Abstract 4295
Background
In the MONALEESA-3 trial (NCT02422615), ribociclib + fulvestrant significantly improved progression-free survival (PFS) vs placebo + fulvestrant in patients with hormone receptor-positive, human epidermal growth factor receptor 2-negative BC who had received no or only 1 line of prior endocrine therapy for ABC. Here, we present PROs from the trial, including health-related quality of life (HRQoL).
Methods
Patients were randomized (2:1) to receive ribociclib (600 mg/day, 3-weeks-on/1-week-off) + fulvestrant (500 mg on Day 1 of every cycle and Cycle 1 Day 15; n = 484) or placebo + fulvestrant (n = 242). Time to definitive 10% deterioration from baseline (TTD) in HRQoL (global health status/quality of life scale score of the EORTC QLQ-C30 questionnaire [GHS/QLS]) and pain (BPI-SF questionnaire) were compared between treatment arms using a stratified log-rank test; a stratified Cox regression was used to estimate the hazard ratio with 95% confidence intervals (CI). PROs were also assessed using the EQ-5D-5L questionnaire.
Results
Questionnaire compliance rates were high (>90% at baseline for each measure). Mean GHS/QLS was maintained or improved during every cycle of treatment in both arms (mean change from baseline up to Cycle 19 [n ≥ 50 in both arms]: ribociclib + fulvestrant 3.6–4.9; placebo + fulvestrant 1.3–4.3). At the end of treatment, addition of ribociclib to fulvestrant had not negatively impacted GHS/QLS (mean change from baseline: –5.2 points in the ribociclib arm [n = 184] vs –5.5 points in the placebo arm [n = 113]). Median TTD in GHS/QLS was not reached (NR) in the ribociclib arm (95% CI 22.1–NR) vs 19.4 months in the placebo arm (95% CI 16.6–NR); hazard ratio: 0.80 (95% CI 0.60–1.05). Using the BPI-SF scale, median TTD was 25.4 months in the ribociclib arm vs NR in the placebo arm for worst pain (hazard ratio: 0.81; 95% CI 0.58–1.13), 25.4 months vs NR for pain severity index (hazard ratio: 0.81; 95% CI 0.60–1.11), and NR vs NR for pain interference index (hazard ratio: 0.87, 95% CI 0.63–1.21).
Conclusions
As well as significantly prolonging PFS compared with placebo + fulvestrant, adding ribociclib to fulvestrant maintains quality of life.
Clinical trial identification
NCT02422615, April 21, 2015.
Legal entity responsible for the study
Novartis Pharmaceuticals Corporation.
Funding
Novartis Pharmaceuticals Corporation.
Editorial Acknowledgement
John Munro of ArticulateScience Ltd.
Disclosure
P.A. Fasching: Grants and personal fees: Novartis; Personal fees: Roche, Pfizer, Celgene and Teva, during the conduct of the study. F.J. Esteva: Grants and personal fees; Novartis during the conduct of the study. A. Pieris-Gunatilaka, B. Lanoue: Employment: Novartis. Y. Wang, D. Chandiwana: Employment and stock ownership: Novartis. All other authors have declared no conflicts of interest.