Theme

MONALEESA-3: Quality of Life Analysis

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.

Ribociclib + Fulvestrant in HR+/HER2- Advanced Breast Cancer

Population

726 Postmenopausal Women
HR+/HER2- Advanced BC
(1st or 2nd Line)

Investigational Arm

Ribociclib (600mg)
+ Fulvestrant
(n=484)

Control Arm

Placebo
+ Fulvestrant
(n=242)

Hazard Ratio
0.81
95% CI: 0.62–1.1
Global Health Status

Key Takeaway: Adding Ribociclib delays the deterioration of overall quality of life compared to endocrine therapy alone.

Specific Deterioration Delays

QoL Maintenance

Defined as ≥10% deterioration. Ribociclib did not increase the rate of definitive health status deterioration despite additional toxicity.

Pain Control: Time to deterioration in pain favored Ribociclib (HR=0.77), suggesting better long-term symptom control.

Clinical Recommendation

Clinicians should confidently integrate Ribociclib with Fulvestrant. This combination delivers significant efficacy (PFS & OS) without compromising Health-Related Quality of Life, while effectively delaying deterioration in physical/emotional functioning and pain.

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 2; HR, hazard ratio; HR+, hormone receptor-positive; HRQOL, health-related quality of life; OS, overall survival; PFS, progression-free survival; PRO, patient-reported outcome; TTD, time to definitive deterioration.
Bibliography8
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