Theme

MONALEESA-3: Quality of Life & Pain Outcomes

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

Population

726 Postmenopausal women
HR+/HER2- Advanced BC
(1st Line or 2nd Line/Early Relapse)

Design

Phase III, Randomized (2:1)
Arm A: Ribociclib + Fulvestrant
Arm B: Placebo + Fulvestrant

Assessment

PRO Tools: EORTC QLQ-C30 & BPI-SF
Every 8 weeks (first 18 mos), then every 12 weeks.

Time to Deterioration
0.81
Hazard Ratio (Global Health Status)
19% Risk Reduction vs Placebo

Hazard Ratios: Time to 10% Deterioration

Global Health

Maintained scores similarly to placebo. Trend toward delayed deterioration.

HR = 0.81 [0.62–1.1]
Pain Management

Delayed worsening of pain symptoms. 23% reduction in risk of pain deterioration.

HR = 0.77 [0.57–1.05]
Emotional Stability

Despite cytotoxic addition, trend favors Ribociclib with 24% reduction in functional risk.

HR = 0.76 [0.57–1.01]

Clinical Recommendation

Clinicians can confidently position Ribociclib + Fulvestrant as a regimen that significantly extends survival (PFS 20.5m vs 12.8m) without accelerating quality of life deterioration. Use this PRO data to address patient concerns regarding tolerability; the addition of toxicity does not compromise functional status or pain control.

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; 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)
  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)
  4. Im SA, Lu YS, Bardia A, et al. Overall survival with ribociclib plus endocrine therapy in breast cancer. N Engl J Med. 2019;381(4):307-316. (DOI: 10.1056/NEJMoa1903765)