Info

🌱 來自: Hormone-receptor positive (HER2 negative)-of-metastatic breast cancer

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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