Everolimus plus exemestane as first-line therapy in HR , HER2− advanced breast cancer in BOLERO-2Report as inadecuate

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Breast Cancer Research and Treatment

, Volume 143, Issue 3, pp 459–467

First Online: 21 December 2013Received: 04 December 2013Accepted: 06 December 2013DOI: 10.1007-s10549-013-2814-5

Cite this article as: Beck, J.T., Hortobagyi, G.N., Campone, M. et al. Breast Cancer Res Treat 2014 143: 459. doi:10.1007-s10549-013-2814-5


The present exploratory analysis examined the efficacy, safety, and quality-of-life effects of everolimus EVE + exemestane EXE in the subgroup of patients in BOLERO-2 whose last treatment before study entry was in the neoadjuvant setting. In BOLERO-2, patients with hormone-receptor-positive HR, human epidermal growth factor receptor-2-negative HER2 advanced breast cancer recurring-progressing after a nonsteroidal aromatase inhibitor NSAI were randomly assigned 2:1 to receive EVE 10 mg-day + EXE 25 mg-day or placebo PBO + EXE. The primary endpoint was progression-free survival PFS by local assessment. Overall, 137 patients received first-line EVE + EXE n = 100 or PBO + EXE n = 37. Median PFS by local investigator assessment nearly tripled to 11.5 months with EVE + EXE from 4.1 months with PBO + EXE hazard ratio = 0.39; 95 % CI 0.25–0.62, while maintaining quality of life. This was confirmed by central assessment 15.2 vs 4.2 months; hazard ratio = 0.32; 95 % CI 0.18–0.57. The marked PFS improvement in patients receiving EVE + EXE as first-line therapy for disease recurrence during or after neoadjuvant NSAI therapy supports the efficacy of this combination in the first-line setting. Furthermore, the results highlight the potential benefit of early introduction of EVE + EXE in the management of HR, HER2 advanced breast cancer in postmenopausal patients.

KeywordsBOLERO-2 Breast cancer Everolimus First-line therapy Metastatic disease mTOR inhibition AbbreviationsABC11st International Consensus Conference for Advanced Breast Cancer

AEAdverse event

AGOArbeitsgemeinschaft Gynäkologische Onkologie e.V

AIAromatase inhibitor

AKTProtein kinase B


CIConfidence interval

ECOGEastern Cooperative Oncology Group

ESMOEuropean Society for Medical Oncology



HER2Human epidermal growth factor receptor-2-negative


HRHazard ratio


HRQoLHealth-related quality of life

LHRHaLuteinizing hormone-releasing hormone analogue

mTORMammalian target of rapamycin

NCCNNational Comprehensive Cancer Network

NSAINonsteroidal aromatase inhibitor


PFSProgression-free survival

PI3KPhosphatidylinositol 3-kinase

RECISTResponse Evaluation Criteria in Solid Tumors

TDDTime to definitive deterioration

TTPTime to progression

Presented in part at: The St. Gallen International Breast Cancer Conference SGBCC, March 13–16, 2013, St. Gallen, Switzerland. The American Society of Clinical Oncology ASCO, May 31–June 04, 2013, Chicago, IL, USA. The European Society for Medical Oncology ESMO, September 27–October 01, 2013, Amsterdam, The Netherlands.

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Author: J. Thaddeus Beck - Gabriel N. Hortobagyi - Mario Campone - Fabienne Lebrun - Ines Deleu - Hope S. Rugo - Barbara Pistill

Source: https://link.springer.com/

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