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...
| Autores: | , , , , , , |
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| Tipo de recurso: | artículo |
| Estado: | Versión publicada |
| Fecha de publicación: | 2023 |
| País: | España |
| Institución: | Universidad de Sevilla (US) |
| Repositorio: | idUS. Depósito de Investigación de la Universidad de Sevilla |
| OAI Identifier: | oai:idus.us.es:11441/155769 |
| Acceso en línea: | https://hdl.handle.net/11441/155769 https://doi.org/0.1177/17588359221148921 |
| Access Level: | acceso abierto |
| Palabra clave: | Advanced breast cancer CDK4/6 inhibitor Fulvestrant Palbociclib Patient reported outcomes Quality of life |
| Sumario: | 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. |
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