000110834 001__ 110834 000110834 005__ 20230519145621.0 000110834 0247_ $$2doi$$a10.1016/j.ejca.2021.07.004 000110834 0248_ $$2sideral$$a127568 000110834 037__ $$aART-2021-127568 000110834 041__ $$aeng 000110834 100__ $$aKahan, Z. 000110834 245__ $$aHealth-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 000110834 260__ $$c2021 000110834 5060_ $$aAccess copy available to the general public$$fUnrestricted 000110834 5203_ $$aBackground: 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) 000110834 540__ $$9info:eu-repo/semantics/openAccess$$aby-nc-nd$$uhttp://creativecommons.org/licenses/by-nc-nd/3.0/es/ 000110834 590__ $$a10.002$$b2021 000110834 592__ $$a2.865$$b2021 000110834 594__ $$a12.4$$b2021 000110834 591__ $$aONCOLOGY$$b31 / 245 = 0.127$$c2021$$dQ1$$eT1 000110834 593__ $$aOncology$$c2021$$dQ1 000110834 593__ $$aCancer Research$$c2021$$dQ1 000110834 655_4 $$ainfo:eu-repo/semantics/article$$vinfo:eu-repo/semantics/publishedVersion 000110834 700__ $$aGil-Gil, M. 000110834 700__ $$aRuiz-Borrego, M. 000110834 700__ $$aCarrasco, E. 000110834 700__ $$aCiruelos, E. 000110834 700__ $$aMuñoz, M. 000110834 700__ $$aBermejo, B. 000110834 700__ $$aMargeli, M. 000110834 700__ $$0(orcid)0000-0002-9159-4988$$aAntón, A.$$uUniversidad de Zaragoza 000110834 700__ $$aCasas, M. 000110834 700__ $$aCsöszi, T. 000110834 700__ $$aMurillo, L. 000110834 700__ $$aMorales, S. 000110834 700__ $$aCalvo, L. 000110834 700__ $$aLang, I. 000110834 700__ $$aAlba, E. 000110834 700__ $$aHaba-Rodriguez J. de la 000110834 700__ $$aRamos, M. 000110834 700__ $$aÁlvarez López, I. 000110834 700__ $$aGal-Yam, E. 000110834 700__ $$aGarcía-Palomo, A. 000110834 700__ $$aÁlvarez, E. 000110834 700__ $$aGonzález-Santiago, S. 000110834 700__ $$aRodríguez, C. A. 000110834 700__ $$aServitja, S. 000110834 700__ $$aCorsaro, M. 000110834 700__ $$aRodrigálvarez, G. 000110834 700__ $$aZielinski, C. 000110834 700__ $$aMartín, M. 000110834 7102_ $$11007$$2610$$aUniversidad de Zaragoza$$bDpto. Medicina, Psiqu. y Derm.$$cArea Medicina 000110834 773__ $$g156 (2021), 70-82$$pEur. j. cancer$$tEuropean Journal of Cancer$$x0959-8049 000110834 8564_ $$s1044517$$uhttps://zaguan.unizar.es/record/110834/files/texto_completo.pdf$$yVersión publicada 000110834 8564_ $$s2076542$$uhttps://zaguan.unizar.es/record/110834/files/texto_completo.jpg?subformat=icon$$xicon$$yVersión publicada 000110834 909CO $$ooai:zaguan.unizar.es:110834$$particulos$$pdriver 000110834 951__ $$a2023-05-18-16:15:45 000110834 980__ $$aARTICLE