TY - JOUR
T1 - Health-related quality of life with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive metastatic breast cancer
T2 - Patient-reported outcomes in the PEARL study
AU - Kahan, Zsuzsanna
AU - Gil-Gil, Miguel
AU - Ruiz-Borrego, Manuel
AU - Carrasco, Eva
AU - Ciruelos, Eva
AU - Muñoz, Montserrat
AU - Bermejo, Begoña
AU - Margeli, Mireia
AU - Antón, Antonio
AU - Casas, Maribel
AU - Csöszi, Tibor
AU - Murillo, Laura
AU - Morales, Serafín
AU - Calvo, Lourdes
AU - Lang, Istvan
AU - Alba, Emilio
AU - de la Haba-Rodriguez, Juan
AU - Ramos, Manuel
AU - López, Isabel Álvarez
AU - Gal-Yam, Einav
AU - Garcia-Palomo, Andrés
AU - Alvarez, Elena
AU - González-Santiago, Santiago
AU - Rodríguez, César A
AU - Servitja, Sonia
AU - Corsaro, Massimo
AU - Rodrigálvarez, Graciela
AU - Zielinski, Christoph
AU - Martín, Miguel
N1 - Copyright © 2021 The Author(s). Published by Elsevier Ltd.. All rights reserved.
PY - 2021/10
Y1 - 2021/10
N2 - 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.
AB - 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.
KW - Androstadienes/therapeutic use
KW - Antimetabolites, Antineoplastic/adverse effects
KW - Antineoplastic Agents, Hormonal/adverse effects
KW - Antineoplastic Combined Chemotherapy Protocols/adverse effects
KW - Aromatase Inhibitors/therapeutic use
KW - Breast Neoplasms/chemistry
KW - Capecitabine/adverse effects
KW - Disease Progression
KW - Estrogen Receptor Antagonists/therapeutic use
KW - Europe
KW - Female
KW - Fulvestrant/therapeutic use
KW - Health Status
KW - Humans
KW - Israel
KW - Neoplasm Metastasis
KW - Patient Reported Outcome Measures
KW - Piperazines/adverse effects
KW - Postmenopause
KW - Progression-Free Survival
KW - Protein Kinase Inhibitors/adverse effects
KW - Pyridines/adverse effects
KW - Quality of Life
KW - Time Factors
U2 - 10.1016/j.ejca.2021.07.004
DO - 10.1016/j.ejca.2021.07.004
M3 - Article
C2 - 34425406
SN - 0959-8049
VL - 156
SP - 70
EP - 82
JO - European Journal of Cancer
JF - European Journal of Cancer
ER -
