Theme
MONALEESA-3: QoL Analysis
Source
Source: Fasching PA, et al. Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study. The Breast. 2020;54:148-154.
Ribociclib + Fulvestrant delays deterioration while improving survival in HR+/HER2- Advanced Breast Cancer.
Population & Design
N = 726
Postmenopausal Women
Phase III, Randomized (2:1), Double-blind
Treatment Arms
- Ribociclib + Fulv (n=484)
- Placebo + Fulv (n=242)
Global Health Status
0.81
Hazard Ratio
Trend favoring Ribociclib for Time to Deterioration
Key QoL Outcomes
Emotional Functioning
HR: 0.76
Maintained longer with combination therapy.
Pain Progression
HR: 0.77
Significant delay in pain deterioration.
Note: Fatigue and physical scores remained comparable between arms.
Time to 10% Deterioration
Clinical Recommendation
Clinicians should confidently incorporate Ribociclib into regimens. Data confirms survival benefits without detriment to Quality of Life (HRQOL), validating it as a standard-of-care combination.
AbbreviationsQuick
BPI-SF, Brief Pain Inventory-Short Form; CI, confidence interval; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer Core Quality of Life Questionnaire; EOT, end of treatment; FUL, fulvestrant; GHS, global health status; HER2-, human epidermal growth factor receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; HRQOL, health-related quality of life; LSM, least squares mean; OS, overall survival; PBO, placebo; PFS, progression-free survival; PRO, patient-reported outcome; QOL, quality of life; RIB, ribociclib; SD, standard deviation; SEM, standard error of the mean; TTD, time to definitive deterioration.
Bibliography1
- Fasching PA, Beck JT, Chan A, et al. Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study. The Breast. 2020;54:148-154. (DOI: 10.1016/j.breast.2020.09.008 | link)
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