Info
MONALEESA-3
Overall Survival with Ribociclib plus Fulvestrant in Advanced Breast Cancer
在一項名為MONALEESA-3的Phase 3研究的第二次中期分析中發現：針對ER陽性、HER2陰性的進階乳腺癌患者，使用ribociclib加fulvestrant相較於僅使用fulvestrant，在總體生存期上有顯著的益處
- 在於42個月時的預估總體生存率，ribociclib組為57.8％ (95％信賴區間[CI]為52.0％至63.2％) ，而安慰劑組為45.9％ (95％ CI為36.9％至54.5％) ，相對風險的死亡率下降 ↓ 了28％ (風險比為0.72；95％ CI為0.57至0.92；P = 0.00455)
- 此外，在接受第一線治療的患者中，使用ribociclib加fulvestrant的中位 ✖ 無疾病進展生存期為33.6個月 (95％ CI為27.1至41.3) ，而在安慰劑組中為19.2個月 (95％ CI為14.9至23.6) 。
Ribociclib plus Fulvestrant for Advanced Breast Cancer: A Phase 3 Randomized Clinical Trial
- Design: Phase 3, randomized clinical trial
- Number of patients: Not reported
- Patients characteristics: Postmenopausal patients with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, receiving first-line or second-line treatment
- Agent: Ribociclib plus Fulvestrant vs. Placebo plus Fulvestrant
- Treatment line: First-line or second-line treatment
- Trial Name/NCT Number: MONALEESA-3 ClinicalTrials.gov number, NCT02422615
Comparison of Ribociclib plus Fulvestrant vs. Placebo plus Fulvestrant
| Endpoints | Ribociclib plus Fulvestrant | Placebo plus Fulvestrant |
|---|---|---|
| PFS (first-line treatment) | Median 33.6 months (95% CI, 27.1 to 41.3) | Median 19.2 months (95% CI, 14.9 to 23.6) |
| Overall survival | 42 months was 57.8% | 45.9% |
| Response rate | Not reported | Not reported |
- Other findings:
- No new safety signals were observed.
Summary
Ribociclib plus Fulvestrant significantly improved overall survival compared to Placebo plus Fulvestrant in postmenopausal patients with hormone-receptor-positive, HER2-negative advanced breast cancer receiving first-line or second-line treatment. The benefit was consistent across most subgroups. Median progression-free survival was also improved in patients receiving first-line treatment. No new safety signals were observed.