TY - JOUR
T1 - Effect of visceral metastases on the efficacy and safety of everolimus in postmenopausal women with advanced breast cancer
T2 - Subgroup analysis from the BOLERO-2 study
AU - Campone, Mario
AU - Bachelot, Thomas
AU - Gnant, Michael
AU - Deleu, Ines
AU - Rugo, Hope S.
AU - Pistilli, Barbara
AU - Noguchi, Shinzaburo
AU - Shtivelband, Mikhail
AU - Pritchard, Kathleen I.
AU - Provencher, Louise
AU - Burris, Howard A.
AU - Hart, Lowell
AU - Melichar, Bohuslav
AU - Hortobagyi, Gabriel N.
AU - Arena, Francis
AU - Baselga, José
AU - Panneerselvam, Ashok
AU - Héniquez, Aurelia
AU - El-Hashimyt, Mona
AU - Taran, Tetiana
AU - Sahmoud, Tarek
AU - Piccart, Martine
N1 - Funding Information:
This work was supported by Novartis Pharmaceuticals . Financial support for medical editorial assistance was provided by Novartis Pharmaceuticals. The BOLERO-2 study was designed by the academic investigators and by representatives of the sponsor, Novartis. Academic investigators were responsible for data collection, which was overseen by the IDMC. Data were reviewed by the IDMC before analysis by Novartis statisticians. Novartis employee-authors were involved in the writing of this manuscript; however, Novartis had no role in the decision to submit this manuscript for publication.
PY - 2013/8/1
Y1 - 2013/8/1
N2 - Background Everolimus (EVE; an inhibitor of mammalian target of rapamycin [mTOR]) enhances treatment options for postmenopausal women with hormone-receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (ABC) who progress on a non-steroidal aromatase inhibitor (NSAI). This is especially true for patients with visceral disease, which is associated with poor prognosis. The BOLERO-2 (Breast cancer trial of OraL EveROlimus-2) trial showed that combination treatment with EVE and exemestane (EXE) versus placebo (PBO) + EXE prolonged progression-free survival (PFS) by both investigator (7.8 versus 3.2 months, respectively) and independent (11.0 versus 4.1 months, respectively) central assessment in postmenopausal women with HR+, HER2- ABC recurring/progressing during/after NSAI therapy. The BOLERO-2 trial included a substantial proportion of patients with visceral metastases (56%). Methods Prespecified exploratory subgroup analysis conducted to evaluate the efficacy and safety of EVE + EXE versus PBO + EXE in a prospectively defined subgroup of patients with visceral metastases. Findings At a median follow-up of 18 months, EVE + EXE significantly prolonged median PFS compared with PBO + EXE both in patients with visceral metastases (N = 406; 6.8 versus 2.8 months) and in those without visceral metastases (N = 318; 9.9 versus 4.2 months). Improvements in PFS with EVE + EXE versus PBO + EXE were also observed in patients with visceral metastases regardless of Eastern Cooperative Oncology Group performance status (ECOG PS). Patients with visceral metastases and ECOG PS 0 had a median PFS of 6.8 months with EVE + EXE versus 2.8 months with PBO + EXE. Among patients with visceral metastases and ECOG PS ≥1, EVE + EXE treatment more than tripled median PFS compared with PBO + EXE (6.8 versus 1.5 months). Interpretation Adding EVE to EXE markedly extended PFS by ≥4 months among patients with HR+ HER2- ABC regardless of the presence of visceral metastases. Funding Novartis.
AB - Background Everolimus (EVE; an inhibitor of mammalian target of rapamycin [mTOR]) enhances treatment options for postmenopausal women with hormone-receptor-positive (HR+), human epidermal growth factor receptor-2-negative (HER2-) advanced breast cancer (ABC) who progress on a non-steroidal aromatase inhibitor (NSAI). This is especially true for patients with visceral disease, which is associated with poor prognosis. The BOLERO-2 (Breast cancer trial of OraL EveROlimus-2) trial showed that combination treatment with EVE and exemestane (EXE) versus placebo (PBO) + EXE prolonged progression-free survival (PFS) by both investigator (7.8 versus 3.2 months, respectively) and independent (11.0 versus 4.1 months, respectively) central assessment in postmenopausal women with HR+, HER2- ABC recurring/progressing during/after NSAI therapy. The BOLERO-2 trial included a substantial proportion of patients with visceral metastases (56%). Methods Prespecified exploratory subgroup analysis conducted to evaluate the efficacy and safety of EVE + EXE versus PBO + EXE in a prospectively defined subgroup of patients with visceral metastases. Findings At a median follow-up of 18 months, EVE + EXE significantly prolonged median PFS compared with PBO + EXE both in patients with visceral metastases (N = 406; 6.8 versus 2.8 months) and in those without visceral metastases (N = 318; 9.9 versus 4.2 months). Improvements in PFS with EVE + EXE versus PBO + EXE were also observed in patients with visceral metastases regardless of Eastern Cooperative Oncology Group performance status (ECOG PS). Patients with visceral metastases and ECOG PS 0 had a median PFS of 6.8 months with EVE + EXE versus 2.8 months with PBO + EXE. Among patients with visceral metastases and ECOG PS ≥1, EVE + EXE treatment more than tripled median PFS compared with PBO + EXE (6.8 versus 1.5 months). Interpretation Adding EVE to EXE markedly extended PFS by ≥4 months among patients with HR+ HER2- ABC regardless of the presence of visceral metastases. Funding Novartis.
KW - Advanced breast cancer
KW - Everolimus
KW - Exemestane
KW - Visceral metastases
UR - http://www.scopus.com/inward/record.url?scp=84879914608&partnerID=8YFLogxK
U2 - 10.1016/j.ejca.2013.04.011
DO - 10.1016/j.ejca.2013.04.011
M3 - Article
C2 - 23735704
AN - SCOPUS:84879914608
SN - 0959-8049
VL - 49
SP - 2621
EP - 2632
JO - European Journal of Cancer
JF - European Journal of Cancer
IS - 12
ER -