Theme

MONALEESA-3 PRO Analysis

Source
Source: MONALEESA-3 study. Fasching PA, et al. The Breast. 2020;54:148-154.

Ribociclib + Fulvestrant Maintains Quality of Life While Extending Progression-Free Survival

Population

N=726 Postmenopausal women.
HR+/HER2- Advanced Breast Cancer.

1st/2nd Line or Early Relapse

Investigational

Ribociclib (600 mg) + Fulvestrant

n = 484

Control

Placebo + Fulvestrant

n = 242

Preservation of Health Status

19%
Reduction in Risk
of Definitive QOL Deterioration
Emotional Functioning: HR 0.76 (Trend to delayed deterioration)
Pain Severity: HR 0.77 (Pain control maintained)

Time to Definitive 10% Deterioration (HR)

Favors Ribociclib  |  Favors Placebo

Symptom Burden Profile

Despite the addition of a CDK4/6 inhibitor, reported symptom scores for fatigue, nausea, and vomiting were similar to the Placebo arm.

Consistent with EORTC

Clinical Recommendation

Integrate Ribociclib + Fulvestrant into first- and second-line plans. The regimen delivers significant PFS/OS gains without compromising daily quality of life. Emphasize to patients that physical and emotional functioning remains comparable to endocrine monotherapy.

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–negative; HR, hazard ratio; HR+, hormone receptor–positive; HRQOL, health-related quality of life; OS, overall survival; PFS, progression-free survival; PRO, patient-reported outcome; QOL, quality of life; TTD, time to definitive deterioration.
Bibliography3
  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)
  2. 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)
  3. 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)