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
Martín, Miguel ; Zielinski, Christoph ; Ruiz-Borrego, Manuel ; Carrasco, Eva ; Ciruelos, Eva M. ; Muñoz, Montserrat ; Bermejo, Begoña ; Margelí, Mireia ; Csöszi, Tibor ; Antón, Antonio (Universidad de Zaragoza) ; Turner, Nicholas ; Casas, María I. ; Morales, Serafín ; Alba, Emilio ; Calvo, Lourdes ; de la Haba-Rodríguez, Juan ; Ramos, Manuel ; Murillo, Laura ; Santaballa, Ana ; Alonso-Romero, José L. ; Sánchez-Rovira, Pedro ; Corsaro, Massimo ; Huang, Xin ; Thallinger, Christiane ; Kahan, Zsuzsanna ; Gil-Gil, Miguel
Resumen: 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.
Trial registration
NCT02028507 (ClinTrials.gov), 2013-003170-27 (EudraCT).
Idioma: Inglés
DOI: 10.1016/j.ejca.2022.03.006
Año: 2022
Publicado en: European Journal of Cancer 168 (2022), 12-24
ISSN: 0959-8049
Factor impacto JCR: 8.4 (2022)
Categ. JCR: ONCOLOGY rank: 37 / 241 = 0.154 (2022) - Q1 - T1
Factor impacto CITESCORE: 11.1 - Medicine (Q1) - Biochemistry, Genetics and Molecular Biology (Q1)
Factor impacto SCIMAGO: 2.898 - Oncology (Q1) - Cancer Research (Q1)
Tipo y forma: Artículo (Versión definitiva)
Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)
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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.
Trial registration
NCT02028507 (ClinTrials.gov), 2013-003170-27 (EudraCT).
Idioma: Inglés
DOI: 10.1016/j.ejca.2022.03.006
Año: 2022
Publicado en: European Journal of Cancer 168 (2022), 12-24
ISSN: 0959-8049
Factor impacto JCR: 8.4 (2022)
Categ. JCR: ONCOLOGY rank: 37 / 241 = 0.154 (2022) - Q1 - T1
Factor impacto CITESCORE: 11.1 - Medicine (Q1) - Biochemistry, Genetics and Molecular Biology (Q1)
Factor impacto SCIMAGO: 2.898 - Oncology (Q1) - Cancer Research (Q1)
Tipo y forma: Artículo (Versión definitiva)
Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)
Debe reconocer adecuadamente la autoría, proporcionar un enlace a la licencia e indicar si se han realizado cambios. Puede hacerlo de cualquier manera razonable, pero no de una manera que sugiera que tiene el apoyo del licenciador o lo recibe por el uso que hace. No puede utilizar el material para una finalidad comercial. Si remezcla, transforma o crea a partir del material, no puede difundir el material modificado.Exportado de SIDERAL (2025-10-17-14:35:13)
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