Abstract 4241
Background
In the Phase III MONALEESA-7 trial (NCT02278120), RIB + TAM/NSAI + goserelin (GOS) significantly improved progression-free survival vs placebo (PBO) + TAM/NSAI + GOS in premenopausal pts with HR+, HER2– ABC; here we report key PRO data.
Methods
Pre/perimenopausal pts (N = 672; ≤1 line of prior chemotherapy and no prior endocrine therapy for ABC) were randomized 1:1 to RIB (600 mg/day; 3 weeks on/1 week off) or PBO + TAM (20 mg/day) or an NSAI (letrozole [2.5 mg/day]/anastrozole [1 mg/day]) + GOS (3.6 mg every 28 days). Primary endpoint: PFS. PROs were a secondary endpoint and were evaluated using EORTC QLQ-C30, QLQ-BR23, EQ-5D-5L, and WPAI-GH questionnaires. Changes from baseline and time to 10% deterioration (TTD) in health-related quality of life (HRQoL) were analyzed using linear mixed-effect and stratified Cox regression models, respectively.
Results
Questionnaire compliance was high (>75%). On-treatment HRQoL (EORTC QLQ-C30 global health status/QoL score) was maintained up to Cycle (C) 17 in both arms. From C18 onwards, HRQoL improved in the RIB arm (clinically meaningful improvements [>5 points] at C5 and from C19 to C31), but numerically worsened in the PBO arm. Median TTD in HRQoL was not reached (NR) in the RIB arm (95% CI 22.2–NR) vs 21.2 months in the PBO arm (95% CI 15.4–23.0; hazard ratio 0.699; 95% CI 0.533–0.916; p = 0.004). EORTC QLQ-C30 physical, social, and role functioning domains, and WPAI-GH % work time missed were maintained in the RIB arm; physical and role functioning were maintained for a longer duration in the RIB vs PBO arm. WPAI-GH % activity impairment was maintained in the RIB vs PBO arm. Reductions in EORTC QLQ-C30 pain score were observed up to C28 in the RIB arm and up to C17 in the PBO arm; clinically meaningful reductions were observed in the RIB arm from C3 to C11 and C22 to C28.
Conclusions
RIB + TAM/NSAI + GOS improves HRQoL and maintains functioning, work productivity, and activity in premenopausal pts with HR+, HER2– ABC. RIB + TAM/NSAI + GOS is also associated with a clinically meaningful reduction in pain vs PBO + TAM/NSAI + GOS.
Clinical trial identification
NCT02278120, 29 October 2014.
Legal entity responsible for the study
Novartis Pharmaceuticals Corporation.
Funding
Novartis Pharmaceuticals Corporation.
Editorial Acknowledgement
Bhavika Modasia PhD of ArticulateScience Ltd.
Disclosure
N. Harbeck: Personal fees for lectures/consulting: Eli-Lilly, Novartis, Pfizer, during the conduct of the study. P. Wheatley-Price: Personal fees for advisory boards: Novartis, AstraZeneca, Lilly Oncology, Bristol-Myers Squibb, Merck, Takeda, during the conduct of the study. B. Lanoue: Employed by Novartis Pharmaceuticals Corporation, during the conduct of the study. J. Alam: Employment: Novartis. D. Chandiwana: Employment and stock ownership: Novartis. M. Colleoni: Fees for advisory boards: AstraZeneca, Pierre Fabre, Pfizer, OBI Pharma, Puma Biotechnology, and Celldex; Honoraria: Novartis, outside the submitted work. All other authors have declared no conflicts of interest.