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.
In: Therapeutic Advances in Medical Oncology, 2023-01-19, S. 1-14
Online
academicJournal
Zugriff:
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 ⩾10 points. 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 11.1 months; 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. Trial registration number: Sponsor Study Code: GEICAM/2014-12 EudraCT Number: 2015-002437-21 ClinTrials.gov reference: NCT02690480 [ABSTRACT FROM AUTHOR]
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Titel: |
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.
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Autor/in / Beteiligte Person: | Tibau, Ariadna ; Martínez, M. Teresa ; Ramos, Manuel ; De La Cruz-Merino, Luis ; Santaballa, Ana ; O'Connor, Miriam ; Martínez-Jañez, Noelia ; Moreno, Fernando ; Fernández, Isaura ; Virizuela, Juan Antonio ; Alarcón, Jesús ; de La Haba-Rodríguez, Juan ; Sánchez-Rovira, Pedro ; Albacar, Cinta Rosa ; Bueno Muiño, Coralia ; Kelly, Catherine ; Casas, Maribel ; Bezares, Susana ; Rosell, Libertad ; Albanell, Joan |
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Zeitschrift: | Therapeutic Advances in Medical Oncology, 2023-01-19, S. 1-14 |
Veröffentlichung: | 2023 |
Medientyp: | academicJournal |
ISSN: | 1758-8340 (print) |
DOI: | 10.1177/17588359221148921 |
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