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Safety and efficacy of everolimus (EVE) plus exemestane (EXE) in postmenopausal women with locally advanced or metastatic breast cancer: final results from EVEREXES

Authors
 Young-Hyuck Im  ;  Bulent Karabulut  ;  Keun Seok Lee  ;  Byeong-Woo Park  ;  Aditya Adhav  ;  Havva Yesil Cinkir  ;  Hikmat Abdel-Razeq  ;  Yuan-Ching Chang  ;  Sercan Aksoy  ;  Seock-Ah Im  ;  Joon Jeong  ;  Yeesoo Chae  ;  James Bowles  ;  Khemaies Slimane  ;  Hongling Xue  ;  Sung-Bae Kim 
Citation
 BREAST CANCER RESEARCH AND TREATMENT, Vol.188(1) : 77-89, 2021-07 
Journal Title
BREAST CANCER RESEARCH AND TREATMENT
ISSN
 0167-6806 
Issue Date
2021-07
MeSH
Androstadienes / therapeutic use ; Antineoplastic Combined Chemotherapy Protocols ; Asia ; Breast Neoplasms* / drug therapy ; Everolimus* / therapeutic use ; Female ; Humans ; Neoplasm Recurrence, Local / drug therapy ; Postmenopause ; Receptor, ErbB-2 ; Sirolimus / therapeutic use
Keywords
Breast Cancer ; EVEREXES ; Everolimus ; Exemestane ; HER2 − ; HR + ; Mammalian target of rapamycin (mTOR)
Abstract
Background: This study was conducted to collect clinical safety, tolerability, and efficacy data with the use of everolimus (EVE) combined with exemestane (EXE) in patients with advanced breast cancer (ABC).

Methods: The EVEREXES trial initiated in 2012, provided early access to the first dual blockade treatment with EVE + EXE in patients with HR+, HER2 - ABC in Asia and other emerging growth countries. Postmenopausal women with HR+, HER2 - ABC who had documented recurrence or progression, following a nonsteroidal aromatase inhibitor therapy, were treated with EVE (10 mg/day) + EXE (25 mg/day) orally.

Results: A total of 235 patients received ≥ 1 dose of study medication. At the end of the study, all patients ceased the treatment. Disease progression (66.0%) was the primary reason of discontinuation. The most common AEs (≥ 20%) were stomatitis, decreased appetite, hyperglycemia, rash, aspartate aminotransferase increased, anemia, alanine aminotransferase increased, cough, and fatigue. No new safety concerns were identified in the current study. Median progression-free survival (PFS) in the Asian subset was similar to that of the overall population (9.3 months in both groups). Confirmed overall response rate (ORR) was achieved for 19.6% of the patients. Efficacy of EVE + EXE across subgroups (prior CT, line of treatment, and presence of visceral metastases) was maintained.

Conclusion: The safety and efficacy results from EVEREXES trial are consistent to data previously reported in BOLERO-2. These results support that EVE + EXE could be a viable treatment option for the postmenopausal women with HR+, HER2 - ABC in Asian region.
Full Text
https://link.springer.com/article/10.1007/s10549-021-06173-z
DOI
10.1007/s10549-021-06173-z
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Surgery (외과학교실) > 1. Journal Papers
Yonsei Authors
Park, Byeong Woo(박병우) ORCID logo https://orcid.org/0000-0003-1353-2607
Jeong, Joon(정준) ORCID logo https://orcid.org/0000-0003-0397-0005
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/184244
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