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
  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)
  2. 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)
  3. 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)
  4. 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)