TY - JOUR
T1 - Everolimus plus exemestane in postmenopausal patients with HR+ breast cancer
T2 - BOLERO-2 final progression-free survival analysis
AU - Yardley, Denise A.
AU - Noguchi, Shinzaburo
AU - Pritchard, Kathleen I.
AU - Burris, Howard A.
AU - Baselga, José
AU - Gnant, Michael
AU - Hortobagyi, Gabriel N.
AU - Campone, Mario
AU - Pistilli, Barbara
AU - Piccart, Martine
AU - Melichar, Bohuslav
AU - Petrakova, Katarina
AU - Arena, Francis P.
AU - Erdkamp, Frans
AU - Harb, Wael A.
AU - Feng, Wentao
AU - Cahana, Ayelet
AU - Taran, Tetiana
AU - Lebwohl, David
AU - Rugo, Hope S.
N1 - Funding Information:
Sponsorship and article processing charges for this study were funded by Novartis. We thank the patients who participated in the BOLERO-2 trial and the investigators, study nurses, and clinical research associates from the individual trial centers who provided ongoing support. Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals. We thank Jerome F Sah, PhD, ProEd Communications, Inc., for his medical editorial assistance with this manuscript. Dr.
PY - 2013/1/1
Y1 - 2013/1/1
N2 - 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, 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. 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.
AB - 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, 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. 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.
KW - Advanced breast cancer
KW - Everolimus
KW - Exemestane
KW - Hormone receptor positive
KW - Nonsteroidal aromatase inhibitors
KW - Oncology
KW - Postmenopausal
KW - Progression-free survival
UR - http://www.scopus.com/inward/record.url?scp=84889654398&partnerID=8YFLogxK
U2 - 10.1007/s12325-013-0060-1
DO - 10.1007/s12325-013-0060-1
M3 - Article
C2 - 24158787
AN - SCOPUS:84889654398
SN - 0741-238X
VL - 30
SP - 870
EP - 884
JO - Advances in Therapy
JF - Advances in Therapy
IS - 10
ER -