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Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study

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dc.contributor.authorMartín, Miguel
dc.contributor.authorZielinski, Christoph
dc.contributor.authorRuiz-Borrego, Manuel
dc.contributor.authorCarrasco, Eva
dc.contributor.authorCiruelos, Eva M.
dc.contributor.authorMuñoz, Montserrat
dc.contributor.authorBermejo, Begoña
dc.contributor.authorMargelí, Mireia
dc.contributor.authorCsöszi, Tibor
dc.contributor.authorAnton, Antonio
dc.contributor.authorTurner, Nicholas
dc.contributor.authorCasas, María I.
dc.contributor.authorMorales, Serafín
dc.contributor.authorAlba, Emilio
dc.contributor.authorCalvo, Lourdes
dc.contributor.authorHaba-Rodríguez, Juan de la
dc.contributor.authorRamos, Manuel
dc.contributor.authorMurillo, Laura
dc.contributor.authorCorsaro, Massimo
dc.contributor.authorXin, Huang
dc.contributor.authorThallinger, Christiane
dc.contributor.authorKahan, Zsuzsanna
dc.contributor.authorGil-Gil, Miguel
dc.contributor.departmentMedicina
dc.date.accessioned2024-11-05T12:08:58Z
dc.date.available2024-11-05T12:08:58Z
dc.date.issued2022-04-13
dc.description© 2022 The Author(s). This manuscript version is made available under the CC-BY-NC-ND 4.0 license http://creativecommons.org/licenses/by-nc-nd/4.0/. This document is the Published version of a Published Work that appeared in final form in European Journal of Cancer. To access the final edited and published work see https://doi.org/10.1016/j.ejca.2022.03.006
dc.description.abstractBackground: An earlier analysis of the PEARL phase III study showed that palbociclib plus endocrine therapy (ET) does not improve progression-free survival (PFS) over capecitabine in aromatase inhibitor-resistant, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (MBC) patients. Here, we report the final overall survival (OS) analysis. Methods: Postmenopausal patients (N = 601) were randomized 1:1 to capecitabine or palbociclib plus ET (exemestane, Cohort 1; fulvestrant, Cohort 2). OS was analysed in Cohort 2, the wild-type ESR1 population and the overall population. Additionally, we analysed subsequent systemic therapies and explored PFS2 (time from randomization to the end of the first subsequent therapy/death). Results: OS was 31.1 months for palbociclib plus fulvestrant and 32.8 months for capecitabine (adjusted hazard ratio [aHR] 1.10, 95% confidence interval [CI] 0.81–1.50, P = 0.550). In the wild-type ESR1 population, OS was 37.2 months for palbociclib plus ET and 34.8 months for capecitabine (aHR 1.06, 95% CI 0.81–1.37, P = 0.683). In OS analyses, no subgroup showed superiority for palbociclib plus ET over capecitabine. OS in the overall population was 32.6 months for palbociclib plus ET and 30.9 months for capecitabine (P = 0.995). Subsequent systemic therapy was given to 79.8% and 82.9% of patients with palbociclib plus ET and capecitabine, respectively. Median PFS2 was similar between study arms (Cohort 2, P = 0.941; wild-type ESR1 population, P = 0.827). No new safety findings were observed. Conclusions: Palbociclib plus ET did not show a statistically superior OS compared to capecitabine in MBC patients progressing on aromatase inhibitors.es
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dc.format.extent13es
dc.identifier.citationEuropean Journal of Cancer, 168 (2022) 12-24
dc.identifier.doihttps://doi.org/10.1016/j.ejca.2022.03.006
dc.identifier.issnPrint: 0959-8049
dc.identifier.issnElectronic: 1879-0852
dc.identifier.urihttp://hdl.handle.net/10201/145997
dc.languageenges
dc.publisherElsevier
dc.relationSin financiación externa a la Universidades
dc.relation.publisherversionhttps://www.sciencedirect.com/science/article/pii/S0959804922001460?via%3Dihub
dc.rightsinfo:eu-repo/semantics/openAccesses
dc.rightsAttribution-NonCommercial-NoDerivatives 4.0 Internacional*
dc.rights.urihttp://creativecommons.org/licenses/by-nc-nd/4.0/*
dc.subjectCDK4/6 inhibitores
dc.subjectPalbociclibes
dc.subjectEndocrine therapyes
dc.subjectHormone receptor positive metastatic breast canceres
dc.subjectOverall survivales
dc.subjectCapecitabinees
dc.subjectHER2-negativees
dc.titleOverall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL studyes
dc.typeinfo:eu-repo/semantics/articlees
dspace.entity.typePublicationes
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