Adjuvant Abemaciclib Plus Endocrine Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, High-Risk Early Breast Cancer: Results From a Preplanned monarchE Overall Survival Interim Analysis, Including 5-Year Efficacy Outcomes

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dc.contributor.authorRastogi, P.
dc.contributor.authorO'shaughnessy, J.
dc.contributor.authorMartin, M.
dc.contributor.authorBoyle, F.
dc.contributor.authorCortes, J.
dc.contributor.authorRugo, H.S.
dc.contributor.authorGoetz M.P.
dc.date.accessioned2024-05-19T14:34:46Z
dc.date.available2024-05-19T14:34:46Z
dc.date.issued2024
dc.departmentİstinye Üniversitesien_US
dc.description.abstractClinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned co-primary or secondary analyses are not yet available. Clinical trial updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported.Two years of adjuvant abemaciclib combined with endocrine therapy (ET) resulted in a significant improvement in invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS) that persisted beyond the 2-year treatment period in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative, node-positive, high-risk early breast cancer (EBC). Here, we report 5-year efficacy results from a prespecified overall survival (OS) interim analysis. In the intent-to-treat population, with a median follow-up of 54 months, the benefit of abemaciclib was sustained with hazard ratios of 0.680 (95% CI, 0.599 to 0.772) for IDFS and 0.675 (95% CI, 0.588 to 0.774) for DRFS. This persistence of abemaciclib benefit translated to continuous separation of the curves with a deepening in 5-year absolute improvement in IDFS and DRFS rates of 7.6% and 6.7%, respectively, compared with rates of 6% and 5.3% at 4 years and 4.8% and 4.1% at 3 years. With fewer deaths in the abemaciclib plus ET arm compared with the ET-alone arm (208 v 234), statistical significance was not reached for OS. No new safety signals were observed. In conclusion, abemaciclib plus ET continued to reduce the risk of developing invasive and distant disease recurrence beyond the completion of treatment. The increasing absolute improvement at 5 years is consistent with a carryover effect and further supports the use of abemaciclib in patients with high-risk EBC. © 2024 American Society of Clinical Oncology.en_US
dc.description.sponsorshipEli Lilly and Companyen_US
dc.description.sponsorshipSupported by Eli Lilly and Company.en_US
dc.identifier.doi10.1200/JCO.23.01994
dc.identifier.endpage993en_US
dc.identifier.issn0732-183X
dc.identifier.issue9en_US
dc.identifier.pmid38194616en_US
dc.identifier.scopus2-s2.0-85186459594en_US
dc.identifier.scopusqualityN/Aen_US
dc.identifier.startpage987en_US
dc.identifier.urihttps://doi.org/10.1200/JCO.23.01994
dc.identifier.urihttps://hdl.handle.net/20.500.12713/4549
dc.identifier.volume42en_US
dc.indekslendigikaynakScopusen_US
dc.indekslendigikaynakPubMeden_US
dc.language.isoenen_US
dc.publisherLippincott Williams and Wilkinsen_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.snmz20240519_kaen_US
dc.subjectAbemacicliben_US
dc.subjectAromatase İnhibitoren_US
dc.subjectTamoxifenen_US
dc.subjectAbemacicliben_US
dc.subjectAminopyridine Derivativeen_US
dc.subjectAntineoplastic Agenten_US
dc.subjectBenzimidazole Derivativeen_US
dc.subjectEpidermal Growth Factor Receptor 2en_US
dc.subjectErbb2 Protein, Humanen_US
dc.subjectİmmunological Adjuvanten_US
dc.subjectAdjuvant Chemotherapyen_US
dc.subjectAdulten_US
dc.subjectAgeden_US
dc.subjectArticleen_US
dc.subjectCancer Hormone Therapyen_US
dc.subjectCohort Analysisen_US
dc.subjectComparative Studyen_US
dc.subjectControlled Studyen_US
dc.subjectDistant Recurrence Free Survivalen_US
dc.subjectDrug Efficacyen_US
dc.subjectDrug Withdrawalen_US
dc.subjectFemaleen_US
dc.subjectFollow Upen_US
dc.subjectGastrointestinal Diseaseen_US
dc.subjectHormone Receptor-Positive, Her2-Negative Breast Canceren_US
dc.subjectHumanen_US
dc.subjectİnfectionen_US
dc.subjectMajor Clinical Studyen_US
dc.subjectMaleen_US
dc.subjectMortality Rateen_US
dc.subjectOverall Survivalen_US
dc.subjectPhase 3 Clinical Trialen_US
dc.subjectTreatment Outcomeen_US
dc.subjectBreast Tumoren_US
dc.subjectTumor Recurrenceen_US
dc.subjectAdjuvants, Immunologicen_US
dc.subjectAminopyridinesen_US
dc.subjectAntineoplastic Combined Chemotherapy Protocolsen_US
dc.subjectBenzimidazolesen_US
dc.subjectBreast Neoplasmsen_US
dc.subjectFemaleen_US
dc.subjectHumansen_US
dc.subjectNeoplasm Recurrence, Localen_US
dc.subjectReceptor, Erbb-2en_US
dc.titleAdjuvant Abemaciclib Plus Endocrine Therapy for Hormone Receptor-Positive, Human Epidermal Growth Factor Receptor 2-Negative, High-Risk Early Breast Cancer: Results From a Preplanned monarchE Overall Survival Interim Analysis, Including 5-Year Efficacy Outcomesen_US
dc.typeArticleen_US

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