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. Issue 1 (January 2018)

• Record Type: Journal Article
• Authors: Ruff, Paul; Van Cutsem, Eric; Lakomy, Radek; Prausova, Jana; van Hazel, Guy A.; Moiseyenko, Vladimir M.; Soussan-Lazard, Karen; Dochy, Emmanuelle; Magherini, Emmanuelle; Macarulla, Teresa; Papamichael, Demetris
• Is Part Of: Journal of geriatric oncology. Volume 9:Issue 1(2018)
• Page Start: 32
• Page End: 39
• Publication Date: 2018-01
• Subjects: Elderly -- Aflibercept -- mCRC -- Second-line -- VEGF-Trap -- VELOUR; Geriatric oncology -- Periodicals; Neoplasms -- Periodicals; Aged -- Periodicals; Geriatric oncology; Electronic journals; Periodicals; 618.976994005
• DOI: 10.1016/j.jgo.2017.07.010
• Languages: English
• ISSNs: 1879-4068

Abstract

Abstract: 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). Results: Overall, 443 patients were ≥ 65 years old (205 in aflibercept arm; 238 in placebo arm) and 783 were < 65 years old (407 in aflibercept arm; 376 in placebo arm). Median OS was 12.6 versus 11.3 months (hazard ratio [HR]: 0.85; 95.34% CI 0.68–1.07) in patients ≥ 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, for patients receiving FOLFIRI plus aflibercept or placebo, respectively. There was no interaction between treatment and age. Treatment-emergent adverse events (AEs) were comparable for patients < 65 years and ≥ 65 years old. The incidence of grade 3/4 AEs was higher for patients ≥ 65 years old than for those < 65 years old in both the aflibercept (89.3% versus 80.5%) and placebo (67.4% versus 59.4%) arms. Interaction tests for grade 3/4 antiangiogenic agent-related AEs suggested no heterogeneity between the older and younger patient populations (p > 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 and ≥ 65 years old, with a marked but manageable increase in the toxicity profile in older patients. Trial Registration: clinicaltrials.gov NCT00561470