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Final results of the randomized phase 2 LEO trial and bone protective effects of everolimus for premenopausal hormone receptor-positive, HER2-negative metastatic breast cancer

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dc.contributor.author손주혁-
dc.contributor.author김건민-
dc.date.accessioned2022-11-24T00:35:57Z-
dc.date.available2022-11-24T00:35:57Z-
dc.date.issued2021-08-
dc.identifier.issn0020-7136-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/190802-
dc.description.abstractThe phase 2 LEO study showed that everolimus (EVE) plus letrozole (LET) with ovarian suppression increased progression-free survival (PFS) in tamoxifen-exposed premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer with visceral metastases. Here we report final survival outcomes from the LEO study, and the results of exploratory analyses of bone turnover marker changes and bone-specific progressive disease. Patients who were exposed to or progressed on tamoxifen as adjuvant/palliative treatments were randomly assigned (2:1) to the EVE (leuprorelin + LET + EVE, n = 92) or LET (leuprorelin + LET, n = 45) arm. In a median 51-months of follow-up, the median PFS was 17.5 and 13.8 months in the EVE and LET arms, respectively (P = .245). Patients in the EVE arm with baseline visceral (median PFS 16.4 vs 9.5 months, P = .040) and bone (median PFS 17.1 vs 10.9, P = .003) metastases had greater PFS compared to the LET arm. No differences in overall survival (OS) were observed (median OS, 48.3 vs 50.8 months, P = .948). The 1-year cumulative incidences of bone-specific disease progression were 6.0% and 23.4% in the EVE and LET arms, respectively (hazard ratio 0.26, P < .001). Bone turnover markers at 6 and 12 weeks after treatment decreased in the EVE arm but were increased or stationary in the LET arm. Skeletal-related events occurred in 6.5% and 11.1% of patients in the EVE and LET arms, respectively. EVE + LET with ovarian suppression prolonged PFS in patients with baseline visceral or bone metastases and offered bone-protective effects in the overall study population. However, these clinical benefits did not translate into an OS benefit.-
dc.description.statementOfResponsibilityopen-
dc.formatapplication/pdf-
dc.languageEnglish-
dc.publisherWiley-Liss-
dc.relation.isPartOfINTERNATIONAL JOURNAL OF CANCER-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.titleFinal results of the randomized phase 2 LEO trial and bone protective effects of everolimus for premenopausal hormone receptor-positive, HER2-negative metastatic breast cancer-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorHyehyun Jeong-
dc.contributor.googleauthorJae Ho Jeong-
dc.contributor.googleauthorJeong Eun Kim-
dc.contributor.googleauthorJin-Hee Ahn-
dc.contributor.googleauthorKyung Hae Jung-
dc.contributor.googleauthorSu-Jin Koh-
dc.contributor.googleauthorJaekyung Cheon-
dc.contributor.googleauthorJoohyuk Sohn-
dc.contributor.googleauthorGun Min Kim-
dc.contributor.googleauthorKeun Seok Lee-
dc.contributor.googleauthorSung Hoon Sim-
dc.contributor.googleauthorIn Hae Park-
dc.contributor.googleauthorSung-Bae Kim-
dc.identifier.doi10.1002/ijc.33613-
dc.contributor.localIdA01995-
dc.contributor.localIdA00287-
dc.relation.journalcodeJ01092-
dc.identifier.eissn1097-0215-
dc.identifier.pmid33905134-
dc.subject.keywordbone turnover markers-
dc.subject.keywordbreast cancer-
dc.subject.keywordeverolimus-
dc.subject.keywordhormone receptor-positive-
dc.subject.keywordpremenopausal women-
dc.contributor.alternativeNameSohn, Joo Hyuk-
dc.contributor.affiliatedAuthor손주혁-
dc.contributor.affiliatedAuthor김건민-
dc.citation.volume149-
dc.citation.number4-
dc.citation.startPage917-
dc.citation.endPage924-
dc.identifier.bibliographicCitationINTERNATIONAL JOURNAL OF CANCER, Vol.149(4) : 917-924, 2021-08-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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