Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study
Fasching P, Beck JT, Chan A, De Laurentiis M, Esteva FJ, Jerusalem G, Neven P, Pivot X, Bianchi GV, Martin M, Chandiwana D, Lanoue B, Ridolfi A, Wang Y, Rodriguez Lorenc K, Nusch A (2020)
Publication Type: Journal article
Publication year: 2020
Journal
Book Volume: 54
Pages Range: 148-154
DOI: 10.1016/j.breast.2020.09.008
Abstract
Purpose: In the MONALEESA-3 Phase III trial of patients with hormone receptor–positive human epidermal growth factor receptor–negative advanced breast cancer, ribociclib plus fulvestrant significantly improved progression-free survival (PFS) and overall survival (OS). Here, we present patient-reported outcomes from the trial, including health-related quality of life (HRQOL). Methods: Patients were randomized (2:1) to receive ribociclib plus fulvestrant or placebo plus fulvestrant. Time to definitive 10% deterioration (TTD) from baseline in HRQOL (global health status [GHS] from the EORTC QLQ-C30 questionnaire) and pain (BPI-SF questionnaire) were assessed using Kaplan-Meier estimates; a stratified Cox regression model was used to estimate the hazard ratio (HR) and 95% CIs. Results: Deterioration ≥10% in the EORTC-QLQ-C30 GHS was observed in 33% of patients in the ribociclib group vs 34% of patients in the placebo (reference) group (HR for TTD ≥ 10% = 0.81 [95% CI, 0.62–1.1]). Similar findings were noted for TTD ≥5% (HR = 0.79 [95% CI, 0.61–1.0]) and TTD ≥15% (HR = 0.81 [95% CI, 0.60–1.08]). TTD ≥10% in emotional functioning (HR = 0.76 [95% CI, 0.57–1.01]) trended in favor of the ribociclib group, whereas results for fatigue and pain were similar between arms. TTD ≥10% in BPI-SF pain severity index score (HR = 0.77 [95% CI, 0.57–1.05]) and worst pain item score (HR = 0.81 [95% CI, 0.58–1.12]) trended in favor of ribociclib vs placebo. Conclusions: In addition to significantly prolonging PFS and OS compared with placebo plus fulvestrant, adding ribociclib to fulvestrant maintains HRQOL.
Authors with CRIS profile
Involved external institutions
Highlands Oncology Group
United States (USA) (US)
Universidad Complutense de Madrid (UCM)
Spain (ES)
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Italy (IT)
New York University (NYU)
United States (USA) (US)
Novartis AG
Switzerland (CH)
Centre Paul Strauss (UNICANCER)
France (FR)
Novartis Pharma S.A.S.
France (FR)
University Hospital Leuven (UZ) / Universitaire ziekenhuizen Leuven
Belgium (BE)
Breast Cancer Research Centre-Western Australia
Australia (AU)
Centre Hospitalier Universitaire de Liège (CHU Liège)
Belgium (BE)
Fondazione IRCCS: Istituto Nazionale dei Tumori
Italy (IT)
United States (USA) (US)
Universidad Complutense de Madrid (UCM)
Spain (ES)
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale"
Italy (IT)
New York University (NYU)
United States (USA) (US)
Novartis AG
Switzerland (CH)
Centre Paul Strauss (UNICANCER)
France (FR)
Novartis Pharma S.A.S.
France (FR)
University Hospital Leuven (UZ) / Universitaire ziekenhuizen Leuven
Belgium (BE)
Breast Cancer Research Centre-Western Australia
Australia (AU)
Centre Hospitalier Universitaire de Liège (CHU Liège)
Belgium (BE)
Fondazione IRCCS: Istituto Nazionale dei Tumori
Italy (IT)
How to cite
APA:
Fasching, P., Beck, J.T., Chan, A., De Laurentiis, M., Esteva, F.J., Jerusalem, G.,... Nusch, A. (2020). Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study. BREAST , 54, 148-154. https://doi.org/10.1016/j.breast.2020.09.008
MLA:
Fasching, Peter, et al. "Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study." BREAST 54 (2020): 148-154.
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