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: Article (Published version)
Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)
You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use. You may not use the material for commercial purposes. If you remix, transform, or build upon the material, you may not distribute the modified material.
Exportado de SIDERAL (2025-10-17-14:35:13)
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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: Article (Published version)
Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)
You must give appropriate credit, provide a link to the license, and indicate if changes were made. You may do so in any reasonable manner, but not in any way that suggests the licensor endorses you or your use. You may not use the material for commercial purposes. If you remix, transform, or build upon the material, you may not distribute the modified material. Exportado de SIDERAL (2025-10-17-14:35:13)
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Record created 2025-02-03, last modified 2025-10-17