Impact of dose reductions on adjuvant abemaciclib efficacy for patients with high-risk early breast cancer: analyses from the monarchE study

dc.authoridMARTIN, MIGUEL/0000-0001-9237-3231
dc.authoridGoetz, Matthew/0000-0002-4383-270X
dc.authoridHarbeck, Nadia/0000-0002-9744-7372
dc.contributor.authorGoetz, Matthew P.
dc.contributor.authorCicin, Irfan
dc.contributor.authorTesta, Laura
dc.contributor.authorTolaney, Sara M.
dc.contributor.authorHuober, Jens
dc.contributor.authorGuarneri, Valentina
dc.contributor.authorJohnston, Stephen R. D.
dc.date.accessioned2024-05-19T14:50:35Z
dc.date.available2024-05-19T14:50:35Z
dc.date.issued2024
dc.departmentİstinye Üniversitesien_US
dc.description.abstractIn monarchE, adjuvant abemaciclib significantly improved invasive disease-free survival (IDFS) and distant relapse-free survival (DRFS), with sustained benefit beyond the 2-year treatment period. Abemaciclib dose reductions were allowed to proactively manage adverse events. Exploratory analyses to investigate the impact of dose reductions on efficacy were conducted. Across the three patient subgroups as defined by relative dose intensity (<= 66%, 66-93%, >= 93%), the estimated 4-year IDFS rates were generally consistent (87.1%, 86.4%, and 83.7%, respectively). In the time-dependent Cox proportional hazard model, the effect of abemaciclib was consistent at the full dose compared to being reduced to a lower dose (IDFS hazard ratio: 0.905; 95% confidence interval: 0.727, 1.125; DRFS hazard ratio: 0.942; 95% confidence interval: 0.742, 1.195). These analyses showed that the efficacy of adjuvant abemaciclib was not compromised by protocol mandated dose reductions for patients with node positive, hormone receptor positive, human epidermal growth factor 2-negative, high-risk early breast cancer.en_US
dc.description.sponsorshipEli Lilly and companyen_US
dc.description.sponsorshipThis work was supported by Eli Lilly and Company. Eli Lilly had a role in the design of the study and collection, analysis, and interpretation of data and in writing. We thank the 5637 patients and their families/caregivers from 603 sites in 38 countries for participating in this trial. We would like to generously thank the investigators and their support staff who participated in this work. We are also very grateful for the time and efforts of the monarchE Executive and Global Steering Committees. Dr. Goetz is the Erivan K. Haub Family Professor of Cancer Research Honoring Richard F. Emslander, M.D. Writing and editorial support were provided by Preethi Govindarajan and Adrienne Schreiber of Syneos health.en_US
dc.identifier.doi10.1038/s41523-024-00639-1
dc.identifier.issn2374-4677
dc.identifier.issue1en_US
dc.identifier.pmid38671001en_US
dc.identifier.scopus2-s2.0-85191694373en_US
dc.identifier.scopusqualityQ1en_US
dc.identifier.urihttps://doi.org10.1038/s41523-024-00639-1
dc.identifier.urihttps://hdl.handle.net/20.500.12713/5753
dc.identifier.volume10en_US
dc.identifier.wosWOS:001209717800001en_US
dc.identifier.wosqualityN/Aen_US
dc.indekslendigikaynakWeb of Scienceen_US
dc.indekslendigikaynakScopusen_US
dc.language.isoenen_US
dc.publisherNature Portfolioen_US
dc.relation.ispartofNpj Breast Canceren_US
dc.relation.publicationcategoryMakale - Uluslararası Hakemli Dergi - Kurum Öğretim Elemanıen_US
dc.rightsinfo:eu-repo/semantics/openAccessen_US
dc.snmz20240519_kaen_US
dc.subjectEndocrine Therapyen_US
dc.subjectPostmenopausal Womenen_US
dc.titleImpact of dose reductions on adjuvant abemaciclib efficacy for patients with high-risk early breast cancer: analyses from the monarchE studyen_US
dc.typeArticleen_US

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