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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

Fasching et al. The Breast 54 (2020) 148-154 | DOI: 10.1016/j.breast.2020.09.008
726
Total Patients
20.4 mo
Median Follow-up
QOL
Maintained in Both Arms
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Study Design & Arms

Randomized, double-blind, placebo-controlled trial (2:1 ratio).

Ribociclib + fulvestrantN=484 | Ribociclib (600 mg/day; 3 weeks on/1 week off) + fulvestrant (500 mg on day 1 of...Placebo + fulvestrantN=242 | Placebo + fulvestrant (500 mg on day 1 of each 28-day cycle)...Randomization 2:1
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Baseline Global Health Status (EORTC QLQ-C30)

Mean baseline scores were well balanced between arms (0-100 scale, higher is better).

Ribociclib + fulvestrantPlacebo + fulvestrant02040608010065.568.4
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Hazard Ratios: Time to Deterioration (TTD)

HR < 1 favors Ribociclib. Error bars represent 95% CI.

0.40.60.81.01.21.4Global Health StatusPain Severity Index (BPI-SF)Fatigue (EORTC QLQ-C30)HR 0.81 (0.62-1.06)HR 0.77 (0.57-1.05)HR 0.91 (0.68-1.22)← Favors RibociclibFavors Placebo →
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Median Time to Deterioration (Months)

Comparison of median months until 10% deterioration in scores.

Global Health StatusPain Severity IndexFatigue051015202530354045MonthsRibociclib + fulvestrantPlacebo + fulvestrant
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Change in Pain Scores (8 Weeks)

Change from baseline (Negative is better). Difference not statistically significant.

Ribociclib + fulvestrantPlacebo + fulvestrant−5.0−4.5−4.0−3.5−3.0−2.5−2.0−1.5−1.0−0.50.0-4-3.6
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Metric Summary

Overview of all extracted metrics and statistical comparisons.

MetricRibociclib ArmPlacebo ArmComparisonBaseline Global Health Status/QOL Score (EORTC ...65.5 (19.1)68.4 (18.5)Time to definitive 10% deterioration (TTD) in G...35.933.1HR 0.81 (0.62-1.06)Time to definitive 10% deterioration (TTD) in P...42.735.9HR 0.77 (0.57-1.05)Time to definitive 10% deterioration (TTD) in F...38.736.0HR 0.91 (0.68-1.22)Change from baseline in EORTC QLQ-C30 pain scor...-4.0-3.6Diff -0.3 (CI -4.0 to 3.3)
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Appendix: Raw Data & Provenance

Metric ID Metric Name Group Value Comparison Source
M01 Baseline Global Health Status/QOL Score (EORTC QLQ-C30) Ribociclib + fulvestrant 65.5 (19.1) - Table 1 (p.2)
M01 Baseline Global Health Status/QOL Score (EORTC QLQ-C30) Placebo + fulvestrant 68.4 (18.5) - Table 1 (p.2)
M02 Time to definitive 10% deterioration (TTD) in Global Health Status Ribociclib + fulvestrant 35.9 HR 0.81 (0.62-1.06) Figure 2a (p.4)
M02 Time to definitive 10% deterioration (TTD) in Global Health Status Placebo + fulvestrant 33.1 - Figure 2a (p.4)
M03 Time to definitive 10% deterioration (TTD) in Pain Severity Index (BPI-SF) Ribociclib + fulvestrant 42.7 HR 0.77 (0.57-1.05) Figure 5 (p.6)
M03 Time to definitive 10% deterioration (TTD) in Pain Severity Index (BPI-SF) Placebo + fulvestrant 35.9 - Figure 5 (p.6)
M04 Time to definitive 10% deterioration (TTD) in Fatigue (EORTC QLQ-C30) Ribociclib + fulvestrant 38.7 HR 0.91 (0.68-1.22) Figure 3 (p.5)
M04 Time to definitive 10% deterioration (TTD) in Fatigue (EORTC QLQ-C30) Placebo + fulvestrant 36.0 - Figure 3 (p.5)
M05 Change from baseline in EORTC QLQ-C30 pain scores (8 weeks) Ribociclib + fulvestrant -4.0 Diff -0.3 (CI -4.0 to 3.3) Page 5, Section 3.4 (p.5)
M05 Change from baseline in EORTC QLQ-C30 pain scores (8 weeks) Placebo + fulvestrant -3.6 - Page 5, Section 3.4 (p.5)
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