”

Section: Discussionsupporting

confidence: 63%

“…The BRAWO study showed that close to half of patients received the therapy in third line or above among everolimus users in Germany 18 . Notably, late line everolimus was often preceded by the use of chemotherapy: 35% among patients receiving fourth line everolimus, and 63% among patients receiving fifth line everolimus 18 .…”

Section: Discussionmentioning

confidence: 99%

“…Notably, late line everolimus was often preceded by the use of chemotherapy: 35% among patients receiving fourth line everolimus, and 63% among patients receiving fifth line everolimus 18 . While the current study showed that chemotherapy was commonly used in the line following everolimus, there was also a relatively high proportion of chemotherapy preceding everolimus in second line (~15%) and third line or later (~30%), which were similar to the BRAWO study (second line: 11%, third line: 14%) 18 .…”

Section: Discussionmentioning

confidence: 99%

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Everolimus use and associated factors among post-menopausal women with hormonal receptor positive/human epidermal growth factor receptor 2 negative metastatic breast cancer

Hao

Xie

et al. 2015

Current Medical Research and Opinion

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In the real world, everolimus was used in more severe patients than ET but less severe patients than CT based on visceral metastasis, tumor volume, and performance status. The top reason for prescribing everolimus was efficacy. A large proportion of patients received first or second line CT before everolimus initiation. The majority of patients used everolimus according to the labeled combination and dose. Future studies are needed to determine optimal sequencing of everolimus, ET, and CT for HR+/HER2- mBC.

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Section: Discussionsupporting

confidence: 63%

Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

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Everolimus use and associated factors among post-menopausal women with hormonal receptor positive/human epidermal growth factor receptor 2 negative metastatic breast cancer

Hao

Xie

et al. 2015

Current Medical Research and Opinion

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“…BOLERO‐2 was the first phase III trial to show a significant improvement in PFS among postmenopausal women with NSAI‐resistant HR+, HER2− aBC treated with everolimus plus exemestane vs exemestane alone . A subsequent non‐interventional study, BRAWO, collected data on the routine clinical use of everolimus and exemestane in postmenopausal women with HR+, HER2− aBC progressing on or after NSAI therapy . Although studies with different designs and study populations should be compared with caution, the current 4EVER trial results support the previously reported clinical benefits and known safety profile of everolimus plus exemestane.…”

Section: Discussionmentioning

confidence: 99%

Efficacy and safety of everolimus plus exemestane in postmenopausal women with hormone receptor‐positive, human epidermal growth factor receptor 2‐negative locally advanced or metastatic breast cancer: Results of the single‐arm, phase IIIB 4EVER trial

Tesch

Stoetzer²,

Decker

et al. 2018

Intl Journal of Cancer

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In BOLERO-2, adding everolimus to exemestane resulted in a twofold increase in median progression-free survival (PFS) vs exemestane in postmenopausal women with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (aBC) after progression on a non-steroidal aromatase inhibitor (NSAI). Here, we report on the open-label, single-arm, phase IIIB 4EVER trial (NCT01626222). This trial evaluated the clinical effectiveness of everolimus plus exemestane in postmenopausal women with HR+, HER2- aBC who had progressed on or after an NSAI, but with no restrictions on the time of progression after NSAI, prior chemotherapy for advanced disease or previous exemestane. The primary endpoint was overall response rate (ORR; i.e. the percentage of patients with a best overall response of complete or partial response per RECIST 1.1) within the first 24 weeks of treatment. Secondary endpoints included PFS, overall survival, safety and health-related quality of life. Between June 2012 and November 2013, 299 patients were enrolled at 82 German centers: 281 patients were evaluable for efficacy and 299 for safety. The ORR was 8.9% (95% confidence interval [CI]: 5.8-12.9%). Median PFS was 5.6 months (95% CI: 5.4-6.0 months). The most frequent grade 3/4 adverse events were stomatitis (8.4%), general physical health deterioration (6.7%), dyspnea (4.7%) and anemia (4.3%). The ORR in 4EVER was lower than in BOLERO-2, likely due to inclusion of patients with more advanced disease and extensive pretreatment. These data confirm the clinical benefits and known safety profile of everolimus plus exemestane in postmenopausal women with HR+, HER2- aBC.

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“…Interim analyses from a large German non-interventional study (brawo) of 3000 patients with advanced or metastatic hr-positive, her2-negative breast cancer treated with everolimus and exemestane suggest that physician experience, prophylactic measures, and close monitoring of patients can reduce the incidence of stomatitis. Those observations emphasize that proactive communication and management strategies are essential 31,32 .…”

Section: Early Recognition and Frequent Monitoringmentioning

confidence: 99%

Novel Agents and Associated Toxicities of Inhibitors of the PI3K/Akt/mTOR Pathway for the Treatment of Breast Cancer

et al. 2015

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The PI3K/Akt/mTOR (phosphatidylinositol 3 kinase/ Akt/mammalian target of rapamycin) signalling pathway is an established driver of oncogenic activity in human malignancies. Therapeutic targeting of this pathway holds significant promise as a treatment strategy. Everolimus, an mtor inhibitor, is the first of this class of agents approved for the treatment of hormone receptor–positive, human epidermal growth factor receptor 2–negative advanced breast cancer. Everolimus has been associated with significant improvements in progression-free survival; however, it is also associated with increased toxicity related to its specific mechanism of action. Methods: A comprehensive review of the literature conducted using a focused medline search was combined with a search of current trials at http://ClinicalTrials.gov/. Summary tables of the toxicities of the various classes of PI3K/Akt/mTOR inhibitors were created. A broad group of Canadian health care professionals was assembled to review the data and to produce expert opinion and summary recommendations for possible best practices in managing the adverse events associated with these pathway inhibitors. Results: Differing toxicities are associated with the various classes of PI3K/Akt/mTOR pathway inhibitors. The most common unique adverse events observed in everolimus clinical trials in breast cancer include stomatitis (all grades: approximately 60%), noninfectious pneumonitis (15%), rash (40%), hyperglycemia (15%), and immunosuppression (40%). To minimize grades 3 and 4 toxicities and to attempt to attain optimal outcomes, effective management of those adverse events is critical. Management should be interdisciplinary and should use approaches that include education, early recognition, active intervention, and potentially prophylactic strategies. Discussion: Everolimus likely represents the first of many complex oral targeted therapies for the treatment of breast cancer. Using this agent as a template, it is essential to establish best practices involving and integrating multiple disciplines for the management of future PI3K/Akt/mTOR signalling pathway inhibitors.

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Breast Cancer Treatment with Everolimus and Exemestane for Er+ Women - Results of the 2Nd Interim Analysis of the Non-Interventional Trial Brawo

Cited by 16 publications

References 0 publications

Everolimus use and associated factors among post-menopausal women with hormonal receptor positive/human epidermal growth factor receptor 2 negative metastatic breast cancer

Everolimus use and associated factors among post-menopausal women with hormonal receptor positive/human epidermal growth factor receptor 2 negative metastatic breast cancer

Efficacy and safety of everolimus plus exemestane in postmenopausal women with hormone receptor‐positive, human epidermal growth factor receptor 2‐negative locally advanced or metastatic breast cancer: Results of the single‐arm, phase IIIB 4EVER trial

Novel Agents and Associated Toxicities of Inhibitors of the PI3K/Akt/mTOR Pathway for the Treatment of Breast Cancer

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