Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study
Fasching et al. The Breast 54 (2020) 148-154 (2020) • DOI: 10.1016/j.breast.2020.09.008
Key Finding: Ribociclib + Fulvestrant maintains Health-Related Quality of Life (HRQoL) while delaying deterioration compared to Placebo.
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Study Design & Arms
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Baseline Scores (Mean ± SD)
Comparing baseline Global Health Status and Pain scores between arms. Higher Global Health is better; Lower Pain is better.
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Time to Deterioration (Hazard Ratios)
Hazard Ratio (HR) < 1.0 indicates Ribociclib delays deterioration compared to Placebo.
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Median Time to Deterioration (Months)
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Pain Reduction at 8 Weeks
Change from baseline in EORTC QLQ-C30 pain scores. Negative values indicate improvement (reduction in pain).
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Primary QoL Outcome: Global Health Status
Metric: Time to definitive deterioration (TTD) ≥10% in Global Health Status
Result: Hazard Ratio 0.81 (Favors Ribociclib)
Interpretation: Patients on Ribociclib + Fulvestrant maintained their global health status longer than those on Placebo (Median 35.9 vs 33.1 months).
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Appendix: Raw Data & Provenance
| Metric | Group | Value | Source |
|---|---|---|---|
| Baseline Global Health Status/QOL Score | Ribociclib plus fulvestrant | 65.5 (19.1) | Table 1 (p2) |
| Baseline Global Health Status/QOL Score | Placebo plus fulvestrant | 68.4 (18.5) | Table 1 (p2) |
| Baseline Pain Score (EORTC QLQ-C30) | Ribociclib plus fulvestrant | 30.0 (25.5) | Table 1 (p2) |
| Baseline Pain Score (EORTC QLQ-C30) | Placebo plus fulvestrant | 27.8 (25.9) | Table 1 (p2) |
| Time to definitive deterioration (TTD) ≥10% in Global Health Status | Ribociclib plus fulvestrant | 35.9 (HR 0.81) | Figure 2a (p4) |
| Time to definitive deterioration (TTD) ≥10% in Global Health Status | Placebo plus fulvestrant | 33.1 | Figure 2a (p4) |
| Time to definitive deterioration (TTD) ≥10% in Physical Functioning | Ribociclib plus fulvestrant | 38.7 (HR 0.82) | Results Section 3.3 (p3) |
| Time to definitive deterioration (TTD) ≥10% in Physical Functioning | Placebo plus fulvestrant | 34.9 | Results Section 3.3 (p3) |
| Time to definitive deterioration (TTD) ≥10% in Emotional Functioning | Ribociclib plus fulvestrant | 38.6 (HR 0.76) | Results Section 3.3 (p3) |
| Time to definitive deterioration (TTD) ≥10% in Emotional Functioning | Placebo plus fulvestrant | 30.4 | Results Section 3.3 (p3) |
| Time to definitive deterioration (TTD) ≥10% in Fatigue | Ribociclib plus fulvestrant | 38.7 (HR 0.91) | Results Section 3.3 / 3.4 (p5) |
| Time to definitive deterioration (TTD) ≥10% in Fatigue | Placebo plus fulvestrant | 36.0 | Results Section 3.3 / 3.4 (p5) |
| Time to definitive deterioration (TTD) ≥10% in Pain (EORTC QLQ-C30) | Ribociclib plus fulvestrant | 41.9 (HR 1.06) | Results Section 3.3 / 3.4 (p5) |
| Time to definitive deterioration (TTD) ≥10% in Pain (EORTC QLQ-C30) | Placebo plus fulvestrant | not estimable | Results Section 3.3 / 3.4 (p5) |
| Time to definitive deterioration (TTD) ≥10% in BPI-SF Pain Severity Index | Ribociclib plus fulvestrant | 42.7 (HR 0.77) | Figure 5 (p6) |
| Time to definitive deterioration (TTD) ≥10% in BPI-SF Pain Severity Index | Placebo plus fulvestrant | 35.9 | Figure 5 (p6) |
| Change from baseline in EORTC QLQ-C30 pain scores at 8 weeks | Ribociclib plus fulvestrant | -4.0 | Results Section 3.3 / 3.4 (p5) |
| Change from baseline in EORTC QLQ-C30 pain scores at 8 weeks | Placebo plus fulvestrant | -3.6 | Results Section 3.3 / 3.4 (p5) |
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