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

MONALEESA-3: HRQOL Analysis

Impact of Ribociclib plus Fulvestrant on Time to Deterioration in Health-Related Quality of Life

Year: 2020 Model: HR+/HER2- Advanced Breast Cancer N: 726

Study Design

Model: Patients
Disease/Injury: HR+/HER2- advanced breast cancer
Duration: Median follow-up 20.4 months

A randomized (2:1), double-blind, placebo-controlled trial comparing Ribociclib (600 mg/day) plus Fulvestrant (500 mg) against Placebo plus Fulvestrant.

Methods:
EORTC QLQ-C30 questionnaire Brief Pain Inventory-Short form (BPI-SF) Time to definitive 10% deterioration (TTD) analysis Stratified Cox regression for Hazard Ratios

Time to Deterioration: Hazard Ratios

Hazard Ratios for time to definitive 10% deterioration across global health, functioning, and pain domains. Values < 1.0 favor Ribociclib.

Baseline Global Health Status

Comparison of baseline Global HRQOL scores between treatment arms to establish comparability.

Baseline Pain Scores

Comparison of baseline pain scores (EORTC QLQ-C30) between treatment arms.

Functional Preservation (HR)

Relative risk of deterioration in Physical vs. Emotional functioning. Lower values indicate better preservation with Ribociclib.

Pain Severity Deterioration Risk

Focused view on the Hazard Ratio for time to deterioration in the BPI-SF Pain Severity Index.

Summary & Data

Key Takeaways

✓ Ribociclib plus fulvestrant showed a trend toward delaying deterioration in Global Health Status (HR 0.81).
✓ Emotional functioning was the most preserved domain relative to placebo (HR 0.76).
✓ Baseline scores for Global Health and Pain were comparable between the two study arms.

Limitations

  • Differences in Time to Deterioration (TTD) were not statistically significant as Confidence Intervals crossed 1.
  • No post-progression patient-reported outcome assessments were performed.

Raw Data Table

Sources / Provenance

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