Article (Scientific journals)
Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study.
Fasching, Peter A.; Beck, J. Thaddeus; Chan, Arlene et al.
2020In Breast (Edinburgh, Scotland), 54, p. 148-154
Peer reviewed


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Keywords :
Breast cancer; Metastatic; Patient-reported outcomes; Quality of life; oncology
Abstract :
[en] 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.
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Author, co-author :
Fasching, Peter A.
Beck, J. Thaddeus
Chan, Arlene
De Laurentiis, Michele
Esteva, Francisco J.
Jerusalem, Guy  ;  Université de Liège - ULiège > Département des sciences cliniques > Oncologie
Neven, Patrick
Pivot, Xavier
Bianchi, Giulia V.
Martin, Miguel
Chandiwana, David
Lanoue, Brad
Ridolfi, Antonia
Wang, Yingbo
Rodriguez Lorenc, Karen
Nusch, Arnd
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Title :
Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study.
Publication date :
Journal title :
Breast (Edinburgh, Scotland)
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Peer reviewed :
Peer reviewed
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Copyright © 2020 The Authors. Published by Elsevier Ltd.. All rights reserved.
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since 10 November 2020


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