التفاصيل البيبلوغرافية
| العنوان: |
Quality of life with palbociclib plus fulvestrant versus placebo plus fulvestrant in postmenopausal women with endocrine-sensitive hormone receptor-positive and HER2-negative advanced breast cancer: patient-reported outcomes from the FLIPPER trial |
| المؤلفون: |
Tibau, Ariadna, Martínez, M. Teresa, Ramos, Manuel, Cruz Merino, Luis de la, Santaballa, Ana, O’Connor, Miriam, Albanell, Joan |
| المساهمون: |
Universidad de Sevilla. Departamento de Medicina, Universidad de Sevilla. CTS151: Bioquímica médica. |
| بيانات النشر: |
Sage Journals |
| سنة النشر: |
2024 |
| المجموعة: |
idUS - Deposito de Investigación Universidad de Sevilla |
| مصطلحات موضوعية: |
Advanced breast cancer, CDK4/6 inhibitor, Fulvestrant, Palbociclib, Patient reported outcomes, Quality of life |
| الوصف: |
Background: In the FLIPPER trial, palbociclib/fulvestrant significantly improved progression free survival (PFS) compared with placebo/fulvestrant in postmenopausal women with HR+/ HER2− advanced breast cancer (ABC). Objective: We assessed health-related quality of life (QoL) using patient-reported outcomes (PROs). Design and methods: In this phase II double-blinded study, PROs were assessed at baseline after every three cycles and at the end of the treatment using the European Organisation for Research and Treatment of Cancer QLQ-C30 and QLQ-BR23. Time to deterioration (TTD) in global health status (GHS)/QoL was defined as a decrease of ⩾10points. Changes from baseline (CFB) and TTD were analysed using linear mixed-effect and Cox regression models, respectively. Results: Of the 189 randomised (1:1) patients, 178 (94%) completed ⩾1 post-baseline assessment; 50% received ⩾22 cycles of study treatment, with a questionnaire compliance >90%. Mean baseline scores were comparable between arms. GHS/QoL scores were maintained throughout the palbociclib/fulvestrant treatment. CFB showed significant differences for GHS/QoL, appetite loss, constipation and systemic therapy side effect scores favouring placebo/fulvestrant. TTD in GHS/QoL was delayed in placebo/fulvestrant versus palbociclib/fulvestrant [30.3 versus 11.1months; adjusted hazard ratio (aHR): 1.57, 95% CI: 1.03–2.39, p=0.036]; this difference was not significant in patients with progressive disease (aHR: 1.2, 95% CI: 0.6–2.2, p=0.658). No statistically significant differences in TTD were found for the other QLQ-C30 and QLQ-BR23 scales. Conclusions: Although TTD in GHS/QoL was prolonged with placebo/fulvestrant, no differences were observed on other functional or symptom scales. This finding and the improvement in PFS support the combination of palbociclib/fulvestrant as a beneficial therapeutic option for HR+/HER2− ABC. |
| نوع الوثيقة: |
article in journal/newspaper |
| اللغة: |
English |
| العلاقة: |
herapeutic Advances in Medical Oncology, 15, 17588359221148921.; https://idus.us.es/handle//11441/155769Test |
| الإتاحة: |
https://idus.us.es/handle//11441/155769Test |
| حقوق: |
Attribution-NoDerivatives 4.0 Internacional ; http://creativecommons.org/licenses/by-nd/4.0Test/ ; info:eu-repo/semantics/openAccess |
| رقم الانضمام: |
edsbas.6EB4938B |
| قاعدة البيانات: |
BASE |
