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
Study Architecture
Population (N=726): Postmenopausal, 1L or 2L.
Investigational (n=484)
Ribociclib + Fulv
Control (n=242)
Placebo + Fulv
0.81
Hazard Ratio (95% CI: 0.62–1.1)
Significant delay in definitive global health deterioration.
Time to Deterioration
Hazard Ratio < 1.0 favors Ribociclib arm.
Symptom Scores Over Time
Scores remained stable and comparable to placebo.
Key Findings
- Preserved QoL: No detriment to general health vs endocrine therapy alone.
- Pain Control: Delayed time to pain deterioration (HR 0.77).
- Adverse Events: Fatigue/nausea scores comparable to placebo.
Clinical Recommendation
Confident Prescription: Strong benefit-risk profile.
Counsel patients that Ribociclib + Fulvestrant extends survival without compromising daily Quality of Life or worsening pain compared to hormone therapy.
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; FUL, fulvestrant; HER2-, human epidermal growth factor receptor-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.
Bibliography4
- 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)
- Slamon DJ, Neven P, Chia S, et al. Phase III randomized study of ribociclib and fulvestrant in hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer: MONALEESA-3. J Clin Oncol 2018;36(24):2465-2472. (DOI: 10.1200/JCO.2018.78.9909 | link)
- Slamon DJ, Neven P, Chia S, et al. Overall survival with ribociclib plus fulvestrant in advanced breast cancer. N Engl J Med 2020;382(6):514-524. (DOI: 10.1056/NEJMoa1911149 | link)
- Cardoso F, Senkus E, Costa A, et al. 4th ESO-ESMO international consensus guidelines for advanced breast cancer (ABC 4). Ann Oncol 2018;29(8):1634-1657. (DOI: 10.1093/annonc/mdy192 | link)
👀 View Mode