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.
|Publication status||Published - Dec 1 2020|