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 |
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Authors: | Paul Ruff Eric Van Cutsem Radek Lakomy Jana Prausova Guy A van Hazel Vladimir M Moiseyenko Karen Soussan-Lazard Emmanuelle Dochy Emmanuelle Magherini Teresa Macarulla Demetris Papamichael |
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Institution: | 1. University of Witwatersrand Faculty of Health Sciences, Johannesburg, South Africa;2. University Hospitals Leuven and KU Leuven, Belgium;3. Masaryk Memorial Cancer Institute, Brno, Czech Republic;4. University Hospital Motol, Prague, Czech Republic;5. University of Western Australia, Western Australia, Australia;6. Cancer Center, St-Petersburg, Russian Federation;7. Sanofi, Vitry-sur-Seine, France;8. Sanofi, Diegem, Belgium;9. Vall d''Hebron University Hospital and Institute of Oncology (VHIO), Barcelona, Spain;10. Bank of Cyprus Oncology Centre, Nicosia, Cyprus |
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Abstract: | ObjectivesAflibercept (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.MethodsEfficacy and safety were analyzed by treatment arm and age (≥ or < 65 years).ResultsOverall, 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).ConclusionA 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. |
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Keywords: | Elderly Aflibercept mCRC Second-line VEGF-Trap VELOUR |
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