Everolimus Plus Exemestane in Postmenopausal Patients with HR+ Breast Cancer: BOLERO-2 Final Progression-Free Survival Analysis View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2013-10

AUTHORS

Denise A. Yardley, Shinzaburo Noguchi, Kathleen I. Pritchard, Howard A. Burris, José Baselga, Michael Gnant, Gabriel N. Hortobagyi, Mario Campone, Barbara Pistilli, Martine Piccart, Bohuslav Melichar, Katarina Petrakova, Francis P. Arena, Frans Erdkamp, Wael A. Harb, Wentao Feng, Ayelet Cahana, Tetiana Taran, David Lebwohl, Hope S. Rugo

ABSTRACT

INTRODUCTION: Effective treatments for hormone-receptor-positive (HR(+)) breast cancer (BC) following relapse/progression on nonsteroidal aromatase inhibitor (NSAI) therapy are needed. Initial Breast Cancer Trials of OraL EveROlimus-2 (BOLERO-2) trial data demonstrated that everolimus and exemestane significantly prolonged progression-free survival (PFS) versus placebo plus exemestane alone in this patient population. METHODS: BOLERO-2 is a phase 3, double-blind, randomized, international trial comparing everolimus (10 mg/day) plus exemestane (25 mg/day) versus placebo plus exemestane in postmenopausal women with HR(+) advanced BC with recurrence/progression during or after NSAIs. The primary endpoint was PFS by local investigator review, and was confirmed by independent central radiology review. Overall survival, response rate, and clinical benefit rate were secondary endpoints. RESULTS: Final study results with median 18-month follow-up show that median PFS remained significantly longer with everolimus plus exemestane versus placebo plus exemestane [investigator review: 7.8 versus 3.2 months, respectively; hazard ratio = 0.45 (95% confidence interval 0.38-0.54); log-rank P < 0.0001; central review: 11.0 versus 4.1 months, respectively; hazard ratio = 0.38 (95% confidence interval 0.31-0.48); log-rank P < 0.0001] in the overall population and in all prospectively defined subgroups, including patients with visceral metastases, [corrected] and irrespective of age. The incidence and severity of adverse events were consistent with those reported at the interim analysis and in other everolimus trials. CONCLUSION: The addition of everolimus to exemestane markedly prolonged PFS in patients with HR(+) advanced BC with disease recurrence/progression following prior NSAIs. These results further support the use of everolimus plus exemestane in this patient population. ClinicalTrials.gov #NCT00863655. More... »

PAGES

870-884

Identifiers

URI

http://scigraph.springernature.com/pub.10.1007/s12325-013-0060-1

DOI

http://dx.doi.org/10.1007/s12325-013-0060-1

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1016141409

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/24158787


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