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 o...
| Autores: | , , , , , , , , , , , , , , , , , , , |
|---|---|
| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2023 |
| País: | España |
| Institución: | Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
| Repositorio: | Recercat. Dipósit de la Recerca de Catalunya |
| OAI Identifier: | oai:recercat.cat:10230/57954 |
| Acceso en línea: | http://hdl.handle.net/10230/57954 http://dx.doi.org/10.1177/17588359221148921 |
| Access Level: | acceso abierto |
| Palabra clave: | CDK4/6 inhibitor Advanced breast cancer Fulvestrant Palbociclib Patient-reported outcomes Quality of life |
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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, María TeresaRamos, ManuelCruz-Merino, LuisSantaballa, AnaO'Connor, MiriamMartínez-Jáñez, NoeliaMoreno, FernandoFernández, IsauraVirizuela, Juan AntonioAlarcón, JesúsHaba-Rodríguez, Juan de laSánchez-Rovira, PedroAlbacar, Cinta RosaBueno Muiño, CaroliaKelly, CatherineCasas Sanahuja, MaribelBezares, SusanaRosell, LibertadAlbanell Mestres, JoanCDK4/6 inhibitorAdvanced breast cancerFulvestrantPalbociclibPatient-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 ⩾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.SAGE Publications202320232023info:eu-repo/semantics/articleinfo:eu-repo/semantics/publishedVersionapplication/pdfapplication/pdfhttp://hdl.handle.net/10230/57954http://dx.doi.org/10.1177/17588359221148921reponame:Recercat. Dipósit de la Recerca de Catalunyainstname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya)InglésTher Adv Med Oncol. 2023 Jan 19;15:17588359221148921© 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).http://creativecommons.org/licenses/by-nc/4.0/info:eu-repo/semantics/openAccessoai:recercat.cat:10230/579542026-05-29T05:05:01Z |
| 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 CDK4/6 inhibitor Advanced breast cancer 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, María Teresa Ramos, Manuel Cruz-Merino, Luis Santaballa, Ana O'Connor, Miriam Martínez-Jáñez, Noelia Moreno, Fernando Fernández, Isaura Virizuela, Juan Antonio Alarcón, Jesús Haba-Rodríguez, Juan de la Sánchez-Rovira, Pedro Albacar, Cinta Rosa Bueno Muiño, Carolia Kelly, Catherine Casas Sanahuja, Maribel Bezares, Susana Rosell, Libertad Albanell Mestres, Joan |
| author |
Tibau, Ariadna |
| author_facet |
Tibau, Ariadna Martínez, María Teresa Ramos, Manuel Cruz-Merino, Luis Santaballa, Ana O'Connor, Miriam Martínez-Jáñez, Noelia Moreno, Fernando Fernández, Isaura Virizuela, Juan Antonio Alarcón, Jesús Haba-Rodríguez, Juan de la Sánchez-Rovira, Pedro Albacar, Cinta Rosa Bueno Muiño, Carolia Kelly, Catherine Casas Sanahuja, Maribel Bezares, Susana Rosell, Libertad Albanell Mestres, Joan |
| author_role |
author |
| author2 |
Martínez, María Teresa Ramos, Manuel Cruz-Merino, Luis Santaballa, Ana O'Connor, Miriam Martínez-Jáñez, Noelia Moreno, Fernando Fernández, Isaura Virizuela, Juan Antonio Alarcón, Jesús Haba-Rodríguez, Juan de la Sánchez-Rovira, Pedro Albacar, Cinta Rosa Bueno Muiño, Carolia Kelly, Catherine Casas Sanahuja, Maribel Bezares, Susana Rosell, Libertad Albanell Mestres, Joan |
| author2_role |
author author author author author author author author author author author author author author author author author author author |
| dc.subject.none.fl_str_mv |
CDK4/6 inhibitor Advanced breast cancer Fulvestrant Palbociclib Patient-reported outcomes Quality of life |
| topic |
CDK4/6 inhibitor Advanced breast cancer 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 ⩾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. |
| publishDate |
2023 |
| dc.date.none.fl_str_mv |
2023 2023 2023 |
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info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion |
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article |
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publishedVersion |
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http://hdl.handle.net/10230/57954 http://dx.doi.org/10.1177/17588359221148921 |
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http://hdl.handle.net/10230/57954 http://dx.doi.org/10.1177/17588359221148921 |
| dc.language.none.fl_str_mv |
Inglés |
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Inglés |
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Ther Adv Med Oncol. 2023 Jan 19;15:17588359221148921 |
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http://creativecommons.org/licenses/by-nc/4.0/ info:eu-repo/semantics/openAccess |
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http://creativecommons.org/licenses/by-nc/4.0/ |
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openAccess |
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application/pdf application/pdf |
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SAGE Publications |
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SAGE Publications |
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reponame:Recercat. Dipósit de la Recerca de Catalunya instname:Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
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Varias* (Consorci de Biblioteques Universitáries de Catalunya, Centre de Serveis Científics i Acadèmics de Catalunya) |
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Recercat. Dipósit de la Recerca de Catalunya |
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