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

Kahan, Z. ; Gil-Gil, M. ; Ruiz-Borrego, M. ; Carrasco, E. ; Ciruelos, E. ; Muñoz, M. ; Bermejo, B. ; Margeli, M. ; Antón, A. (Universidad de Zaragoza) ; Casas, M. ; Csöszi, T. ; Murillo, L. ; Morales, S. ; Calvo, L. ; Lang, I. ; Alba, E. ; Haba-Rodriguez J. de la ; Ramos, M. ; Álvarez López, I. ; Gal-Yam, E. ; García-Palomo, A. ; Álvarez, E. ; González-Santiago, S. ; Rodríguez, C. A. ; Servitja, S. ; Corsaro, M. ; Rodrigálvarez, G. ; Zielinski, C. ; Martín, M.

Resumen: 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. © 2021 The Author(s)

Idioma: Inglés

DOI: 10.1016/j.ejca.2021.07.004

Año: 2021

Publicado en: European Journal of Cancer 156 (2021), 70-82
ISSN: 0959-8049

Factor impacto JCR: 10.002 (2021)

Categ. JCR: ONCOLOGY rank: 31 / 245 = 0.127 (2021) - Q1 - T1

Factor impacto CITESCORE: 12.4 - Medicine (Q1) - Biochemistry, Genetics and Molecular Biology (Q1)

Factor impacto SCIMAGO: 2.865 - Oncology (Q1) - Cancer Research (Q1)

Tipo y forma: Article (Published version)

Área (Departamento): Area Medicina (Dpto. Medicina, Psiqu. y Derm.)