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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• dc.contributor.author Tibau, Ariadna
• dc.contributor.author Martínez, María Teresa
• dc.contributor.author Ramos, Manuel
• dc.contributor.author Cruz-Merino, Luis
• dc.contributor.author Santaballa, Ana
• dc.contributor.author O'Connor, Miriam
• dc.contributor.author Martínez-Jáñez, Noelia
• dc.contributor.author Moreno, Fernando
• dc.contributor.author Fernández, Isaura
• dc.contributor.author Virizuela, Juan Antonio
• dc.contributor.author Alarcón, Jesús
• dc.contributor.author Haba Rodríguez, Juan de la
• dc.contributor.author Sánchez-Rovira, Pedro
• dc.contributor.author Albacar, Cinta Rosa
• dc.contributor.author Bueno Muiño, Carolia
• dc.contributor.author Kelly, Catherine
• dc.contributor.author Casas Sanahuja, Maribel
• dc.contributor.author Bezares, Susana
• dc.contributor.author Rosell, Libertad
• dc.contributor.author Albanell Mestres, Joan
• dc.date.accessioned 2023-09-26T06:31:06Z
• dc.date.available 2023-09-26T06:31:06Z
• dc.date.issued 2023
• dc.description.abstract 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/2014-12EudraCT Number: 2015-002437-21ClinTrials.gov reference: NCT02690480.
• dc.format.mimetype application/pdf
• dc.identifier.citation Tibau A, Martínez MT, Ramos M, De La Cruz-Merino L, Santaballa A, O’Connor M, Martínez-Jañez N, Moreno F, Fernández I, Virizuela JA, Alarcón J, de La Haba-Rodríguez J, Sánchez-Rovira P, Albacar CR, Bueno Muiño C, Kelly C, Casas M, Bezares S, Rosell L, Albanell J. 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. Ther Adv Med Oncol. 2023 Jan 19;15:17588359221148921. DOI: 10.1177/17588359221148921
• dc.identifier.doi http://dx.doi.org/10.1177/17588359221148921
• dc.identifier.issn 1758-8340
• dc.identifier.uri http://hdl.handle.net/10230/57954
• dc.language.iso eng
• dc.publisher SAGE Publications
• dc.relation.ispartof Ther Adv Med Oncol. 2023 Jan 19;15:17588359221148921
• dc.rights © The Author(s), 2023. This article is distributed under the terms of the Creative Commons Attribution-NonCommercial 4.0 License (https://creativecommons.org/licenses/by-nc/4.0/) which permits non-commercial use, reproduction and distribution of the work without further permission provided the original work is attributed as specified on the SAGE and Open Access page (https://us.sagepub.com/en-us/nam/open-access-at-sage).
• dc.rights.accessRights info:eu-repo/semantics/openAccess
• dc.rights.uri http://creativecommons.org/licenses/by-nc/4.0/
• dc.subject.keyword CDK4/6 inhibitor
• dc.subject.keyword Advanced breast cancer
• dc.subject.keyword Fulvestrant
• dc.subject.keyword Palbociclib
• dc.subject.keyword Patient-reported outcomes
• dc.subject.keyword Quality of life
• dc.title 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
• dc.type info:eu-repo/semantics/article
• dc.type.version info:eu-repo/semantics/publishedVersion