dc.creator | Neven, P. | es |
dc.creator | Fasching, P. A. | es |
dc.creator | Chia, S. | es |
dc.creator | Jerusalem, G. | es |
dc.creator | De Laurentiis, M. | es |
dc.creator | Im, S. A. | es |
dc.creator | Cruz Merino, Luis de la | es |
dc.creator | Slamon, D. J. | es |
dc.date.accessioned | 2024-03-04T14:41:08Z | |
dc.date.available | 2024-03-04T14:41:08Z | |
dc.date.issued | 2023 | |
dc.identifier.citation | Neven, 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.issn | 1465-5411 | es |
dc.identifier.issn | 1465-542X | es |
dc.identifier.uri | https://hdl.handle.net/11441/155798 | |
dc.description.abstract | Background 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.format | application/pdf | es |
dc.format.extent | 10 p. | es |
dc.language.iso | eng | es |
dc.publisher | Biomed Central LTD | es |
dc.relation.ispartof | Breast Cancer Research, 25 (1), 103. | |
dc.rights | Atribución 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | * |
dc.subject | Ribociclib | es |
dc.subject | CDK4/6 inhibitor | es |
dc.subject | Advanced breast cancer | es |
dc.subject | Overall survival | es |
dc.subject | First line | es |
dc.title | Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving frst-line ribociclib plus fulvestrant | es |
dc.type | info:eu-repo/semantics/article | es |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.relation.publisherversion | https://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-023-01701-9 | es |
dc.identifier.doi | 10.1186/s13058-023-01701-9 | es |
dc.contributor.group | Universidad de Sevilla. CTS151: Bioquímica médica. | es |
dc.journaltitle | Breast Cancer Research | es |
dc.publication.volumen | 25 | es |
dc.publication.issue | 1 | es |
dc.publication.initialPage | 103 | es |