Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer: Patient-reported outcomes in the PEARL study.

BACKGROUND: The PEARL study showed that palbociclib plus endocrine therapy (palbociclib/ET) was not superior to capecitabine in improving progression-free survival in postmenopausal patients with metastatic breast cancer resistant to aromatase inhibitors, but was better tolerated. This analysis comp...

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Detalles Bibliográficos
Autores: Kahan, Zsuzsanna, Gil-Gil, Miguel, Ruiz-Borrego, Manuel, Carrasco, Eva, Ciruelos, Eva, Munoz, Montserrat, Bermejo, Begona, Margeli, Mireia, Anton, Antonio, Casas, Maribel, Csoszi, Tibor, Murillo, Laura, Morales, Serafin, Calvo, Lourdes, Lang, Istvan, Alba, Emilio, de la Haba-Rodriguez, Juan, Ramos, Manuel, Lopez, Isabel Alvarez, Gal-Yam, Einav, Garcia-Palomo, Andres, Alvarez, Elena, Gonzalez-Santiago, Santiago, Rodriguez, Cesar A, Servitja, Sonia, Corsaro, Massimo, Rodrigalvarez, Graciela, Zielinski, Christoph, Martin, Miguel
Tipo de recurso: artículo
Estado:Versión publicada
Fecha de publicación:2021
País:España
Institución:INCLIVA
Repositorio:r-INCLIVA. Repositorio Institucional de Producción Científica de INCLIVA
OAI Identifier:oai:incliva.fundanetsuite.com:p15912
Acceso en línea:https://incliva.portalinvestigacion.com/publicaciones/15912
Access Level:acceso abierto
Palabra clave:CDK4/6 inhibitor
Endocrine therapy
Health-related quality of life
Hormone receptor–positive metastatic breast cancer
Palbociclib
Descripción
Sumario:BACKGROUND: The PEARL study showed that palbociclib plus endocrine therapy (palbociclib/ET) was not superior to capecitabine in improving progression-free survival in postmenopausal patients with metastatic breast cancer resistant to aromatase inhibitors, but was better tolerated. This analysis compared patient-reported outcomes. PATIENTS AND METHODS: The PEARL quality of life (QoL) population comprised 537 patients, 268 randomised to palbociclib/ET (exemestane or fulvestrant) and 269 to capecitabine. Patients completed the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR23 and EQ-5D-3L questionnaires. Changes from the baseline and time to deterioration (TTD) were analysed using linear mixed-effect and stratified Cox regression models, respectively. RESULTS: Questionnaire completion rate was high and similar between treatment arms. Significant differences were observed in the mean change in global health status (GHS)/QoL scores from the baseline to cycle 3 (2.9 for palbociclib/ET vs. -2.1 for capecitabine (95% confidence interval [CI], 1.4-8.6; P = 0.007). The median TTD in GHS/QoL was 8.3 months for palbociclib/ET versus 5.3 months for capecitabine (adjusted hazard ratio, 0.70; 95% CI, 0.55-0.89; P = 0.003). Similar improvements for palbociclib/ET were also seen for other scales as physical, role, cognitive, social functioning, fatigue, nausea/vomiting and appetite loss. No differences were observed between the treatment arms in change from the baseline in any item of the EQ-5D-L3 questionnaire as per the overall index score and visual analogue scale. CONCLUSION: Patients receiving palbociclib/ET experienced a significant delay in deterioration of GHS/QoL and several functional and symptom scales compared with capecitabine, providing additional evidence that palbociclib/ET is better tolerated. TRIAL REGISTRATION NUMBER: NCT02028507 (ClinTrials.gov). EUDRACT STUDY NUMBER: 2013-003170-27.

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