Cited 59 times in
Efficacy of everolimus with exemestane versus exemestane alone in Asian patients with HER2-negative, hormone-receptor-positive breast cancer in BOLERO-2
DC Field | Value | Language |
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dc.contributor.author | 박병우 | - |
dc.date.accessioned | 2018-12-06T16:40:40Z | - |
dc.date.available | 2018-12-06T16:40:40Z | - |
dc.date.issued | 2014 | - |
dc.identifier.issn | 1340-6868 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/166050 | - |
dc.description.abstract | BACKGROUND: The addition of mTOR inhibitor everolimus (EVE) to exemestane (EXE) was evaluated in an international, phase 3 study (BOLERO-2) in patients with hormone-receptor-positive (HR(+)) breast cancer refractory to letrozole or anastrozole. The safety and efficacy of anticancer treatments may be influenced by ethnicity (Sekine et al. in Br J Cancer 99:1757-62, 2008). Safety and efficacy results from Asian versus non-Asian patients in BOLERO-2 are reported. METHODS: Patients were randomized (2:1) to 10 mg/day EVE + EXE or placebo (PBO) + EXE. Primary endpoint was progression-free survival (PFS). Secondary endpoints included overall survival, response rate, clinical benefit rate, and safety. RESULTS: Of 143 Asian patients, 98 received EVE + EXE and 45 received PBO + EXE. Treatment with EVE + EXE significantly improved median PFS versus PBO + EXE among Asian patients by 38 % (HR = 0.62; 95 % CI, 0.41-0.94). Median PFS was also improved among non-Asian patients by 59 % (HR = 0.41; 95 % CI, 0.33-0.50). Median PFS duration among EVE-treated Asian patients was 8.48 versus 4.14 months for PBO + EXE, and 7.33 versus 2.83 months, respectively, in non-Asian patients. The most common grade 3/4 adverse events (stomatitis, anemia, elevated liver enzymes, hyperglycemia, and dyspnea) occurred at similar frequencies in Asian and non-Asian patients. Grade 1/2 interstitial lung disease occurred more frequently in Asian patients. Quality of life was similar between treatment arms in Asian patients. CONCLUSION: Adding EVE to EXE provided substantial clinical benefit in both Asian and non-Asian patients with similar safety profiles. This combination represents an improvement in the management of postmenopausal women with HR(+)/HER2(-) advanced breast cancer progressing on nonsteroidal aromatase inhibitors, regardless of ethnicity. TRIAL REGISTRATION: ClinicalTrials.gov NCT00863655. | - |
dc.description.statementOfResponsibility | open | - |
dc.format | application/pdf | - |
dc.language | English | - |
dc.publisher | Maruzen Co. | - |
dc.relation.isPartOf | BREAST CANCER | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.rights | https://creativecommons.org/licenses/by-nc-nd/2.0/kr/ | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Androstadienes/administration & dosage | - |
dc.subject.MESH | Androstadienes/adverse effects | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols/adverse effects | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols/therapeutic use* | - |
dc.subject.MESH | Asian Continental Ancestry Group | - |
dc.subject.MESH | Breast Neoplasms/drug therapy* | - |
dc.subject.MESH | Breast Neoplasms/metabolism | - |
dc.subject.MESH | Everolimus | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Quality of Life | - |
dc.subject.MESH | Receptor, ErbB-2/metabolism | - |
dc.subject.MESH | Sirolimus/administration & dosage | - |
dc.subject.MESH | Sirolimus/adverse effects | - |
dc.subject.MESH | Sirolimus/analogs & derivatives | - |
dc.subject.MESH | Sirolimus/pharmacology | - |
dc.subject.MESH | TOR Serine-Threonine Kinases/antagonists & inhibitors | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Efficacy of everolimus with exemestane versus exemestane alone in Asian patients with HER2-negative, hormone-receptor-positive breast cancer in BOLERO-2 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Surgery (외과학교실) | - |
dc.contributor.googleauthor | Shinzaburo Noguchi | - |
dc.contributor.googleauthor | Norikazu Masuda | - |
dc.contributor.googleauthor | Hiroji Iwata | - |
dc.contributor.googleauthor | Hirofumi Mukai | - |
dc.contributor.googleauthor | Jun Horiguchi | - |
dc.contributor.googleauthor | Puttisak Puttawibul | - |
dc.contributor.googleauthor | Vichien Srimuninnimit | - |
dc.contributor.googleauthor | Yutaka Tokuda | - |
dc.contributor.googleauthor | Katsumasa Kuroi | - |
dc.contributor.googleauthor | Hirotaka Iwase | - |
dc.contributor.googleauthor | Hideo Inaji | - |
dc.contributor.googleauthor | Shozo Ohsumi | - |
dc.contributor.googleauthor | Woo-Chul Noh | - |
dc.contributor.googleauthor | Takahiro Nakayama | - |
dc.contributor.googleauthor | Shinji Ohno | - |
dc.contributor.googleauthor | Yoshiaki Rai | - |
dc.contributor.googleauthor | Byeong-Woo Park | - |
dc.contributor.googleauthor | Ashok Panneerselvam | - |
dc.contributor.googleauthor | Mona El-Hashimy | - |
dc.contributor.googleauthor | Tetiana Taran | - |
dc.contributor.googleauthor | Tarek Sahmoud | - |
dc.contributor.googleauthor | Yoshinori Ito | - |
dc.identifier.doi | 10.1007/s12282-013-0444-8 | - |
dc.contributor.localId | A01475 | - |
dc.relation.journalcode | J00401 | - |
dc.identifier.eissn | 1880-4233 | - |
dc.identifier.pmid | 23404211 | - |
dc.contributor.alternativeName | Park, Byeong Woo | - |
dc.contributor.affiliatedAuthor | 박병우 | - |
dc.citation.volume | 21 | - |
dc.citation.number | 6 | - |
dc.citation.startPage | 703 | - |
dc.citation.endPage | 714 | - |
dc.identifier.bibliographicCitation | BREAST CANCER, Vol.21(6) : 703-714, 2014 | - |
dc.identifier.rimsid | 59279 | - |
dc.type.rims | ART | - |
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