Efficacy Without Compromise

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 Advanced Breast Cancer (MONALEESA-3)

Population (N=726)

Postmenopausal HR+/HER2-
Advanced Breast Cancer
(1st or 2nd Line)

Randomization (2:1)

Arm A: Ribociclib + Fulvestrant
Arm B: Placebo + Fulvestrant

0.81

HR (Global Health)

95% CI: 0.62–1.1

Quality of Life Data

No "QoL Tax" on Survival

Despite added toxicity risks of CDK4/6 inhibitors, Ribociclib did not accelerate deterioration.

Global Health Deterioration: 33% (Ribo) vs 34% (Placebo)

Pain Control HR 0.77 favoring Ribociclib delay in severity

Clinical Recommendation

Integrate Ribociclib + Fulvestrant into 1L/2L treatment plans. The significant OS/PFS benefits are achieved without compromising daily quality of life.

Time to Deterioration

Hazard Ratios < 1.0 favor Ribociclib

Definitive Deterioration Rate (Global Health)

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; 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; OS, overall survival; PBO, placebo; PFS, progression-free survival; PRO, patient-reported outcome; RIB, ribociclib; TTD, time to definitive deterioration.

Bibliography1

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)