Unknown

Dataset Information

0

Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2†.


ABSTRACT: BACKGROUND:The BOLERO-2 study previously demonstrated that adding everolimus (EVE) to exemestane (EXE) significantly improved progression-free survival (PFS) by more than twofold in patients with hormone-receptor-positive (HR(+)), HER2-negative advanced breast cancer that recurred or progressed during/after treatment with nonsteroidal aromatase inhibitors (NSAIs). The overall survival (OS) analysis is presented here. PATIENTS AND METHODS:BOLERO-2 is a phase III, double-blind, randomized international trial comparing EVE 10 mg/day plus EXE 25 mg/day versus placebo (PBO) + EXE 25 mg/day in postmenopausal women with HR(+) advanced breast cancer with prior exposure to NSAIs. The primary end point was PFS by local investigator assessment; OS was a key secondary end point. RESULTS:At the time of data cutoff (3 October 2013), 410 deaths had occurred and 13 patients remained on treatment. Median OS in patients receiving EVE + EXE was 31.0 months [95% confidence interval (CI) 28.0-34.6 months] compared with 26.6 months (95% CI 22.6-33.1 months) in patients receiving PBO + EXE (hazard ratio = 0.89; 95% CI 0.73-1.10; log-rank P = 0.14). Poststudy treatments were received by 84% of patients in the EVE + EXE arm versus 90% of patients in the PBO + EXE arm. Types of poststudy therapies were balanced across arms, except for chemotherapy (53% EVE + EXE versus 63% PBO + EXE). No new safety concerns were identified. CONCLUSIONS:In BOLERO-2, adding EVE to EXE did not confer a statistically significant improvement in the secondary end point OS despite producing a clinically meaningful and statistically significant improvement in the primary end point, PFS (4.6-months prolongation in median PFS; P < 0.0001). Ongoing translational research should further refine the benefit of mTOR inhibition and related pathways in this treatment setting. TRIAL REGISTRATION NUMBER:NCT00863655.

SUBMITTER: Piccart M 

PROVIDER: S-EPMC6267855 | biostudies-literature | 2014 Dec

REPOSITORIES: biostudies-literature

altmetric image

Publications

Everolimus plus exemestane for hormone-receptor-positive, human epidermal growth factor receptor-2-negative advanced breast cancer: overall survival results from BOLERO-2†.

Piccart M M   Hortobagyi G N GN   Campone M M   Pritchard K I KI   Lebrun F F   Ito Y Y   Noguchi S S   Perez A A   Rugo H S HS   Deleu I I   Burris H A HA   Provencher L L   Neven P P   Gnant M M   Shtivelband M M   Wu C C   Fan J J   Feng W W   Taran T T   Baselga J J  

Annals of oncology : official journal of the European Society for Medical Oncology 20140917 12


<h4>Background</h4>The BOLERO-2 study previously demonstrated that adding everolimus (EVE) to exemestane (EXE) significantly improved progression-free survival (PFS) by more than twofold in patients with hormone-receptor-positive (HR(+)), HER2-negative advanced breast cancer that recurred or progressed during/after treatment with nonsteroidal aromatase inhibitors (NSAIs). The overall survival (OS) analysis is presented here.<h4>Patients and methods</h4>BOLERO-2 is a phase III, double-blind, rand  ...[more]

Similar Datasets

| S-EPMC6656445 | biostudies-literature
| S-EPMC6233772 | biostudies-literature
| S-EPMC4210660 | biostudies-literature
| S-EPMC3907668 | biostudies-literature
| S-EPMC5070556 | biostudies-literature
| S-EPMC3898123 | biostudies-literature
| S-EPMC6587781 | biostudies-literature
| S-EPMC3889833 | biostudies-other
| S-EPMC5885212 | biostudies-literature
| S-EPMC7811234 | biostudies-literature