Info
PALOMA-2
Palbociclib and Letrozole in Advanced Breast Cancer
- 在一項名為PALOMA-2的Phase 3的研究發現：針對未接受過進階治療的ER陽性、HER2陰性的乳腺癌患者，使用palbociclib加letrozole相較於僅使用letrozole，在 ✖ 無疾病進展生存期方面，分別是24.8個月對上14.5個月
- 此外，相比於對照組，使用palbociclib加letrozole的主要副作用有：中性球減少 ↓ 症 (66.4％ vs 1.4％) 、白細胞減少 ↓ 症 (24.8％ vs 0％) 、貧血 (5.4％ vs 1.8％) 和疲勞 (1.8％ vs 0.5％) 。
N Engl J Med 2016; 375:1925-1936
Palbociclib plus Letrozole for Advanced Breast Cancer: A Phase 3 Randomized Clinical Trial
- Design: Phase 3, double-blind, randomized clinical trial
- Number of patients: 666 postmenopausal women
- Patients characteristics: Postmenopausal women with estrogen-receptor (ER)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer, who had not had prior treatment for advanced disease
- Agent: Palbociclib plus Letrozole vs. Placebo plus Letrozole
- Treatment line: Initial treatment for advanced disease
- Trial Name/NCT Number: PALOMA-2 ClinicalTrials.gov number, NCT01740427
Comparison of Palbociclib plus Letrozole vs. Placebo plus Letrozole
| Endpoints | Palbociclib plus Letrozole | Placebo plus Letrozole |
|---|---|---|
| PFS | Median 24.8 months | Median 14.5 months (95% CI, 12.9 to 17.1) |
- Other findings:
- The most common grade 3 or 4 adverse events were neutropenia, leukopenia, anemia, and fatigue.
- Febrile neutropenia was reported in 1.8% of patients in the palbociclib-letrozole group and in none of the patients in the placebo-letrozole group.
- Permanent discontinuation of any study treatment as a result of adverse events occurred in 43 patients (9.7%) in the palbociclib-letrozole group and in 13 patients (5.9%) in the placebo-letrozole group.
Summary
Palbociclib plus Letrozole significantly improved progression-free survival in postmenopausal women with previously untreated ER-positive, HER2-negative advanced breast cancer compared to Letrozole alone. However, myelotoxic effects were higher with palbociclib-letrozole.
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