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

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...

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Autores: Tibau, Ariadna, Martínez, M. Teresa, Ramos, Manuel, Cruz Merino, Luis de la, Santaballa, Ana, O’Connor, Miriam, Albanell, Joan
Formato: artículo
Estado:Versión publicada
Fecha de publicación:2023
País:España
Recursos:Universidad de Sevilla (US)
Repositorio:idUS. Depósito de Investigación de la Universidad de Sevilla
OAI Identifier:oai:idus.us.es:11441/155769
Acesso em linha:https://hdl.handle.net/11441/155769
https://doi.org/0.1177/17588359221148921
Access Level:acceso abierto
Palavra-chave:Advanced breast cancer
CDK4/6 inhibitor
Fulvestrant
Palbociclib
Patient reported outcomes
Quality of life
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spelling 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 trialTibau, AriadnaMartínez, M. TeresaRamos, ManuelCruz Merino, Luis de laSantaballa, AnaO’Connor, MiriamAlbanell, JoanAdvanced breast cancerCDK4/6 inhibitorFulvestrantPalbociclibPatient reported outcomesQuality of lifeBackground: 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.Sage JournalsMedicinaCTS151: Bioquímica médica2023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttps://hdl.handle.net/11441/155769https://doi.org/0.1177/17588359221148921reponame:idUS. Depósito de Investigación de la Universidad de Sevillainstname:Universidad de Sevilla (US)Inglésherapeutic Advances in Medical Oncology, 15, 17588359221148921.https://journals.sagepub.com/doi/10.1177/17588359221148921info:eu-repo/semantics/openAccessoai:idus.us.es:11441/1557692026-06-17T12:51:07Z
dc.title.none.fl_str_mv 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
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
spellingShingle 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, Ariadna
Advanced breast cancer
CDK4/6 inhibitor
Fulvestrant
Palbociclib
Patient reported outcomes
Quality of life
title_short 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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_sort 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.creator.none.fl_str_mv Tibau, Ariadna
Martínez, M. Teresa
Ramos, Manuel
Cruz Merino, Luis de la
Santaballa, Ana
O’Connor, Miriam
Albanell, Joan
author Tibau, Ariadna
author_facet Tibau, Ariadna
Martínez, M. Teresa
Ramos, Manuel
Cruz Merino, Luis de la
Santaballa, Ana
O’Connor, Miriam
Albanell, Joan
author_role author
author2 Martínez, M. Teresa
Ramos, Manuel
Cruz Merino, Luis de la
Santaballa, Ana
O’Connor, Miriam
Albanell, Joan
author2_role author
author
author
author
author
author
dc.contributor.none.fl_str_mv Medicina
CTS151: Bioquímica médica
dc.subject.none.fl_str_mv Advanced breast cancer
CDK4/6 inhibitor
Fulvestrant
Palbociclib
Patient reported outcomes
Quality of life
topic Advanced breast cancer
CDK4/6 inhibitor
Fulvestrant
Palbociclib
Patient reported outcomes
Quality of life
description 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.
publishDate 2023
dc.date.none.fl_str_mv 2023
dc.type.none.fl_str_mv info:eu-repo/semantics/article
info:eu-repo/semantics/publishedVersion
format article
status_str publishedVersion
dc.identifier.none.fl_str_mv https://hdl.handle.net/11441/155769
https://doi.org/0.1177/17588359221148921
url https://hdl.handle.net/11441/155769
https://doi.org/0.1177/17588359221148921
dc.language.none.fl_str_mv Inglés
language_invalid_str_mv Inglés
dc.relation.none.fl_str_mv herapeutic Advances in Medical Oncology, 15, 17588359221148921.
https://journals.sagepub.com/doi/10.1177/17588359221148921
dc.rights.none.fl_str_mv info:eu-repo/semantics/openAccess
eu_rights_str_mv openAccess
dc.format.none.fl_str_mv application/pdf
application/pdf
dc.publisher.none.fl_str_mv Sage Journals
publisher.none.fl_str_mv Sage Journals
dc.source.none.fl_str_mv reponame:idUS. Depósito de Investigación de la Universidad de Sevilla
instname:Universidad de Sevilla (US)
instname_str Universidad de Sevilla (US)
reponame_str idUS. Depósito de Investigación de la Universidad de Sevilla
collection idUS. Depósito de Investigación de la Universidad de Sevilla
repository.name.fl_str_mv
repository.mail.fl_str_mv
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