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Abemaciclib in combination with endocrine therapy for East Asian patients with HR+, HER2- advanced breast cancer: MONARCH 2 & 3 trials

Authors
 Masakazu Toi  ;  Kenichi Inoue  ;  Norikazu Masuda  ;  Hiroji Iwata  ;  Joohyuk Sohn  ;  In Hae Park  ;  Seock-Ah Im  ;  Shin-Cheh Chen  ;  Sotaro Enatsu  ;  P Kellie Turner  ;  Valérie A M André  ;  Molly C Hardebeck  ;  Sachi Sakaguchi  ;  Matthew P Goetz  ;  George W Sledge Jr 
Citation
 CANCER SCIENCE, Vol.112(6) : 2381-2392, 2021-06 
Journal Title
CANCER SCIENCE
ISSN
 1347-9032 
Issue Date
2021-06
MeSH
Aminopyridines / administration & dosage* ; Aminopyridines / adverse effects ; Aminopyridines / pharmacokinetics ; Anastrozole / administration & dosage ; Anastrozole / adverse effects ; Anastrozole / pharmacokinetics ; Aromatase Inhibitors / administration & dosage* ; Aromatase Inhibitors / adverse effects ; Aromatase Inhibitors / pharmacokinetics ; Benzimidazoles / administration & dosage* ; Benzimidazoles / adverse effects ; Benzimidazoles / pharmacokinetics ; Breast Neoplasms / blood ; Breast Neoplasms / drug therapy* ; Breast Neoplasms / genetics ; Diarrhea / chemically induced ; Diarrhea / epidemiology ; Double-Blind Method ; Drug Therapy, Combination ; Female ; Fulvestrant / administration & dosage* ; Fulvestrant / adverse effects ; Fulvestrant / pharmacokinetics ; Humans ; Letrozole / administration & dosage ; Letrozole / adverse effects ; Letrozole / pharmacokinetics ; Neutropenia / chemically induced ; Neutropenia / epidemiology ; Receptor, ErbB-2 / genetics ; Treatment Outcome
Keywords
East Asia ; abemaciclib ; breast cancer ; cyclin-dependent kinase inhibitor ; metastatic
Abstract
This post hoc analysis of MONARCH 2 and MONARCH 3 assesses the efficacy, safety, and pharmacokinetics (PK) of abemaciclib in combination with endocrine therapy (ET) in East Asian patients with hormone receptor positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) advanced breast cancer. MONARCH 2 and MONARCH 3 are global, randomized, double-blind, phase 3 studies of abemaciclib/placebo + fulvestrant and abemaciclib/placebo + nonsteroidal aromatase inhibitor (NSAI, anastrozole or letrozole), respectively. The East Asian population comprised 212 (31.7%) of the 669 intent-to-treat (ITT) population in the MONARCH 2 trial and 144 (29.2%) of the 493 ITT patients in the MONARCH 3 trial. In the East Asian population, median progression-free survival (PFS) was significantly prolonged in the abemaciclib arm compared with placebo in both MONARCH 2 (hazard ratio [HR], 0.520; 95% confidence interval [CI], 0.362 to 0.747; P < .001; median: 21.2 vs 11.6 months) and MONARCH 3 (HR, 0.326; 95% CI, 0.200 to 0.531, P < .001; median: not reached vs 12.82 months). Diarrhea (MONARCH 2: 90%; MONARCH 3: 88%) and neutropenia (MONARCH 2: 68%; MONARCH 3: 58%) were the most frequent adverse events observed in the East Asian populations. Abemaciclib exposures and PK were similar in East Asians and the non-East Asian populations of both trials. Abemaciclib in combination with ET in the East Asian populations of MONARCH 2 and MONARCH 3 provided consistent results with the ITT populations, demonstrating improvements in efficacy with generally tolerable safety profiles for patients with HR+, HER2- advanced breast cancer.
Full Text
https://onlinelibrary.wiley.com/doi/10.1111/cas.14877
DOI
10.1111/cas.14877
Appears in Collections:
1. College of Medicine (의과대학) > Dept. of Internal Medicine (내과학교실) > 1. Journal Papers
Yonsei Authors
Sohn, Joo Hyuk(손주혁) ORCID logo https://orcid.org/0000-0002-2303-2764
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/190887
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