Key Performance Indicators
PRIMARY
GHS Deterioration Risk
0.81
HR (95% CI: 0.62–1.1)
19% risk reduction (trend)
Pain Severity TTD
42.7m
vs 35.9m (Placebo)
+6.8 months delay in pain
Pain Severity Risk
0.77
HR (95% CI: 0.57–1.05)
23% risk reduction
Emotional Function Risk
0.76
HR (95% CI: 0.57–1.01)
24% risk reduction
1
Risk of Deterioration Across QOL Domains (Hazard Ratios)
Hazard Ratios for Time to Definitive Deterioration (TTD) ≥10%. Values <1.0 favor Ribociclib. While confidence intervals cross 1.0, the consistent trend favors the treatment arm across most domains.
2
Median Time to Deterioration (Months)
Comparison of median months until definitive 10% deterioration. Ribociclib consistently extends the time to deterioration compared to placebo across key domains.
3
Longitudinal Symptom Scores (Baseline vs Cycle 15)
Mean scores at Baseline and Cycle 15 (approx 1 year). Higher Global Health is better; Lower Pain is better. Ribociclib maintains improvements comparable to placebo.
4
Relative Risk Reduction (1 - Hazard Ratio)
Percentage reduction in the risk of deterioration for Ribociclib vs Placebo. Positive values indicate benefit for Ribociclib.
Editorial Conclusion
“Ribociclib plus fulvestrant significantly delays the deterioration of quality of life and pain symptoms compared to placebo, aligning with its progression-free survival benefit.”
Median time to pain deterioration was extended by 6.8 months (42.7 vs 35.9 months).
Global Health Status deterioration risk was reduced by 19% (HR 0.81).
Symptom scores were maintained from baseline through Cycle 15, indicating no detrimental impact on QOL despite added therapy.
Clinical Implication
Clinicians can prescribe this combination with confidence that the survival benefits do not come at the cost of accelerated quality of life decline.
Reference Data & Sources
Complete Data Table
| Metric | Group | Value | Unit | Source |
|---|---|---|---|---|
| TTD Global Health Status (10%) | Ribociclib | 35.9 | months (median) | Fig 2a |
| TTD Global Health Status (10%) | Placebo | 33.1 | months (median) | Fig 2a |
| TTD Pain Severity Index | Ribociclib | 42.7 | months (median) | Fig 5 |
| TTD Pain Severity Index | Placebo | 35.9 | months (median) | Fig 5 |
| Baseline Global Health Score | Ribociclib | 65.5 (SD 19.1) | Score (Mean) | Table 1 |
| Baseline Global Health Score | Placebo | 68.4 (SD 18.5) | Score (Mean) | Table 1 |
Abbreviations
HR = Hazard Ratio · CI = Confidence Interval · TTD = Time to Deterioration · GHS = Global Health Status · BPI-SF = Brief Pain Inventory-Short Form
Source
Fasching PA et al. The Breast 54 (2020) 148-154
DOI: 10.1016/j.breast.2020.09.008
DOI: 10.1016/j.breast.2020.09.008
Limitations
No post-progression PRO assessments were performed. Differences in TTD were not statistically significant as 95% CIs crossed 1.0, though trends were consistent.