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MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer
DC Field | Value | Language |
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dc.contributor.author | 손주혁 | - |
dc.date.accessioned | 2023-08-09T02:41:24Z | - |
dc.date.available | 2023-08-09T02:41:24Z | - |
dc.date.issued | 2017-11 | - |
dc.identifier.issn | 0732-183X | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/195752 | - |
dc.description.abstract | Purpose Abemaciclib, a cyclin-dependent kinase 4 and 6 inhibitor, demonstrated efficacy as monotherapy and in combination with fulvestrant in women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer previously treated with endocrine therapy. Methods MONARCH 3 is a double-blind, randomized phase III study of abemaciclib or placebo plus a nonsteroidal aromatase inhibitor in 493 postmenopausal women with HR-positive, HER2-negative advanced breast cancer who had no prior systemic therapy in the advanced setting. Patients received abemaciclib or placebo (150 mg twice daily continuous schedule) plus either 1 mg anastrozole or 2.5 mg letrozole, daily. The primary objective was investigator-assessed progression-free survival. Secondary objectives included response evaluation and safety. A planned interim analysis occurred after 189 events. Results Median progression-free survival was significantly prolonged in the abemaciclib arm (hazard ratio, 0.54; 95% CI, 0.41 to 0.72; P = .000021; median: not reached in the abemaciclib arm, 14.7 months in the placebo arm). In patients with measurable disease, the objective response rate was 59% in the abemaciclib arm and 44% in the placebo arm ( P = .004). In the abemaciclib arm, diarrhea was the most frequent adverse effect (81.3%) but was mainly grade 1 (44.6%). Comparing abemaciclib and placebo, the most frequent grade 3 or 4 adverse events were neutropenia (21.1% v 1.2%), diarrhea (9.5% v 1.2%), and leukopenia (7.6% v 0.6%). Conclusion Abemaciclib plus a nonsteroidal aromatase inhibitor was effective as initial therapy, significantly improving progression-free survival and objective response rate and demonstrating a tolerable safety profile in women with HR-positive, HER2-negative advanced breast cancer. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | American Society of Clinical Oncology | - |
dc.relation.isPartOf | JOURNAL OF CLINICAL ONCOLOGY | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Adult | - |
dc.subject.MESH | Aged | - |
dc.subject.MESH | Aged, 80 and over | - |
dc.subject.MESH | Aminopyridines / administration & dosage* | - |
dc.subject.MESH | Anastrozole | - |
dc.subject.MESH | Antineoplastic Combined Chemotherapy Protocols / therapeutic use* | - |
dc.subject.MESH | Aromatase Inhibitors / administration & dosage* | - |
dc.subject.MESH | Benzimidazoles / administration & dosage* | - |
dc.subject.MESH | Biomarkers, Tumor | - |
dc.subject.MESH | Breast Neoplasms / drug therapy* | - |
dc.subject.MESH | Double-Blind Method | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Letrozole | - |
dc.subject.MESH | Middle Aged | - |
dc.subject.MESH | Nitriles / administration & dosage* | - |
dc.subject.MESH | Postmenopause | - |
dc.subject.MESH | Receptor, ErbB-2 | - |
dc.subject.MESH | Survival Rate | - |
dc.subject.MESH | Treatment Outcome | - |
dc.subject.MESH | Triazoles / administration & dosage* | - |
dc.title | MONARCH 3: Abemaciclib As Initial Therapy for Advanced Breast Cancer | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Matthew P Goetz | - |
dc.contributor.googleauthor | Masakazu Toi | - |
dc.contributor.googleauthor | Mario Campone | - |
dc.contributor.googleauthor | Joohyuk Sohn | - |
dc.contributor.googleauthor | Shani Paluch-Shimon | - |
dc.contributor.googleauthor | Jens Huober | - |
dc.contributor.googleauthor | In Hae Park | - |
dc.contributor.googleauthor | Olivier Trédan | - |
dc.contributor.googleauthor | Shin-Cheh Chen | - |
dc.contributor.googleauthor | Luis Manso | - |
dc.contributor.googleauthor | Orit C Freedman | - |
dc.contributor.googleauthor | Georgina Garnica Jaliffe | - |
dc.contributor.googleauthor | Tammy Forrester | - |
dc.contributor.googleauthor | Martin Frenzel | - |
dc.contributor.googleauthor | Susana Barriga | - |
dc.contributor.googleauthor | Ian C Smith | - |
dc.contributor.googleauthor | Nawel Bourayou | - |
dc.contributor.googleauthor | Angelo Di Leo | - |
dc.identifier.doi | 10.1200/JCO.2017.75.6155 | - |
dc.contributor.localId | A01995 | - |
dc.contributor.localId | A00654 | - |
dc.relation.journalcode | J01331 | - |
dc.identifier.eissn | 1527-7755 | - |
dc.identifier.pmid | 28968163 | - |
dc.identifier.url | https://ascopubs.org/doi/10.1200/JCO.2017.75.6155 | - |
dc.contributor.alternativeName | Sohn, Joo Hyuk | - |
dc.contributor.affiliatedAuthor | 손주혁 | - |
dc.citation.volume | 35 | - |
dc.citation.number | 32 | - |
dc.citation.startPage | 3638 | - |
dc.citation.endPage | 3646 | - |
dc.identifier.bibliographicCitation | JOURNAL OF CLINICAL ONCOLOGY, Vol.35(32) : 3638-3646, 2017-11 | - |
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