Ribociclib + Fulvestrant: Significant Survival Gains Without Compromising 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 Analysis: Efficacy & QOL in Postmenopausal HR+/HER2- Advanced Breast Cancer

Study Design

N = 726 (Postmenopausal, 1st/2nd Line)

Arm	n	Dosing
Ribociclib + Fulv.	484	600mg (3w on/1w off)
Placebo + Fulv.	242	Placebo + 500mg

Median Follow-up: 20.4 months

Time to Global Health Deterioration

0.81

Hazard Ratio (HR)

Favorable trend delaying QOL deterioration (95% CI: 0.62–1.1).

Recommendation

Incorporate Confidently. Treatment intensification with Ribociclib achieves significant survival gains without negatively impacting daily functioning.

PFS HR: 0.59 OS HR: 0.72 QOL Maintained

Patient-Reported Outcomes (HR)

Hazard Ratios < 1.0 indicate delayed deterioration with Ribociclib.

Holistic Benefit Profile

Comparing Efficacy gains (PFS/OS) with Safety/QOL stability.

Symptom Burden Details

Pain Control

Reduction noted as early as 8 weeks. "Worst pain" scores consistently trended favorably (HR 0.81).

Symptom Stability

Fatigue, diarrhea, and nausea scores were maintained or improved, showing no significant worsening vs. placebo.

Definitive Deterioration

Time to ≥10% deterioration in Global Health Status was delayed by addition of Ribociclib.

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 2-negative; HR, hazard ratio; HR+, hormone receptor-positive; HRQOL, health-related quality of life; OS, overall survival; PBO, placebo; PFS, progression-free survival; PRO, patient-reported outcome; RIB, ribociclib; SD, standard deviation; TTD, time to definitive deterioration.

Bibliography3

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 54 (2020) 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):2465-72. (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):514-24. (DOI: 10.1056/NEJMoa1911149 | link)