Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study

Peter A. Fasching, J. Thaddeus Beck, Arlene Chan, Michele De Laurentiis, Francisco J. Esteva, Guy Jerusalem, Patrick Neven, Xavier Pivot, Giulia V. Bianchi, Miguel Martin, David Chandiwana, Brad Lanoue, Antonia Ridolfi, Yingbo Wang, Karen Rodriguez Lorenc, Arnd Nusch

Research output: Contribution to journalArticlepeer-review

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 10TTD) 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 Deterioration ≥10QLQ-C30 GHS was observed in 334reference) group (HR for TTD ≥ 10= 0.81 [95 0.62-1.1]). Similar findings were noted for TTD ≥5HR = 0.79 [95 0.61-1.0]) and TTD ≥15HR = 0.81 [95 0.60-1.08]). TTD ≥10HR = 0.76 [95 0.57-1.01]) trended in favor of the ribociclib group, whereas results for fatigue and pain were similar between arms. TTD ≥10SF pain severity index score (HR = 0.77 [95 0.57-1.05]) and worst pain item score (HR = 0.81 [95 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.
Original languageEnglish
JournalBreast
Publication statusPublished - Dec 1 2020

Fingerprint

Dive into the research topics of 'Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study'. Together they form a unique fingerprint.

Cite this