Observed benefit and safety of aflibercept in elderly patients with metastatic colorectal cancer: An age-based analysis from the randomized placebo-controlled phase III VELOUR trial
Abstrakt
Objectives: Aflibercept (ziv-aflibercept) significantly improves progression-free (PFS) and overall survival (OS) when added to 5-fluorouracil, leucovorin and irinotecan (FOLFIRI), compared with FOLFIRI alone, in patients with metastatic colorectal cancer previously treated with oxaliplatin-based therapy. This subset analysis of the VELOUR study investigates aflibercept plus FOLFIRI versus placebo plus FOLFIRI according to age.
Methods: Efficacy and safety were analyzed by treatment arm and age (>= or = 65 years old and 14.5 versus 12.5 months (HR: 0.80; 95.34% CI 0.67-0.95) in those patients = 65 years old. The incidence of grade 3/4 AEs was higher for patients >= 65 years old than for those 0.1).
Conclusion: A limited but consistent benefit on both OS and PFS was associated with the addition of aflibercept to FOLFIRI compared with placebo in patients = 65 years old, with a marked but manageable increase in the toxicity profile in older patients.