602PSafety and effectiveness of aflibercept + FOLFIRI for the treatment of patients with metastatic colorectal cancer (mCRC): OZONE secondary analyses

Abstract Background For patients with mCRC that have failed a first-line oxaliplatin-based regimen, the preferred treatment option is an irinotecan-based regimen. In these secondary analyses of the OZONE study, aflibercept + FOLFIRI safety and efficacy was evaluated for sub-populations of patients with mCRC. Methods OZONE is a prospective, multicentre, observational, non-comparative study evaluating patients receiving aflibercept + FOLFIRI in the clinical setting, for 24 months from aflibercept initiation or until death. Patients were grouped according to: age (≥ 65 years vs UNL or AST/ALT > 1.5 UNL) impairment; number and type of prior anti-cancer therapy. Results From the overall population (N = 766), there were 370 patients aged ≥ 65 years. All grade asthenia (43.5% vs 35.9%) and decreased appetite (25.4% vs 20.2%) occurred more frequently (≥ 5%) in patients aged ≥ 65 vs 80 mL/min, respectively. There were 129 patients with impaired liver function. All grade constipation and haemorrhage were more frequent in patients with impaired liver function vs those without (23.3% vs 14.2% and 37.2% vs 30.1%, respectively). There were 449 patients previously treated with bevacizumab. Only fatigue occurred more frequently in patients with prior bevacizumab vs those without (23.8% vs 17.0%). Efficacy multivariate analyses showed that treatment with aflibercept + FOLFIRI favoured patients without vs with hepatic impairment (median overall survival [OS] 13.7 vs 8.7 months; p