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Leuprorelin combined with letrozole with/without everolimus in ovarian-suppressed premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer: The LEO study

DC Field Value Language
dc.contributor.author김건민-
dc.contributor.author손주혁-
dc.date.accessioned2022-09-14T01:14:20Z-
dc.date.available2022-09-14T01:14:20Z-
dc.date.issued2021-02-
dc.identifier.issn0959-8049-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/190361-
dc.description.abstractPurpose: In the randomised phase II LEO trial, we investigated the effect of adding everolimus (EVE) to letrozole (LET) in ovarian-suppressed premenopausal women with hormone receptor-positive (HR+), HER2-negative (HER2-) recurrent/metastatic breast cancer. Methods: Patients with progression or prior exposure to tamoxifen with or without gonadotropin-releasing hormone agonists, either sequentially or concurrently, in adjuvant or metastatic setting were randomly assigned (2:1) to the EVE arm (leuprorelin + LET + EVE) or the LET arm (leuprorelin + LET) until disease progression or unacceptable toxicity. The primary end-point was progression-free survival (PFS). Secondary end-points included overall survival (OS), objective response rate (ORR), clinical benefit rate (CBR) and safety. Results: Between January 2014 and October 2018, 137 patients were enrolled (median age, 44 years [range, 24-56]). Of them, 75% had endocrine-sensitive disease, and 61% had visceral metastasis. With the median follow-up of 32.4 months, the median PFS was 18.1 months in the EVE arm and 13.8 months in the LET arm (HR 0.73, P = 0.137). Among patients with visceral metastases, the median PFS was significantly longer in the EVE arm (16.4 versus 9.5 months, P = 0.048). The median OS was not reached in both arms. The CBR was significantly higher in the EVE arm (83% versus 62%, P = 0.010). The ORR was similar between the two arms. The most common grade 3/4 adverse events in the EVE arm were neutropenia, alanine aminotransferase elevation and anaemia. Conclusions: EVE plus LET with ovarian-suppression resulted in longer PFS in tamoxifen-exposed HR+, HER2- metastatic breast cancer patients with visceral metastasis.-
dc.description.statementOfResponsibilityrestriction-
dc.languageEnglish-
dc.publisherElsevier Science Ltd-
dc.relation.isPartOfEUROPEAN JOURNAL OF CANCER-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAdult-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols / therapeutic use*-
dc.subject.MESHBreast Neoplasms / drug therapy*-
dc.subject.MESHBreast Neoplasms / metabolism-
dc.subject.MESHBreast Neoplasms / pathology-
dc.subject.MESHEverolimus / administration & dosage-
dc.subject.MESHFemale-
dc.subject.MESHFollow-Up Studies-
dc.subject.MESHGonadotropin-Releasing Hormone / agonists-
dc.subject.MESHHumans-
dc.subject.MESHLetrozole / administration & dosage-
dc.subject.MESHLeuprolide / administration & dosage-
dc.subject.MESHMiddle Aged-
dc.subject.MESHNeoplasm Metastasis-
dc.subject.MESHNeoplasm Recurrence, Local / drug therapy*-
dc.subject.MESHNeoplasm Recurrence, Local / metabolism-
dc.subject.MESHNeoplasm Recurrence, Local / pathology-
dc.subject.MESHPremenopause-
dc.subject.MESHPrimary Ovarian Insufficiency / drug therapy*-
dc.subject.MESHPrimary Ovarian Insufficiency / pathology-
dc.subject.MESHPrognosis-
dc.subject.MESHReceptor, ErbB-2 / metabolism*-
dc.subject.MESHReceptors, Estrogen / metabolism*-
dc.subject.MESHReceptors, Progesterone / metabolism*-
dc.subject.MESHSurvival Rate-
dc.subject.MESHTamoxifen / administration & dosage-
dc.subject.MESHYoung Adult-
dc.titleLeuprorelin combined with letrozole with/without everolimus in ovarian-suppressed premenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer: The LEO study-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
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.doi10.1016/j.ejca.2020.11.044-
dc.contributor.localIdA00287-
dc.contributor.localIdA01995-
dc.relation.journalcodeJ00809-
dc.identifier.eissn1879-0852-
dc.identifier.pmid33388491-
dc.identifier.urlhttps://www.sciencedirect.com/science/article/pii/S0959804920314106-
dc.subject.keywordBreast cancer-
dc.subject.keywordEverolimus-
dc.subject.keywordHormone receptor-positive-
dc.subject.keywordPremenopausal women-
dc.contributor.alternativeNameKim, Gun Min-
dc.contributor.affiliatedAuthor김건민-
dc.contributor.affiliatedAuthor손주혁-
dc.citation.volume144-
dc.citation.startPage341-
dc.citation.endPage350-
dc.identifier.bibliographicCitationEUROPEAN JOURNAL OF CANCER, Vol.144 : 341-350, 2021-02-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers

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