Cited 12 times in
Abemaciclib in combination with endocrine therapy for East Asian patients with HR+, HER2- advanced breast cancer: MONARCH 2 & 3 trials
DC Field | Value | Language |
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dc.contributor.author | 손주혁 | - |
dc.date.accessioned | 2022-11-24T00:40:37Z | - |
dc.date.available | 2022-11-24T00:40:37Z | - |
dc.date.issued | 2021-06 | - |
dc.identifier.issn | 1347-9032 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/190887 | - |
dc.description.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. | - |
dc.description.statementOfResponsibility | open | - |
dc.language | English | - |
dc.publisher | Wiley Publishing on behalf of the Japanese Cancer Association | - |
dc.relation.isPartOf | CANCER SCIENCE | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Aminopyridines / administration & dosage* | - |
dc.subject.MESH | Aminopyridines / adverse effects | - |
dc.subject.MESH | Aminopyridines / pharmacokinetics | - |
dc.subject.MESH | Anastrozole / administration & dosage | - |
dc.subject.MESH | Anastrozole / adverse effects | - |
dc.subject.MESH | Anastrozole / pharmacokinetics | - |
dc.subject.MESH | Aromatase Inhibitors / administration & dosage* | - |
dc.subject.MESH | Aromatase Inhibitors / adverse effects | - |
dc.subject.MESH | Aromatase Inhibitors / pharmacokinetics | - |
dc.subject.MESH | Benzimidazoles / administration & dosage* | - |
dc.subject.MESH | Benzimidazoles / adverse effects | - |
dc.subject.MESH | Benzimidazoles / pharmacokinetics | - |
dc.subject.MESH | Breast Neoplasms / blood | - |
dc.subject.MESH | Breast Neoplasms / drug therapy* | - |
dc.subject.MESH | Breast Neoplasms / genetics | - |
dc.subject.MESH | Diarrhea / chemically induced | - |
dc.subject.MESH | Diarrhea / epidemiology | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Drug Therapy, Combination | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Fulvestrant / administration & dosage* | - |
dc.subject.MESH | Fulvestrant / adverse effects | - |
dc.subject.MESH | Fulvestrant / pharmacokinetics | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Letrozole / administration & dosage | - |
dc.subject.MESH | Letrozole / adverse effects | - |
dc.subject.MESH | Letrozole / pharmacokinetics | - |
dc.subject.MESH | Neutropenia / chemically induced | - |
dc.subject.MESH | Neutropenia / epidemiology | - |
dc.subject.MESH | Receptor, ErbB-2 / genetics | - |
dc.subject.MESH | Treatment Outcome | - |
dc.title | Abemaciclib in combination with endocrine therapy for East Asian patients with HR+, HER2- advanced breast cancer: MONARCH 2 & 3 trials | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Masakazu Toi | - |
dc.contributor.googleauthor | Kenichi Inoue | - |
dc.contributor.googleauthor | Norikazu Masuda | - |
dc.contributor.googleauthor | Hiroji Iwata | - |
dc.contributor.googleauthor | Joohyuk Sohn | - |
dc.contributor.googleauthor | In Hae Park | - |
dc.contributor.googleauthor | Seock-Ah Im | - |
dc.contributor.googleauthor | Shin-Cheh Chen | - |
dc.contributor.googleauthor | Sotaro Enatsu | - |
dc.contributor.googleauthor | P Kellie Turner | - |
dc.contributor.googleauthor | Valérie A M André | - |
dc.contributor.googleauthor | Molly C Hardebeck | - |
dc.contributor.googleauthor | Sachi Sakaguchi | - |
dc.contributor.googleauthor | Matthew P Goetz | - |
dc.contributor.googleauthor | George W Sledge Jr | - |
dc.identifier.doi | 10.1111/cas.14877 | - |
dc.contributor.localId | A01995 | - |
dc.relation.journalcode | J00454 | - |
dc.identifier.eissn | 1349-7006 | - |
dc.identifier.pmid | 33686753 | - |
dc.identifier.url | https://onlinelibrary.wiley.com/doi/10.1111/cas.14877 | - |
dc.subject.keyword | East Asia | - |
dc.subject.keyword | abemaciclib | - |
dc.subject.keyword | breast cancer | - |
dc.subject.keyword | cyclin-dependent kinase inhibitor | - |
dc.subject.keyword | metastatic | - |
dc.contributor.alternativeName | Sohn, Joo Hyuk | - |
dc.contributor.affiliatedAuthor | 손주혁 | - |
dc.citation.volume | 112 | - |
dc.citation.number | 6 | - |
dc.citation.startPage | 2381 | - |
dc.citation.endPage | 2392 | - |
dc.identifier.bibliographicCitation | CANCER SCIENCE, Vol.112(6) : 2381-2392, 2021-06 | - |
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