Mostrar el registro sencillo del ítem

Artículo

dc.creatorNeven, P.es
dc.creatorFasching, P. A.es
dc.creatorChia, S.es
dc.creatorJerusalem, G.es
dc.creatorDe Laurentiis, M.es
dc.creatorIm, S. A.es
dc.creatorCruz Merino, Luis de laes
dc.creatorSlamon, D. J.es
dc.date.accessioned2024-03-04T14:41:08Z
dc.date.available2024-03-04T14:41:08Z
dc.date.issued2023
dc.identifier.citationNeven, P., Fasching, P.A., Chia, S., Jerusalem, G., De Laurentiis, M., Im, S.A.,...,Slamon, D.J. (2023). Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving frst-line ribociclib plus fulvestrant. Breast Cancer Research, 25 (1), 103. https://doi.org/10.1186/s13058-023-01701-9.
dc.identifier.issn1465-5411es
dc.identifier.issn1465-542Xes
dc.identifier.urihttps://hdl.handle.net/11441/155798
dc.description.abstractBackground The phase III MONALEESA-3 trial included frst- (1L) and second-line (2L) patients and demonstrated a signifcant overall survival (OS) beneft for ribociclib+fulvestrant in patients with hormone receptor–positive, human epidermal growth factor receptor 2–negative (HR+/HER2−) advanced breast cancer (ABC) in the fnal protocol-specifed and exploratory (longer follow-up) OS analyses. At the time of these analyses, the full OS beneft of 1L ribociclib was not completely characterized because the median OS (mOS) was not reached. As CDK4/6 inhibi‑ tor (CDK4/6i)+endocrine therapy (ET) is now a preferred option for 1L HR+/HER2− ABC, we report an exploratory analysis (median follow-up, 70.8 months; 14.5 months longer than the prior analysis) to fully elucidate the OS beneft in the MONALEESA-3 1L population. Methods Postmenopausal patients with HR+/HER2− ABC were randomized 2:1 to 1L/2L fulvestrant+riboci‑ clib or placebo. OS in 1L patients (de novo disease or relapse>12 months from completion of [neo]adjuvant ET) was assessed by Cox proportional hazards model and Kaplan–Meier methods. Progression-free survival 2 (PFS2) and chemotherapy-free survival (CFS) were analyzed. MONALEESA-3 is registered with ClinicalTrials.gov (NCT02422615). Results At data cutof (January 12, 2022; median follow-up time, 70.8 months), mOS was 67.6 versus 51.8 months with 1L ribociclib versus placebo (hazard ratio (HR) 0.67; 95% CI 0.50–0.90); 16.5% and 8.6% of ribociclib and placebo patients, respectively, were still receiving treatment. PFS2 (HR 0.64) and CFS (HR 0.62) favored ribociclib versus pla‑ cebo. Among those who discontinued treatment, 16.7% and 35.0% on ribociclib or placebo, respectively, received a subsequent CDK4/6i. No new safety signals were observed. This analysis of MONALEESA-3 reports the longest mOS thus far (67.6 months) for 1L patients in a phase III ABC trial. These results in a 1L population show that the OS beneft of ribociclib was maintained through extended follow-up, further supporting its use in HR+/HER2− ABC.es
dc.formatapplication/pdfes
dc.format.extent10 p.es
dc.language.isoenges
dc.publisherBiomed Central LTDes
dc.relation.ispartofBreast Cancer Research, 25 (1), 103.
dc.rightsAtribución 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/*
dc.subjectRibociclibes
dc.subjectCDK4/6 inhibitores
dc.subjectAdvanced breast canceres
dc.subjectOverall survivales
dc.subjectFirst linees
dc.titleUpdated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving frst-line ribociclib plus fulvestrantes
dc.typeinfo:eu-repo/semantics/articlees
dc.type.versioninfo:eu-repo/semantics/publishedVersiones
dc.rights.accessRightsinfo:eu-repo/semantics/openAccesses
dc.contributor.affiliationUniversidad de Sevilla. Departamento de Medicinaes
dc.relation.publisherversionhttps://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-023-01701-9es
dc.identifier.doi10.1186/s13058-023-01701-9es
dc.contributor.groupUniversidad de Sevilla. CTS151: Bioquímica médica.es
dc.journaltitleBreast Cancer Researches
dc.publication.volumen25es
dc.publication.issue1es
dc.publication.initialPage103es

FicherosTamañoFormatoVerDescripción
Updated overall survival.pdf1.878MbIcon   [PDF] Ver/Abrir  

Este registro aparece en las siguientes colecciones

Mostrar el registro sencillo del ítem

Atribución 4.0 Internacional
Excepto si se señala otra cosa, la licencia del ítem se describe como: Atribución 4.0 Internacional