Theme


MONALEESA-3: QoL Analysis

Source
Source: Fasching PA, 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 delays deterioration while improving survival in HR+/HER2- Advanced Breast Cancer.

Population & Design

N = 726

Postmenopausal Women
Phase III, Randomized (2:1), Double-blind

Treatment Arms

  • Ribociclib + Fulv (n=484)
  • Placebo + Fulv (n=242)

Global Health Status

0.81
Hazard Ratio

Trend favoring Ribociclib for Time to Deterioration

Key QoL Outcomes

Emotional Functioning HR: 0.76

Maintained longer with combination therapy.

Pain Progression HR: 0.77

Significant delay in pain deterioration.

Note: Fatigue and physical scores remained comparable between arms.

Time to 10% Deterioration

Clinical Recommendation

Clinicians should confidently incorporate Ribociclib into regimens. Data confirms survival benefits without detriment to Quality of Life (HRQOL), validating it as a standard-of-care combination.

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; EOT, end of treatment; FUL, fulvestrant; GHS, global health status; HER2-, human epidermal growth factor receptor 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; HRQOL, health-related quality of life; LSM, least squares mean; OS, overall survival; PBO, placebo; PFS, progression-free survival; PRO, patient-reported outcome; QOL, quality of life; RIB, ribociclib; SD, standard deviation; SEM, standard error of the mean; 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)