Cited 199 times in
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.author | 손주혁 | - |
dc.contributor.author | 박중현 | - |
dc.contributor.author | 조한얼 | - |
dc.date.accessioned | 2022-09-14T01:55:57Z | - |
dc.date.available | 2022-09-14T01:55:57Z | - |
dc.date.issued | 2021-12 | - |
dc.identifier.issn | 0923-7534 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/190674 | - |
dc.description.abstract | Background: 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.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Oxford University Press | - |
dc.relation.isPartOf | ANNALS OF ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Aminopyridines | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / therapeutic use | - |
dc.subject.MESH | Benzimidazoles | - |
dc.subject.MESH | Breast Neoplasms* / drug therapy | - |
dc.subject.MESH | Chemotherapy, Adjuvant | - |
dc.subject.MESH | Disease-Free Survival | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Ki-67 Antigen | - |
dc.subject.MESH | Neoplasm Recurrence, Local / drug therapy | - |
dc.subject.MESH | Receptor, ErbB-2* | - |
dc.title | Adjuvant abemaciclib combined with endocrine therapy for high-risk early breast cancer: updated efficacy and Ki-67 analysis from the monarchE study | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | N Harbeck | - |
dc.contributor.googleauthor | P Rastogi | - |
dc.contributor.googleauthor | M Martin | - |
dc.contributor.googleauthor | S M Tolaney | - |
dc.contributor.googleauthor | Z M Shao | - |
dc.contributor.googleauthor | P A Fasching | - |
dc.contributor.googleauthor | C S Huang | - |
dc.contributor.googleauthor | G G Jaliffe | - |
dc.contributor.googleauthor | A Tryakin | - |
dc.contributor.googleauthor | M P Goetz | - |
dc.contributor.googleauthor | H S Rugo | - |
dc.contributor.googleauthor | E Senkus | - |
dc.contributor.googleauthor | L Testa | - |
dc.contributor.googleauthor | M Andersson | - |
dc.contributor.googleauthor | K Tamura | - |
dc.contributor.googleauthor | L Del Mastro | - |
dc.contributor.googleauthor | G G Steger | - |
dc.contributor.googleauthor | H Kreipe | - |
dc.contributor.googleauthor | R Hegg | - |
dc.contributor.googleauthor | J Sohn | - |
dc.contributor.googleauthor | V Guarneri | - |
dc.contributor.googleauthor | J Cortés | - |
dc.contributor.googleauthor | E Hamilton | - |
dc.contributor.googleauthor | V André | - |
dc.contributor.googleauthor | R Wei | - |
dc.contributor.googleauthor | S Barriga | - |
dc.contributor.googleauthor | S Sherwood | - |
dc.contributor.googleauthor | T Forrester | - |
dc.contributor.googleauthor | M Munoz | - |
dc.contributor.googleauthor | A Shahir | - |
dc.contributor.googleauthor | B San Antonio | - |
dc.contributor.googleauthor | S C Nabinger | - |
dc.contributor.googleauthor | M Toi | - |
dc.contributor.googleauthor | S R D Johnston | - |
dc.contributor.googleauthor | J O'Shaughnessy | - |
dc.identifier.doi | 10.1016/j.annonc.2021.09.015 | - |
dc.contributor.localId | A01995 | - |
dc.contributor.localId | A01682 | - |
dc.contributor.localId | A05854 | - |
dc.relation.journalcode | J00171 | - |
dc.identifier.eissn | 1569-8041 | - |
dc.identifier.pmid | 34656740 | - |
dc.subject.keyword | CDK4/6 | - |
dc.subject.keyword | Ki-67 | - |
dc.subject.keyword | abemaciclib | - |
dc.subject.keyword | adjuvant | - |
dc.subject.keyword | early breast cancer | - |
dc.contributor.alternativeName | Sohn, Joo Hyuk | - |
dc.contributor.affiliatedAuthor | 손주혁 | - |
dc.contributor.affiliatedAuthor | 박중현 | - |
dc.contributor.affiliatedAuthor | 조한얼 | - |
dc.citation.volume | 32 | - |
dc.citation.number | 12 | - |
dc.citation.startPage | 1571 | - |
dc.citation.endPage | 1581 | - |
dc.identifier.bibliographicCitation | ANNALS OF ONCOLOGY, Vol.32(12) : 1571-1581, 2021-12 | - |
Items in DSpace are protected by copyright, with all rights reserved, unless otherwise indicated.