dc.creator | Tibau, Ariadna | es |
dc.creator | Martínez, M. Teresa | es |
dc.creator | Ramos, Manuel | es |
dc.creator | Cruz Merino, Luis de la | es |
dc.creator | Santaballa, Ana | es |
dc.creator | O’Connor, Miriam | es |
dc.creator | Albanell, Joan | es |
dc.date.accessioned | 2024-03-01T18:44:35Z | |
dc.date.available | 2024-03-01T18:44:35Z | |
dc.date.issued | 2023 | |
dc.identifier.citation | Tibau, A., Martínez, M.T., Ramos, M., Cruz Merino, L.d.l., Santaballa, A., O’Connor, M. y Albanell, J. (2023). 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. herapeutic Advances in Medical Oncology, 15, 17588359221148921. https://doi.org/0.1177/17588359221148921. | |
dc.identifier.issn | 1758-8340 | es |
dc.identifier.issn | 1758-8359 | es |
dc.identifier.uri | https://hdl.handle.net/11441/155769 | |
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 ⩾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. | es |
dc.format | application/pdf | es |
dc.format.extent | 14 p. | es |
dc.language.iso | eng | es |
dc.publisher | Sage Journals | es |
dc.relation.ispartof | herapeutic Advances in Medical Oncology, 15, 17588359221148921. | |
dc.rights | Attribution-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nd/4.0/ | * |
dc.subject | Advanced breast cancer | es |
dc.subject | CDK4/6 inhibitor | es |
dc.subject | Fulvestrant | es |
dc.subject | Palbociclib | es |
dc.subject | Patient reported outcomes | es |
dc.subject | Quality of life | es |
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 | es |
dc.type | info:eu-repo/semantics/article | es |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.relation.publisherversion | https://journals.sagepub.com/doi/10.1177/17588359221148921 | es |
dc.identifier.doi | 0.1177/17588359221148921 | es |
dc.contributor.group | Universidad de Sevilla. CTS151: Bioquímica médica. | es |
dc.journaltitle | herapeutic Advances in Medical Oncology | es |
dc.publication.volumen | 15 | es |
dc.publication.initialPage | 17588359221148921 | es |