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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

 N Harbeck  ;  P Rastogi  ;  M Martin  ;  S M Tolaney  ;  Z M Shao  ;  P A Fasching  ;  C S Huang  ;  G G Jaliffe  ;  A Tryakin  ;  M P Goetz  ;  H S Rugo  ;  E Senkus  ;  L Testa  ;  M Andersson  ;  K Tamura  ;  L Del Mastro  ;  G G Steger  ;  H Kreipe  ;  R Hegg  ;  J Sohn  ;  V Guarneri  ;  J Cortés  ;  E Hamilton  ;  V André  ;  R Wei  ;  S Barriga  ;  S Sherwood  ;  T Forrester  ;  M Munoz  ;  A Shahir  ;  B San Antonio  ;  S C Nabinger  ;  M Toi  ;  S R D Johnston  ;  J O'Shaughnessy 
 ANNALS OF ONCOLOGY, Vol.32(12) : 1571-1581, 2021-12 
Journal Title
Issue Date
Aminopyridines ; Antineoplastic Combined Chemotherapy Protocols / therapeutic use ; Benzimidazoles ; Breast Neoplasms* / drug therapy ; Chemotherapy, Adjuvant ; Disease-Free Survival ; Female ; Humans ; Ki-67 Antigen ; Neoplasm Recurrence, Local / drug therapy ; Receptor, ErbB-2*
CDK4/6 ; Ki-67 ; abemaciclib ; adjuvant ; early breast cancer
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.
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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
Yonsei Authors
Park, Jung Hyun(박중현) ORCID logo https://orcid.org/0000-0003-3262-7476
Sohn, Joo Hyuk(손주혁) ORCID logo https://orcid.org/0000-0002-2303-2764
Cho, Han Eol(조한얼) ORCID logo https://orcid.org/0000-0001-5625-3013
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