Theme

Ribociclib + Fulvestrant: Prolonged Survival, Preserved Quality of Life

Source
Source: Fasching PA, Beck JT, Chan A, et al. Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study. The Breast. 2020;54:148-154.

MONALEESA-3 Phase III Trial Analysis  |  HR+/HER2- Advanced Breast Cancer

Study Architecture

Population (N=726):
Postmenopausal, HR+/HER2- Advanced BC (1st or 2nd line).
Investigational (n=484):
Ribociclib + Fulvestrant
Control (n=242):
Placebo + Fulvestrant
0.81 Hazard Ratio

Global Health Status Maintenance

Reduced risk of definitive deterioration in QoL vs. Placebo (95% CI, 0.62–1.1). Added efficacy does not cost quality of life.

Time to Symptom Deterioration (HR)

Values < 1.0 indicate a delay in symptom worsening with Ribociclib.

QoL Stability Over Time

Symptom scores (e.g., fatigue, nausea) remained comparable to placebo.

Key Quality of Life Findings

  • Pain Progression Delayed: Favorable trend in delaying pain worsening (HR 0.77), reducing disease burden.
  • Symptom Burden Stability: Specific symptoms (fatigue, nausea, diarrhea) were maintained or slightly improved from baseline.
  • No Trade-off: Significant PFS gains (median 20.5 vs 12.8 mo) are achieved without compromising daily quality of life.

Clinical Recommendation

Integrate Ribociclib + Fulvestrant as a standard-of-care regimen for postmenopausal patients with HR+/HER2- advanced breast cancer.

Improve Survival Maintain QoL
AbbreviationsQuick
BPI-SF, Brief Pain Inventory-Short Form; CI, confidence interval; EORTC QLQ-C30, European Organisation for Research and Treatment of Cancer core quality-of-life questionnaire; GHS, global health status; HER2-, human epidermal growth factor receptor-negative; HR, hazard ratio; HR+, hormone receptor-positive; HRQOL, health-related quality of life; OS, overall survival; PFS, progression-free survival; PRO, patient-reported outcome; QOL, quality of life; TTD, time to definitive deterioration.
Bibliography1
  1. Fasching PA, Beck JT, Chan A, et al. Ribociclib plus fulvestrant for advanced breast cancer: Health-related quality-of-life analyses from the MONALEESA-3 study. The Breast. 2020;54:148-154. (DOI: 10.1016/j.breast.2020.09.008 | link)