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Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study

DC Field Value Language
dc.contributor.author손주혁-
dc.contributor.author박중현-
dc.contributor.author조한얼-
dc.date.accessioned2022-09-14T01:55:57Z-
dc.date.available2022-09-14T01:55:57Z-
dc.date.issued2021-12-
dc.identifier.issn0923-7534-
dc.identifier.urihttps://ir.ymlib.yonsei.ac.kr/handle/22282913/190674-
dc.description.abstractBackground: Adjuvant abemaciclib combined with endocrine therapy (ET) previously demonstrated clinically meaningful improvement in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) in hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer at the second interim analysis, however follow-up was limited. Here, we present results of the prespecified primary outcome analysis and an additional follow-up analysis. Patients and methods: This global, phase III, open-label trial randomized (1 : 1) 5637 patients to adjuvant ET for ≥5 years ± abemaciclib for 2 years. Cohort 1 enrolled patients with ≥4 positive axillary lymph nodes (ALNs), or 1-3 positive ALNs and either grade 3 disease or tumor ≥5 cm. Cohort 2 enrolled patients with 1-3 positive ALNs and centrally determined high Ki-67 index (≥20%). The primary endpoint was IDFS in the intent-to-treat population (cohorts 1 and 2). Secondary endpoints were IDFS in patients with high Ki-67, DRFS, overall survival, and safety. Results: At the primary outcome analysis, with 19 months median follow-up time, abemaciclib + ET resulted in a 29% reduction in the risk of developing an IDFS event [hazard ratio (HR) = 0.71, 95% confidence interval (CI) 0.58-0.87; nominal P = 0.0009]. At the additional follow-up analysis, with 27 months median follow-up and 90% of patients off treatment, IDFS (HR = 0.70, 95% CI 0.59-0.82; nominal P < 0.0001) and DRFS (HR = 0.69, 95% CI 0.57-0.83; nominal P < 0.0001) benefit was maintained. The absolute improvements in 3-year IDFS and DRFS rates were 5.4% and 4.2%, respectively. Whereas Ki-67 index was prognostic, abemaciclib benefit was consistent regardless of Ki-67 index. Safety data were consistent with the known abemaciclib risk profile. Conclusion: Abemaciclib + ET significantly improved IDFS in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer, with an acceptable safety profile. Ki-67 index was prognostic, but abemaciclib benefit was observed regardless of Ki-67 index. Overall, the robust treatment benefit of abemaciclib extended beyond the 2-year treatment period.-
dc.description.statementOfResponsibilityopen-
dc.languageEnglish-
dc.publisherOxford University Press-
dc.relation.isPartOfANNALS OF ONCOLOGY-
dc.rightsCC BY-NC-ND 2.0 KR-
dc.subject.MESHAminopyridines-
dc.subject.MESHAntineoplastic Combined Chemotherapy Protocols / therapeutic use-
dc.subject.MESHBenzimidazoles-
dc.subject.MESHBreast Neoplasms* / drug therapy-
dc.subject.MESHChemotherapy, Adjuvant-
dc.subject.MESHDisease-Free Survival-
dc.subject.MESHFemale-
dc.subject.MESHHumans-
dc.subject.MESHKi-67 Antigen-
dc.subject.MESHNeoplasm Recurrence, Local / drug therapy-
dc.subject.MESHReceptor, ErbB-2*-
dc.titleAdjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study-
dc.typeArticle-
dc.contributor.collegeCollege of Medicine (의과대학)-
dc.contributor.departmentDept. of Internal Medicine (내과학교실)-
dc.contributor.googleauthorN Harbeck-
dc.contributor.googleauthorP Rastogi-
dc.contributor.googleauthorM Martin-
dc.contributor.googleauthorS M Tolaney-
dc.contributor.googleauthorZ M Shao-
dc.contributor.googleauthorP A Fasching-
dc.contributor.googleauthorC S Huang-
dc.contributor.googleauthorG G Jaliffe-
dc.contributor.googleauthorA Tryakin-
dc.contributor.googleauthorM P Goetz-
dc.contributor.googleauthorH S Rugo-
dc.contributor.googleauthorE Senkus-
dc.contributor.googleauthorL Testa-
dc.contributor.googleauthorM Andersson-
dc.contributor.googleauthorK Tamura-
dc.contributor.googleauthorL Del Mastro-
dc.contributor.googleauthorG G Steger-
dc.contributor.googleauthorH Kreipe-
dc.contributor.googleauthorR Hegg-
dc.contributor.googleauthorJ Sohn-
dc.contributor.googleauthorV Guarneri-
dc.contributor.googleauthorJ Cortés-
dc.contributor.googleauthorE Hamilton-
dc.contributor.googleauthorV André-
dc.contributor.googleauthorR Wei-
dc.contributor.googleauthorS Barriga-
dc.contributor.googleauthorS Sherwood-
dc.contributor.googleauthorT Forrester-
dc.contributor.googleauthorM Munoz-
dc.contributor.googleauthorA Shahir-
dc.contributor.googleauthorB San Antonio-
dc.contributor.googleauthorS C Nabinger-
dc.contributor.googleauthorM Toi-
dc.contributor.googleauthorS R D Johnston-
dc.contributor.googleauthorJ O'Shaughnessy-
dc.identifier.doi10.1016/j.annonc.2021.09.015-
dc.contributor.localIdA01995-
dc.contributor.localIdA01682-
dc.contributor.localIdA05854-
dc.relation.journalcodeJ00171-
dc.identifier.eissn1569-8041-
dc.identifier.pmid34656740-
dc.subject.keywordCDK4/6-
dc.subject.keywordKi-67-
dc.subject.keywordabemaciclib-
dc.subject.keywordadjuvant-
dc.subject.keywordearly breast cancer-
dc.contributor.alternativeNameSohn, Joo Hyuk-
dc.contributor.affiliatedAuthor손주혁-
dc.contributor.affiliatedAuthor박중현-
dc.contributor.affiliatedAuthor조한얼-
dc.citation.volume32-
dc.citation.number12-
dc.citation.startPage1571-
dc.citation.endPage1581-
dc.identifier.bibliographicCitationANNALS OF ONCOLOGY, Vol.32(12) : 1571-1581, 2021-12-
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
1. College of Medicine (의과대학) > Dept. of Rehabilitation Medicine (재활의학교실) > 1. Journal Papers

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