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Everolimus Plus Exemestane in Postmenopausal Patients with HR+ Breast Cancer: BOLERO-2 Final Progression-Free Survival Analysis |
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| Authors: | Denise A. Yardley Shinzaburo Noguchi Kathleen I. Pritchard Howard A. Burris III 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 |
| Affiliation: | 1. Sarah Cannon Research Institute and Tennessee Oncology, PLLC, Nashville, TN, 37203, USA 2. Department of Breast and Endocrine Surgery, Osaka University, Suita, Osaka, 565-0871, Japan 3. Sunnybrook Odette Cancer Centre and the University of Toronto, Toronto, ON, M4N 3M5, Canada 4. Memorial Sloan-Kettering Cancer Center, New York, NY, 10065, USA 5. Department of Surgery, Comprehensive Cancer Center, Medical University of Vienna, 1090, Vienna, Austria 6. The University of Texas MD Anderson Cancer Center, Houston, TX, 77030, USA 7. Institut de Cancérologie de l’Ouest, René Gauducheau, Centre de Recherche en Cancérologie, 44805, Nantes Saint Herblain, France 8. Department of Medical Oncology, Ospedale di Macerata, 62100, Macerata, Italy 9. Institut Jules Bordet, Université Libre de Bruxelles, 1000, Brussels, Belgium 10. Department of Oncology, Palacky University Medical School and Teaching Hospital, 775 20, Olomouc, Czech Republic 11. Masaryk Memorial Cancer Institute, 656 53, Brno, Czech Republic 12. NYU Langone Arena Oncology, P.C., Lake Success, NY, 11042, USA 13. Department of Medical Oncology, Orbis Medical Center, 6162 BG, Sittard-Geleen, The Netherlands 14. Horizon Oncology, Lafayette, IN, 47905, USA 15. Novartis Pharmaceuticals Corporation, East Hanover, NJ, 07936, USA 16. UCSF Helen Diller Family Comprehensive Cancer Center, San Francisco, CA, 94115, USA |
| Abstract: | IntroductionEffective 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.MethodsBOLERO-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.ResultsFinal 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, patients with recurrence during or within 12 months of completion of adjuvant therapy, 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.ConclusionThe 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. |
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