Abemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE)

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dc.authoridMAZILU, LAURA/0000-0001-6195-4500
dc.authoridMartin, Miguel/0000-0001-9237-3231
dc.authoridColomer, Ramon/0000-0002-6393-3444
dc.authoridHarbeck, Nadia/0000-0002-9744-7372
dc.authoridWardley, Andrew/0000-0002-9639-0888
dc.authoridHegg, Roberto/0000-0002-6453-8155
dc.authoridSohn, Joohyuk/0000-0002-2303-2764
dc.authorwosidwei, wei/IQW-1347-2023
dc.authorwosidZhang, Qing/HTT-5047-2023
dc.authorwosidMAZILU, LAURA/S-5111-2018
dc.authorwosidMartin, Miguel/AAJ-9242-2020
dc.authorwosidColomer, Ramon/C-5142-2008
dc.authorwosidZhang, Qing/IZQ-5273-2023
dc.authorwosidwei, wei/HHR-8613-2022
dc.contributor.authorJohnston, Stephen R. D.
dc.contributor.authorHarbeck, Nadia
dc.contributor.authorHegg, Roberto
dc.contributor.authorToi, Masakazu
dc.contributor.authorMartin, Miguel
dc.contributor.authorShao, Zhi Min
dc.contributor.authorZhang, Qing Yuan
dc.date.accessioned2024-06-12T11:17:29Z
dc.date.available2024-06-12T11:17:29Z
dc.date.issued2020
dc.departmentTrakya Üniversitesien_US
dc.description.abstractPURPOSEMany patients with HR+, HER2- early breast cancer (EBC) will not experience recurrence or have distant recurrence with currently available standard therapies. However, up to 30% of patients with high-risk clinical and/or pathologic features may experience distant recurrence, many in the first few years. Superior treatment options are needed to prevent early recurrence and development of metastases for this group of patients. Abemaciclib is an oral, continuously dosed, CDK4/6 inhibitor approved for HR+, HER2- advanced breast cancer (ABC). Efficacy and safety of abemaciclib in ABC supported evaluation in the adjuvant setting.METHODSThis open-label, phase III study included patients with HR+, HER2-, high-risk EBC, who had surgery and, as indicated, radiotherapy and/or adjuvant/neoadjuvant chemotherapy. Patients with four or more positive nodes, or one to threenodes and either tumor size >= 5 cm, histologic grade 3, or central Ki-67 >= 20%, were eligible and randomly assigned (1:1) to standard-of-care adjuvant endocrine therapy (ET) with or without abemaciclib (150 mg twice daily for 2 years). The primary end point was invasive disease-free survival (IDFS), and secondary end points included distant relapse-free survival, overall survival, and safety.RESULTSAt a preplanned efficacy interim analysis, among 5,637randomly assigned patients, 323 IDFS events were observed in the intent-to-treat population. Abemaciclib plus ET demonstrated superior IDFS versus ET alone (P = .01; hazard ratio, 0.75; 95% CI, 0.60 to 0.93), with 2-year IDFS rates of 92.2% versus 88.7%, respectively. Safety data were consistent with the known safety profile of abemaciclib.CONCLUSIONAbemaciclib when combined with ET is the first CDK4/6 inhibitor to demonstrate a significant improvement in IDFS in patients with HR+, HER2- node-positive EBC at high risk of early recurrence.en_US
dc.description.sponsorshipEli Lilly and Company; National Institute for Health Research; Institute of Cancer Research Biomedical Research Centeren_US
dc.description.sponsorshipFunded and sponsored by Eli Lilly and Company. Additional support provided by National Institute for Health Research funding to the Royal Marsden and Institute of Cancer Research Biomedical Research Center.en_US
dc.identifier.doi10.1200/JCO.20.02514
dc.identifier.issn0732-183X
dc.identifier.issn1527-7755
dc.identifier.issue34en_US
dc.identifier.pmid32954927en_US
dc.identifier.scopus2-s2.0-85095442532en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.urihttps://doi.org/10.1200/JCO.20.02514
dc.identifier.urihttps://hdl.handle.net/20.500.14551/24722
dc.identifier.volume38en_US
dc.identifier.wosWOS:000597880600004en_US
dc.identifier.wosqualityQ1en_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherAmer Soc Clinical Oncologyen_US
dc.relation.ispartofJournal Of Clinical Oncologyen_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.subject21-Gene Recurrence Scoreen_US
dc.subjectTamoxifenen_US
dc.titleAbemaciclib Combined With Endocrine Therapy for the Adjuvant Treatment of HR+, HER2-, Node-Positive, High-Risk, Early Breast Cancer (monarchE)en_US
dc.typeArticleen_US

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