BOLERO-2
Trial question
What is the role of everolimus in patients with HR+ advanced breast cancer previously treated with nonsteroidal aromatase inhibitors?
Study design
Multi-center
Double blinded
RCT
Population
724 female patients.
Inclusion criteria: postmenopausal women with HR+ advanced breast cancer previously treated with nonsteroidal aromatase inhibitors.
Key exclusion criteria: HER2-overexpressing patients; only non-measurable lesions other than bone metastasis; receipt of > 1 chemotherapy line for advanced breast cancer; receipt of hormone replacement therapy; radiotherapy within 4 weeks prior to randomization; previous treatment with exemestane or mTOR inhibitors.
Interventions
N=485 everolimus (everolimus 10 mg/day PO plus exemestane 25 mg/day).
N=239 placebo (matching placebo plus exemestane 25 mg/day).
Primary outcome
Median progression-free survival
6.9 months
2.8 months
6.9 months
5.2 months
3.5 months
1.7 months
0.0 months
Everolimus
Placebo
Significant
increase ▲
Significant increase in median progression-free survival (6.9 months vs. 2.8 months; HR 2.33, 95% CI 1.85 to 2.86).
Secondary outcomes
No significant difference in median overall survival (31 months vs. 26.6 months; HR 1.12, 95% CI 0.91 to 1.37).
Significant increase in objective response (9.5% vs. 0.4%; AD 9.1%, 95% CI 3.7 to 14.5).
Safety outcomes
Significant differences in discontinuation due to adverse events (29% vs. 5%), serious adverse events (33% vs. 16%), grade 3-4 adverse events (55% vs. 29%).
Conclusion
In postmenopausal women with HR+ advanced breast cancer previously treated with nonsteroidal aromatase inhibitors, everolimus were superior to placebo with respect to median progression-free survival.
Reference
José Baselga, Mario Campone, Martine Piccart et al. Everolimus in postmenopausal hormone-receptor-positive advanced breast cancer. N Engl J Med. 2012 Feb 9;366(6):520-9.
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