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 evidence dashboard for MONALEESA-3 Quality of Life outcomes.

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

Randomization2:1 RatioRibociclib plus fulvestrantn = 484Ribociclib (600 mg/day; 3 weeks on/1 week off) + fulvestrant (500 mg)Placebo plus fulvestrantn = 242Placebo + fulvestrant (500 mg)
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Hazard Ratios: Time to Deterioration

Lower HR favors Ribociclib

Comparison of Time to Definitive Deterioration (TTD) across functional and symptom scales. Error bars represent 95% Confidence Intervals.

0.40.60.81.01.21.4Time to definitive deterioration (TTD) ≥10% in Global Health StatusPhysical FunctioningEmotional FunctioningBPI-SF Pain Severity IndexFavors RibociclibFavors Placebo0.81 [95% CI, 0.62–1.1]0.82 [95% CI, 0.61–1.10]0.76 [95% CI, 0.57–1.01]0.77 [95% CI, 0.57–1.05]
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Baseline Scores Comparison

Mean baseline scores (±SD) for Global Health Status and Pain. Scores are 0-100 scale.

Baseline Global Health Status ScoreBaseline Pain Score (EORTC QLQ-C30)020406080100Score (0-100)Ribociclib + FulvPlacebo + Fulv
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Global Health Status: Detailed HR View

0.60.811.2No Difference0.8195% CI: 0.62 – 1.1Time to definitive deterioration (TTD) ≥10% in Global Health Status (Hazard Ratio)
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Pain Analysis: Baseline vs Deterioration

Baseline Pain Score (Lower is Better)Ribociclib plus fulvestrantPlacebo plus fulvestrant0204060801003027.8Time to Deterioration (HR)0.00.20.40.60.81.01.21.40.77 [95% CI, 0.57–1.05]Favors Ribociclib
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Metric Summary Heatmap

Time to definitive deterioration (TTD) ≥10% in Global Health Status (Hazard Ratio)Trend Benefit0.81 [95% CI, 0.62–1.1]TTD ≥10% in Physical Functioning (Hazard Ratio)Trend Benefit0.82 [95% CI, 0.61–1.10]TTD ≥10% in Emotional Functioning (Hazard Ratio)Trend Benefit0.76 [95% CI, 0.57–1.01]TTD ≥10% in BPI-SF Pain Severity Index (Hazard Ratio)Trend Benefit0.77 [95% CI, 0.57–1.05]Baseline Global Health Status ScoreNeutral65.5 (19.1)Baseline Pain Score (EORTC QLQ-C30)Neutral30.0 (25.5)
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Appendix: Raw Data & Provenance

ID Metric Value Provenance
M01 Time to definitive deterioration (TTD) ≥10% in Global Health Status (Hazard Ratio) (Ribociclib plus fulvestrant) 0.81 [95% CI, 0.62–1.1] [Abstract / Results, p1] "HR for TTD ≥10% = 0.81 [95% CI, 0.62–1.1]... TTD ≥10% in emotional functioning (HR = 0.76 [95% CI, 0.57–1.01])"
M02 TTD ≥10% in Physical Functioning (Hazard Ratio) (Ribociclib plus fulvestrant) 0.82 [95% CI, 0.61–1.10] [Abstract / Results, p1] "HR for TTD ≥10% = 0.81 [95% CI, 0.62–1.1]... TTD ≥10% in emotional functioning (HR = 0.76 [95% CI, 0.57–1.01])"
M03 TTD ≥10% in Emotional Functioning (Hazard Ratio) (Ribociclib plus fulvestrant) 0.76 [95% CI, 0.57–1.01] [Abstract / Results, p1] "HR for TTD ≥10% = 0.81 [95% CI, 0.62–1.1]... TTD ≥10% in emotional functioning (HR = 0.76 [95% CI, 0.57–1.01])"
M04 TTD ≥10% in BPI-SF Pain Severity Index (Hazard Ratio) (Ribociclib plus fulvestrant) 0.77 [95% CI, 0.57–1.05] [Abstract / Results, p1] "HR for TTD ≥10% = 0.81 [95% CI, 0.62–1.1]... TTD ≥10% in emotional functioning (HR = 0.76 [95% CI, 0.57–1.01])"
M05 Baseline Global Health Status Score (Ribociclib plus fulvestrant) 65.5 (19.1) [Table 1, p2] "Global HRQOL... Ribociclib + fulvestrant Baseline (n=447) 65.5 (19.1)... Placebo + fulvestrant Baseline (n=224) 68.4 (18.5)"
M05 Baseline Global Health Status Score (Placebo plus fulvestrant) 68.4 (18.5) [Table 1, p2] "Global HRQOL... Ribociclib + fulvestrant Baseline (n=447) 65.5 (19.1)... Placebo + fulvestrant Baseline (n=224) 68.4 (18.5)"
M06 Baseline Pain Score (EORTC QLQ-C30) (Ribociclib plus fulvestrant) 30.0 (25.5) [Table 1, p2] "Global HRQOL... Ribociclib + fulvestrant Baseline (n=447) 65.5 (19.1)... Placebo + fulvestrant Baseline (n=224) 68.4 (18.5)"
M06 Baseline Pain Score (EORTC QLQ-C30) (Placebo plus fulvestrant) 27.8 (25.9) [Table 1, p2] "Global HRQOL... Ribociclib + fulvestrant Baseline (n=447) 65.5 (19.1)... Placebo + fulvestrant Baseline (n=224) 68.4 (18.5)"
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