Please use this identifier to cite or link to this item:
http://hdl.handle.net/2445/176002
Full metadata record
DC Field | Value | Language |
---|---|---|
dc.contributor.author | Martin, M. | - |
dc.contributor.author | Zielinski, C. | - |
dc.contributor.author | Ruiz Borrego, M. | - |
dc.contributor.author | Carrasco, E. | - |
dc.contributor.author | Turner, N. | - |
dc.contributor.author | Ciruelos, Eva | - |
dc.contributor.author | Muñoz Mateu, Montserrat | - |
dc.contributor.author | Bermejo de las Heras, Begoña | - |
dc.contributor.author | Margelí Vila, Mireia | - |
dc.contributor.author | Anton, A. | - |
dc.contributor.author | Kahan, Z. | - |
dc.contributor.author | Csöszi, T. | - |
dc.contributor.author | Casas, M. I. | - |
dc.contributor.author | Murillo, L. | - |
dc.contributor.author | Morales, S. | - |
dc.contributor.author | Alba, Emilio | - |
dc.contributor.author | Gal Yam, E. | - |
dc.contributor.author | Guerrero Zotano, A. | - |
dc.contributor.author | Calvo, L. | - |
dc.contributor.author | Haba Rodríguez, J. de la | - |
dc.contributor.author | Ramos, M. | - |
dc.contributor.author | Álvarez López, Isabel | - |
dc.contributor.author | García Palomo, Andrés | - |
dc.contributor.author | Huang Bartlett, C. | - |
dc.contributor.author | Koehler, M. | - |
dc.contributor.author | Caballero, R. | - |
dc.contributor.author | Corsaro, M. | - |
dc.contributor.author | Huang, X. | - |
dc.contributor.author | García Sáenz, José Ángel | - |
dc.contributor.author | Chacón, José Ignacio | - |
dc.contributor.author | Swift, C. | - |
dc.contributor.author | Thallinger, C. | - |
dc.contributor.author | Gil Gil, Miguel | - |
dc.date.accessioned | 2021-04-08T15:34:10Z | - |
dc.date.available | 2021-04-08T15:34:10Z | - |
dc.date.issued | 2021-04-01 | - |
dc.identifier.uri | http://hdl.handle.net/2445/176002 | - |
dc.description.abstract | Background: Palbociclib plus endocrine therapy (ET) is the standard treatment of hormone receptor-positive and human epidermal growth factor receptor 2-negative, metastatic breast cancer (MBC). However, its efficacy has not been compared with that of chemotherapy in a phase III trial. Patients and methods: PEARL is a multicentre, phase III randomised study in which patients with aromatase inhibitor (AI)-resistant MBC were included in two consecutive cohorts. In cohort 1, patients were randomised 1 : 1 to palbociclib plus exemestane or capecitabine. On discovering new evidence about estrogen receptor-1 (ESR1) mutations inducing resistance to AIs, the trial was amended to include cohort 2, in which patients were randomised 1 : 1 between palbociclib plus fulvestrant and capecitabine. The stratification criteria were disease site, prior sensitivity to ET, prior chemotherapy for MBC, and country of origin. Co-primary endpoints were progression-free survival (PFS) in cohort 2 and in wild-type ESR1 patients (cohort 1 + cohort 2). ESR1 hotspot mutations were analysed in baseline circulating tumour DNA. Results: From March 2014 to July 2018, 296 and 305 patients were included in cohort 1 and cohort 2, respectively. Palbociclib plus ET was not superior to capecitabine in both cohort 2 [median PFS: 7.5 versus 10.0 months; adjusted hazard ratio (aHR): 1.13; 95% confidence interval (CI): 0.85-1.50] and wild-type ESR1 patients (median PFS: 8.0 versus 10.6 months; aHR: 1.11; 95% CI: 0.87-1.41). The most frequent grade 3-4 toxicities with palbociclib plus exemestane, palbociclib plus fulvestrant and capecitabine, respectively, were neutropenia (57.4%, 55.7% and 5.5%), hand/foot syndrome (0%, 0% and 23.5%), and diarrhoea (1.3%, 1.3% and 7.6%). Palbociclib plus ET offered better quality of life (aHR for time to deterioration of global health status: 0.67; 95% CI: 0.53-0.85). Conclusions: There was no statistical superiority of palbociclib plus ET over capecitabine with respect to PFS in MBC patients resistant to AIs. Palbociclib plus ET showed a better safety profile and improved quality of life. | - |
dc.format.extent | 12 p. | - |
dc.format.mimetype | application/pdf | - |
dc.language.iso | eng | - |
dc.publisher | Elsevier B. V. | - |
dc.relation.isformatof | Reproducció del document publicat a: https://doi.org/10.1016/j.annonc.2020.12.013 | - |
dc.relation.ispartof | Annals of Oncology, 2021, vol. 32, num. 4, p. 488-499 | - |
dc.relation.uri | https://doi.org/10.1016/j.annonc.2020.12.013 | - |
dc.rights | cc by-nc-nd (c) Martin et al., 2020 | - |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/3.0/es/ | * |
dc.source | Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) | - |
dc.subject.classification | Càncer de mama | - |
dc.subject.classification | Hormonoteràpia | - |
dc.subject.other | Breast cancer | - |
dc.subject.other | Hormone therapy | - |
dc.title | Palbociclib in combination with endocrine therapy versus capecitabine in hormonal receptor-positive, human epidermal growth factor 2-negative, aromatase inhibitor-resistant metastatic breast cancer: a phase III randomised controlled trial—PEARL | - |
dc.type | info:eu-repo/semantics/article | - |
dc.type | info:eu-repo/semantics/publishedVersion | - |
dc.date.updated | 2021-04-08T06:49:45Z | - |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | - |
dc.identifier.pmid | 33385521 | - |
Appears in Collections: | Articles publicats en revistes (IDIBAPS: Institut d'investigacions Biomèdiques August Pi i Sunyer) Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL)) |
Files in This Item:
File | Description | Size | Format | |
---|---|---|---|---|
PIIS0923753420432211.pdf | 529.14 kB | Adobe PDF | View/Open |
This item is licensed under a Creative Commons License