In the FLIPPER trial, FUL/PAL significantly improved progression-free survival (PFS) compared to FUL/PBO as first-line in patients (pts) with HR+/HER2- endocrine sensitive ABC. Here we present patient-reported outcome (PRO) results including health-related QoL (HRQoL).
Pts were randomized (1:1); 94 FUL/PAL, 95 FUL/PBO. PROs were evaluated at baseline (BL), every three cycles and at end of treatment using the EORTC QLQ-C30 and QLQ-BR23 questionnaires; 178 pts (94.2%) completed BL and ≥1 post-BL PROs. For functional and global health status (GHS)/QoL scales, higher scores represent better level of functioning or QoL and for symptom scales, worse symptoms. Time to deterioration (TTD) in GHS/QoL score considered ≥ 10points. Changes from BL and TTD were analysed using linear mixed-effect and Cox regression models, respectively.
Questionnaire completion rates were high (>95%) for the first 22 cycles. BL scores were comparable between the two treatment arms. Significant between-arm differences were observed in overall change from BL of GHS/QoL, appetite loss, constipation and systemic therapy side effect scores favouring FUL/PBO. No other statistically significant differences were found between arms for the remaining functional and symptom scales. Median TTD in GHS/QoL was delayed in FUL/PBOL [30.3 months (mo)] vs. FUL/PAL (11.1 mo) [adjusted HR (aHR) 1.57, 95% CI 1.03-2.39, p=0.036]; TTD in GHS/QoL was delayed in PBO-treated pts without progressive disease (PD) (aHR 2.0, 95% CI 1.1-3.8, p=0.023) but not in pts with PD (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.
The TTD in GHS/QoL was prolonged with FUL/PBO, however, GHS/QoL was improved numerically in both arms. The overall HRQoL differences favouring FUL/PBO were clinically meaningful only for appetite loss. These results together with the improvement of PFS observed with FUL/PAL make of this a beneficial therapeutic option for these patients.
NCT02690480.
GEICAM Breast Cancer Group.
GEICAM Spanish Breast Cancer Group.
A. Tibau: Honoraria (institution): Roche. M. Ramos: Speaker Bureau/Expert testimony: Pfizer; Speaker Bureau/Expert testimony: Novartis; Honoraria (institution): Roche. L. de la Cruz-Merino: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): MSD-Merck; Advisory/Consultancy, Research grant/Funding (institution): Roche; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): Bristol-Myers-Squibb; Advisory/Consultancy: Pierre Fabre; Advisory/Consultancy: Celgene. A. Santaballa: Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): GSK; Advisory/Consultancy, Speaker Bureau/Expert testimony: Clovis; Advisory/Consultancy, Speaker Bureau/Expert testimony, Research grant/Funding (institution): MSD; Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Advisory/Consultancy, Speaker Bureau/Expert testimony: Roche; Advisory/Consultancy, Research grant/Funding (institution): Pfizer. N. Martinez-Jañez: Advisory/Consultancy: Roche; Advisory/Consultancy: AstraZeneca; Advisory/Consultancy: Daiichi; Advisory/Consultancy: Pfizer; Advisory/Consultancy: Novartis; Advisory/Consultancy: Lilly; Advisory/Consultancy: Eisai. F. Moreno: Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Travel/Accommodation/Expenses: Novartis; Advisory/Consultancy: MSD; Advisory/Consultancy: AstraZeneca. I. Fernandez-Perez: Advisory/Consultancy, Research grant/Funding (institution): Roche; Honoraria (institution), Advisory/Consultancy, Research grant/Funding (institution): AstraZeneca; Honoraria (institution): Pfizer; Honoraria (institution): Novartis; Honoraria (institution): Clovis. J. Alarcón: Honoraria (institution), Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: GSK; Honoraria (institution), Speaker Bureau/Expert testimony: Clovis; Honoraria (institution), Speaker Bureau/Expert testimony: Roche; Honoraria (institution), Advisory/Consultancy, Speaker Bureau/Expert testimony: AstraZeneca; Honoraria (institution), Advisory/Consultancy: MSD. J. de la Haba-Rodríguez: Honoraria (institution): AstraZeneca; Honoraria (institution): Pfizer; Honoraria (institution): Novartis; Honoraria (institution): Lilly. C. Bueno: Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Roche; Speaker Bureau/Expert testimony, Travel/Accommodation/Expenses: Novartis; Speaker Bureau/Expert testimony: MSD; Speaker Bureau/Expert testimony: AstraZeneca; Travel/Accommodation/Expenses: Pfizer. J. Albanell: Advisory/Consultancy: Genomic Health; Advisory/Consultancy, Travel/Accommodation/Expenses: Roche; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Pfizer; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Amgen; Advisory/Consultancy, Research grant/Funding (institution): MSD; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Lilly; Advisory/Consultancy, Research grant/Funding (institution), Travel/Accommodation/Expenses: Daiichi Sankyo. All other authors have declared no conflicts of interest.