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

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

Interactive visualization of Health-Related Quality of Life (HRQOL) outcomes from the MONALEESA-3 study.

CITATION Fasching et al. The Breast 54 (2020) 148-154
DOI 10.1016/j.breast.2020.09.008
YEAR 2020
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Study Design & Arms

Advanced Breast CancerHR+/HER2- PostmenopausalRibociclib plus fulvestrantn = 484Placebo plus fulvestrantn = 242Primary EndpointsPFS, OSSecondary (PROs)EORTC QLQ-C30, BPI-SF
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Baseline Scores (Mean ± SD)

Comparison of baseline QOL and Pain scores between arms.

Baseline Global Health Status/QOL Score (EORTC QLQ-C30)Baseline Pain Score (EORTC QLQ-C30)020406080100Ribociclib plus fulvestrantPlacebo plus fulvestrant
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Hazard Ratios: Time to Deterioration (TTD)

Forest plot of Hazard Ratios (HR < 1 favors Ribociclib). Error bars = 95% CI.

0.40.60.81.01.2Global Health StatusBPI-SF Pain Severity IndexPhysical FunctioningEmotional Functioning0.81 [0.62-1.1]0.77 [0.57-1.05]0.82 [0.61-1.1]0.76 [0.57-1.01]
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Risk Reduction (1 - HR)

Percentage reduction in risk of deterioration (Ribociclib vs Placebo).

Global Health StatusBPI-SF Pain Severity IndexPhysical FunctioningEmotional Functioning0%5%10%15%20%25%30%
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Sample Size Distribution

N=726Ribociclib plus fulvestrant (n=484)Placebo plus fulvestrant (n=242)
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Metric Summary Scorecard

Baseline Global Health Status/QOL Sco...G1: 65.5 vs G2: 68.4Baseline Pain Score (EORTC QLQ-C30)G1: 30 vs G2: 27.8Hazard Ratio for Time to Definitive D...HR: 0.81 [95% CI, 0.62–1.1]Hazard Ratio for Time to Definitive D...HR: 0.77 [95% CI, 0.57–1.05]Hazard Ratio for Time to Definitive D...HR: 0.82 [95% CI, 0.61–1.10]Hazard Ratio for Time to Definitive D...HR: 0.76 [95% CI, 0.57–1.01]
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Appendix: Raw Data & Provenance

Metric ID Metric Name Value Provenance
M01 Baseline Global Health Status/QOL Score (EORTC QLQ-C30) (Ribociclib plus fulvestrant) 65.5 (19.1) Table 1 (p.2)
M01 Baseline Global Health Status/QOL Score (EORTC QLQ-C30) (Placebo plus fulvestrant) 68.4 (18.5) Table 1 (p.2)
M02 Baseline Pain Score (EORTC QLQ-C30) (Ribociclib plus fulvestrant) 30.0 (25.5) Table 1 (p.2)
M02 Baseline Pain Score (EORTC QLQ-C30) (Placebo plus fulvestrant) 27.8 (25.9) Table 1 (p.2)
M03 Hazard Ratio for Time to Definitive Deterioration ≥10% (Global Health Status) (Ribociclib plus fulvestrant) 0.81 [95% CI, 0.62–1.1] Abstract (p.1)
M04 Hazard Ratio for Time to Definitive Deterioration ≥10% (BPI-SF Pain Severity Index) (Ribociclib plus fulvestrant) 0.77 [95% CI, 0.57–1.05] Abstract (p.1)
M05 Hazard Ratio for Time to Definitive Deterioration ≥10% (Physical Functioning) (Ribociclib plus fulvestrant) 0.82 [95% CI, 0.61–1.10] Results Section 3.3 (p.3)
M06 Hazard Ratio for Time to Definitive Deterioration ≥10% (Emotional Functioning) (Ribociclib plus fulvestrant) 0.76 [95% CI, 0.57–1.01] Results Section 3.3 (p.3)
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