Info

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

PALOMA-3

• Overall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer
• N Engl J Med 2018; 379:1926-1936

The Effect of Palbociclib on Overall Survival in Hormone-Receptor-Positive, HER2-Negative Advanced Breast Cancer: A Prespecified Analysis by Endocrine Sensitivity, Visceral Metastases, and Age

1. Design:

   • Phase: III
   • Randomized
   • Double-blind
   • Multicenter

2. Number of Patients: 521

3. Patients Characteristics:

   • Hormone-receptor-positive
   • HER2-negative
   • Advanced breast cancer
   • Progression or relapse during previous endocrine therapy

4. Agent:

   • Palbociclib plus fulvestrant or placebo plus fulvestrant

5. Treatment Line: Advanced breast cancer

6. Trial Name: PALOMA-3 (NCT01942135)

7. Comparison of two groups:

   Outcome Measure	Palbociclib-Fulvestrant	Placebo-Fulvestrant
   Progression-free survival	9.5 months	4.6 months
   Overall survival	34.9 months	28.0 months
   Response rate	42.1%	28.3%

8. Other findings:

   • No new safety signals were observed with 44.8 months of follow-up.
   • The median duration of subsequent therapy was similar in the two groups.
   • The median time to receipt of chemotherapy was 17.6 months in the palbociclib-fulvestrant group, compared with 8.8 months in the placebo-fulvestrant group.

9. Summary: The clinical trial results demonstrate that treatment with palbociclib-fulvestrant resulted in significantly longer overall survival in patients with hormone-receptor-positive, HER2-negative advanced breast cancer who had sensitivity to previous endocrine therapy. The study provides evidence for the use of palbociclib in combination with fulvestrant as a standard treatment option for this patient population.