Info

🌱 來自: Metastatic Colon Cancer

VELOUR

• Design: Phase III, randomized, double-blind, multicenter trial
• Number of patients: 1226
• Patients characteristics: previously treated metastatic colorectal cancer,
  • including those who received prior bevacizumab
• Agent: aflibercept (4 mg/kg intravenously) or placebo every 2 weeks in combination with FOLFIRI
• Treatment line: second-line or later
• Trial Name/NCT Number: VELOUR/NCT00561470

Group	Progression-free survival (PFS)	Overall survival (OS)	Response rate (RR)
Aflibercept + FOLFIRI	6.90 months	13.50 months	19.8%
Placebo + FOLFIRI	4.67 months	12.06 months	11.1%

• Other findings:

  • Aflibercept significantly improved PFS and OS compared to placebo
  • Effects demonstrated consistent trend across prespecified subgroup analyses, including bevacizumab pretreated patients
  • Adverse effects included anti-vascular endothelial growth factor effects and increased incidence of some chemotherapy-related toxicities

• Summary: The VELOUR trial showed that adding aflibercept to FOLFIRI significantly improved PFS, OS, and response rate in patients with previously treated metastatic colorectal cancer, including those who received prior bevacizumab. The survival benefit was statistically significant and consistent across prespecified subgroup analyses. However, adverse effects were reported, including anti-vascular endothelial growth factor effects and increased incidence of some chemotherapy-related toxicities.

Addition of aflibercept to fluorouracil, leucovorin, and irinotecan improves survival in a phase III randomized trial in patients with metastatic colorectal cancer previously treated with an oxaliplatin-based regimen - PubMed