%0 Journal Article
%A Kahan, Zsuzsanna
%A Gil-Gil, Miguel
%A Ruiz-Borrego, Manuel
%A Carrasco, Eva
%A Ciruelos, Eva
%A Muñoz, Montserrat
%A Bermejo, Begoña
%A Margeli, Mireia
%A Anton, Antonio
%A Casas, Maribel
%A Csoszi, Tibor
%A Murillo, Laura
%A Morales, Serafin
%A Calvo, Lourdes
%A Lang, Istvan
%A Alba, Emilio
%A de-la-Haba-Rodriguez, Juan
%A Ramos, Manuel
%A Alvarez-Lopez, Isabel 
%A Gal-Yam, Einav
%A Garcia-Palomo, Andres
%A Alvarez, Elena
%A Gonzalez-Santiago, Santiago
%A Rodriguez, Cesar A
%A Servitja, Sonia
%A Corsaro, Massimo
%A Rodrigalvarez, Graciela
%A Zielinski, Christoph
%A Martin, Miguel
%T 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.
%D 2021
%U http://hdl.handle.net/10668/18401
%X 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. 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. 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. 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. 
%K CDK4/6 inhibitor
%K Endocrine therapy
%K Health-related quality of life
%K Hormone receptor–positive metastatic breast cancer
%K Palbociclib
%~