Publication:
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

Thumbnail Image
Files
1-s2.0-S0959804922001460-main.pdf(2.51 MB)
Date
2022-04-13
relationships.isAuthorOfPublication
relationships.isSecondaryAuthorOf
relationships.isDirectorOf
Authors
Martín, Miguel ; Zielinski, Christoph ; Ruiz-Borrego, Manuel ; Carrasco, Eva ; Ciruelos, Eva M. ; Muñoz, Montserrat ; Bermejo, Begoña ; Margelí, Mireia ; Csöszi, Tibor ; Anton, Antonio ; Turner, Nicholas ; Casas, María I. ; Morales, Serafín ; Alba, Emilio ; Calvo, Lourdes ; Haba-Rodríguez, Juan de la ; Ramos, Manuel ; Murillo, Laura ; Corsaro, Massimo ; Xin, Huang ; Thallinger, Christiane ; Kahan, Zsuzsanna ; Gil-Gil, Miguel
item.page.secondaryauthor
item.page.director
Publisher
Elsevier
publication.page.editor
publication.page.department
Medicina
DOI
https://doi.org/10.1016/j.ejca.2022.03.006
item.page.type
info:eu-repo/semantics/article
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
Abstract
Background: 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.
publication.page.subject
CDK4/6 inhibitor , Palbociclib , Endocrine therapy , Hormone receptor positive metastatic breast cancer , Overall survival , Capecitabine , HER2-negative
Citation
European Journal of Cancer, 168 (2022) 12-24
URI
http://hdl.handle.net/10201/145997
item.page.embargo
Collections
Artículos
Ir a Estadísticas