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
Tibau Martorell, Ariadna (Institut d'Investigació Biomèdica Sant Pau)
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 Rafael
Sánchez-Rovira, Pedro
Albacar, Cinta Rosa
Bueno Muiño, Coralia
Kelly, Catherine
Casas, Maribel
Bezares, Susana
Rosell, Libertad
Albanell Mestres, Joan (Hospital del Mar (Barcelona, Catalunya))
Universitat Autònoma de Barcelona

Data:	2023
Resum:	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). We assessed health-related quality of life (QoL) using patient-reported outcomes (PROs). 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. 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. 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. Sponsor Study Code: GEICAM/2014-12 EudraCT Number: 2015-002437-21 ClinTrials. gov reference: NCT02690480.
Drets:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original.
Llengua:	Anglès
Document:	Article ; recerca ; Versió publicada
Matèria:	Advanced breast cancer ; CDK4/6 inhibitor ; Fulvestrant ; Palbociclib ; Patient-reported outcomes ; Quality of life
Publicat a:	Therapeutic Advances in Medical Oncology, Vol. 15 (january 2023) , ISSN 1758-8359

DOI: 10.1177/17588359221148921
PMID: 36743520

14 p, 2.0 MB

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