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
DC Field | Value | Language |
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dc.contributor.author | Jeong, Hyehyun | - |
dc.contributor.author | Jeong, Jae Ho | - |
dc.contributor.author | Kim, Jeong Eun | - |
dc.contributor.author | Ahn, Jin-Hee | - |
dc.contributor.author | Jung, Kyung Hae | - |
dc.contributor.author | Koh, Su-Jin | - |
dc.contributor.author | Cheon, Jaekyung | - |
dc.contributor.author | Sohn, Joohyuk | - |
dc.contributor.author | Kim, Gun Min | - |
dc.contributor.author | Lee, Keun Seok | - |
dc.contributor.author | Sim, Sung Hoon | - |
dc.contributor.author | Park, In Hae | - |
dc.contributor.author | Kim, Sung-Bae | - |
dc.date.accessioned | 2022-02-25T09:41:38Z | - |
dc.date.available | 2022-02-25T09:41:38Z | - |
dc.date.created | 2021-12-07 | - |
dc.date.issued | 2021-08-15 | - |
dc.identifier.issn | 0020-7136 | - |
dc.identifier.uri | https://scholar.korea.ac.kr/handle/2021.sw.korea/136848 | - |
dc.description.abstract | The 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.language | English | - |
dc.language.iso | en | - |
dc.publisher | WILEY | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.affiliatedAuthor | Park, In Hae | - |
dc.identifier.doi | 10.1002/ijc.33613 | - |
dc.identifier.scopusid | 2-s2.0-85105617531 | - |
dc.identifier.wosid | 000647926600001 | - |
dc.identifier.bibliographicCitation | INTERNATIONAL JOURNAL OF CANCER, v.149, no.4, pp.917 - 924 | - |
dc.relation.isPartOf | INTERNATIONAL JOURNAL OF CANCER | - |
dc.citation.title | INTERNATIONAL JOURNAL OF CANCER | - |
dc.citation.volume | 149 | - |
dc.citation.number | 4 | - |
dc.citation.startPage | 917 | - |
dc.citation.endPage | 924 | - |
dc.type.rims | ART | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.description.journalRegisteredClass | scie | - |
dc.description.journalRegisteredClass | scopus | - |
dc.relation.journalResearchArea | Oncology | - |
dc.relation.journalWebOfScienceCategory | Oncology | - |
dc.subject.keywordAuthor | bone turnover markers | - |
dc.subject.keywordAuthor | breast cancer | - |
dc.subject.keywordAuthor | everolimus | - |
dc.subject.keywordAuthor | hormone receptor& | - |
dc.subject.keywordAuthor | #8208 | - |
dc.subject.keywordAuthor | positive | - |
dc.subject.keywordAuthor | premenopausal women | - |
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