110834 20230519145621.0 doi 10.1016/j.ejca.2021.07.004 sideral 127568 ART-2021-127568 eng Kahan, Z. 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 2021 Access copy available to the general public Unrestricted 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) info:eu-repo/semantics/openAccess by-nc-nd http://creativecommons.org/licenses/by-nc-nd/3.0/es/ 10.002 2021 ONCOLOGY 31 / 245 = 0.127 2021 Q1 T1 2.865 2021 Oncology 2021 Q1 Cancer Research 2021 Q1 12.4 2021 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Gil-Gil, M. Ruiz-Borrego, M. Carrasco, E. Ciruelos, E. Muñoz, M. Bermejo, B. Margeli, M. Antón, A. Universidad de Zaragoza (orcid)0000-0002-9159-4988 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. 1007 610 Universidad de Zaragoza Dpto. Medicina, Psiqu. y Derm. Area Medicina 156 (2021), 70-82 Eur. j. cancer European Journal of Cancer 0959-8049 1044517 http://zaguan.unizar.es/record/110834/files/texto_completo.pdf Versión publicada 2076542 http://zaguan.unizar.es/record/110834/files/texto_completo.jpg?subformat=icon icon Versión publicada oai:zaguan.unizar.es:110834 articulos driver 2023-05-18-16:15:45 ARTICLE