Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving frst-line ribociclib plus fulvestrant

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...

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Autores: Neven, P., Fasching, P. A., Chia, S., Jerusalem, G., De Laurentiis, M., Im, S. A., Cruz Merino, Luis de la, Slamon, D. J.
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Institución:Universidad de Sevilla (US)
Repositorio:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:idus.us.es:11441/155798
Acceso en línea:https://hdl.handle.net/11441/155798
https://doi.org/10.1186/s13058-023-01701-9
Access Level:acceso abierto
Palabra clave:Ribociclib
CDK4/6 inhibitor
Advanced breast cancer
Overall survival
First line
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spelling Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving frst-line ribociclib plus fulvestrantNeven, P.Fasching, P. A.Chia, S.Jerusalem, G.De Laurentiis, M.Im, S. A.Cruz Merino, Luis de laSlamon, D. J.RibociclibCDK4/6 inhibitorAdvanced breast cancerOverall survivalFirst lineBackground 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.Biomed Central LTDMedicinaCTS151: Bioquímica médica2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/155798https://doi.org/10.1186/s13058-023-01701-9reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)InglésBreast Cancer Research, 25 (1), 103.https://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-023-01701-9info:eu-repo/semantics/openAccessoai:idus.us.es:11441/1557982026-06-17T12:51:07Z
dc.title.none.fl_str_mv Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving frst-line ribociclib plus fulvestrant
title Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving frst-line ribociclib plus fulvestrant
spellingShingle Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving frst-line ribociclib plus fulvestrant
Neven, P.
Ribociclib
CDK4/6 inhibitor
Advanced breast cancer
Overall survival
First line
title_short Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving frst-line ribociclib plus fulvestrant
title_full Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving frst-line ribociclib plus fulvestrant
title_fullStr Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving frst-line ribociclib plus fulvestrant
title_full_unstemmed Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving frst-line ribociclib plus fulvestrant
title_sort Updated overall survival from the MONALEESA-3 trial in postmenopausal women with HR+/HER2− advanced breast cancer receiving frst-line ribociclib plus fulvestrant
dc.creator.none.fl_str_mv Neven, P.
Fasching, P. A.
Chia, S.
Jerusalem, G.
De Laurentiis, M.
Im, S. A.
Cruz Merino, Luis de la
Slamon, D. J.
author Neven, P.
author_facet Neven, P.
Fasching, P. A.
Chia, S.
Jerusalem, G.
De Laurentiis, M.
Im, S. A.
Cruz Merino, Luis de la
Slamon, D. J.
author_role author
author2 Fasching, P. A.
Chia, S.
Jerusalem, G.
De Laurentiis, M.
Im, S. A.
Cruz Merino, Luis de la
Slamon, D. J.
author2_role author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv Medicina
CTS151: Bioquímica médica
dc.subject.none.fl_str_mv Ribociclib
CDK4/6 inhibitor
Advanced breast cancer
Overall survival
First line
topic Ribociclib
CDK4/6 inhibitor
Advanced breast cancer
Overall survival
First line
description 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.
publishDate 2023
dc.date.none.fl_str_mv 2023
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11441/155798
https://doi.org/10.1186/s13058-023-01701-9
url https://hdl.handle.net/11441/155798
https://doi.org/10.1186/s13058-023-01701-9
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv Breast Cancer Research, 25 (1), 103.
https://breast-cancer-research.biomedcentral.com/articles/10.1186/s13058-023-01701-9
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Biomed Central LTD
publisher.none.fl_str_mv Biomed Central LTD
dc.source.none.fl_str_mv reponame:idUS. Depósito de Investigación de la Universidad de Sevilla
instname:Universidad de Sevilla (US)
instname_str Universidad de Sevilla (US)
reponame_str idUS. Depósito de Investigación de la Universidad de Sevilla
collection idUS. Depósito de Investigación de la Universidad de Sevilla
repository.name.fl_str_mv
repository.mail.fl_str_mv
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