17 Oct Combination Everolimus/Exemestane For ER+|HER2- Advanced Breast Cancer
MedicalResearch.com Interview with:
Melanie Royce, MD, PhD
Professor of Medicine
University of New Mexico School of Medicine
Director of the Breast Multidisciplinary Clinic and Program
UNM Cancer Center.
MedicalResearch.com: What is the background for this study? What are the main findings?
Response: BOLERO-4 is an open label, single-arm, Phase II study that evaluates the combination of everolimus plus letrozole as a first-line treatment for hormone receptor (HR)-positive/HER2-negative advanced breast cancer patients, as well as the use of everolimus plus exemestane beyond initial progression.
Results of the Phase II BOLERO-4 clinical trial, presented as an oral presentation at the 2016 European Society for Medical Oncology (ESMO) annual meeting, show preliminary evidence that everolimus in combination with letrozole is effective in treating women with HR-positive/HER2-negative advanced breast cancer in the first-line setting. With follow up of 17.5 months, the median progression-free survival (PFS) is not yet reached. At six months, 83.6% (95% CI: 77.3-88.2%) of women taking everolimus plus letrozole in the first-line setting were without disease progression, and 71.4% (95% CI: 64.0%-77.5%) did not have disease progression at twelve months.
Safety findings from BOLERO-4 are consistent with previous studies of everolimus in advanced breast cancer, with the most common adverse events being stomatitis (67.8%), weight loss (42.6%) and diarrhea (36.1%). These adverse events were mostly grade 1 or 2 in severity1.
MedicalResearch.com: What should readers take away from your report?
Response: Preliminary results from the BOLERO-4 study add to the growing body of evidence for targeted combination therapy strategies in HR-positive/HER2-negative advanced breast cancer in the first-line setting. While BOLERO-4 is a hypothesis generating, open-label, Phase II study, the results confirm that combination treatment with mTOR inhibition and endocrine therapy is a reasonable treatment option for women with HR+ advanced breast cancer regardless of progression on prior aromatase inhibitor treatment1. This is especially true for women who may not have access to combination therapy with a CDK4/6 inhibitor in their country. It is important for women to have options when considering treatment for advanced breast cancer and to work with their physicians to determine which option is most appropriate for them.
MedicalResearch.com: What recommendations do you have for future research as a result of this study?
Response: The BOLERO-4 study is ongoing, so we look forward to seeing additional results, including second-line PFS, overall survival and stomatitis sub-analyses.
MedicalResearch.com: Is there anything else you would like to add?
Response: Similar to BOLERO-2, the most common adverse event associated with mTOR inhibition in BOLERO-4 was stomatitis (mouth sores). In BOLERO-4, the incidence of stomatitis was primarily grade 1 or 2, with only 6.4% being grade 3 and 0% grade 41. Additional studies have shown that stomatitis can be significantly minimized or prevented making this treatment option more tolerable2.
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1. Royce M, Villanueva C, Ozguroglu M, et al. BOLERO-4: Phase 2 trial of first-line everolimus (EVE) plus letrozole (LET) in estrogen receptor-positive (ER+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer (BC). Presented at the European Society for Medical Oncology (ESMO) Congress, October 8, 2016, Copenhagen, Denmark (abstract # 2220)
2. Rugo et al. Prevention of everolimus/exemestane (EVE/EXE) stomatitis in postmenopausal (PM) women with hormone receptor-positive (HR+) metastatic breast cancer (MBC) using a dexamethasone-based mouthwash (MW): Results of the SWISH trial. 2016 ASCO Annual Meeting. Poster Presentation Abstract #525. Presented June 5, 2016.
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