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Ann Oncol. 2014 Dec;25(12):2357-62. doi: 10.1093/annonc/mdu456. Epub 2014 Sep 17.

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

Author information

1
Department of Medicine, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium martine.piccart@bordet.be.
2
Department of Breast Medical Oncology, Multidisciplinary Breast Cancer Research Program, University of Texas MD Anderson Cancer Center, Houston, USA.
3
Institut de Cancérologie de l'Ouest, René Gauducheau, Centre de Recherche en Cancérologie, Nantes Saint Herblain, France.
4
Department of Medicine, Sunnybrook Odette Cancer Centre and the University of Toronto, Toronto, Canada.
5
Department of Medicine, Institut Jules Bordet, Université Libre de Bruxelles, Brussels, Belgium.
6
Department of Breast Medical Oncology, Cancer Institute Hospital, Japanese Foundation for Cancer Research, Tokyo.
7
Department of Breast and Endocrine Surgery, Osaka University Graduate School of Medicine, Osaka, Japan.
8
Breast Cancer Centers, Memorial Cancer Institute, Hollywood.
9
Breast Oncology and Clinical Trials Education, University of California, San Francisco Helen Diller Family Comprehensive Cancer Center, San Francisco, USA.
10
Oncologic Centre, AZ Nikolaas, Sint-Niklaas, Belgium.
11
Sarah Cannon Research Institute, Nashville, USA.
12
Centre des Maladies du Sein Deschênes-Fabia, CHU-Hôpital du Saint Sacrement, Québec, Canada.
13
Multidisciplinary Breast Centre and Department of Gynecologic Oncology, University Hospitals Leuven, Leuven, Belgium.
14
Department of Surgery, Comprehensive Cancer Center Vienna, Medical University of Vienna, Vienna, Austria.
15
Ironwood Cancer & Research Centers, Chandler.
16
Novartis Pharmaceuticals Corporation, East Hanover.
17
Memorial Sloan-Kettering Cancer Center, New York, USA.

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.

KEYWORDS:

everolimus; exemestane; hormone-receptor-positive breast cancer; overall survival

PMID:
25231953
PMCID:
PMC6267855
DOI:
10.1093/annonc/mdu456
[Indexed for MEDLINE]
Free PMC Article

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