Tolerability and incidence of infusion site reactions with emulsion formulation of vinorelbine (ANX-530) compared to vinorelbine solution

13549 Background: ANX-530 is an oil-in-water emulsion formulation of vinorelbine that has demonstrated less vein irritation, equivalent antitumor activity, and similar pharmacokinetic profiles to vinorelbine solution in preclinical studies. Pharmacokinetic equivalence to vinorelbine solution was recently reported in patients treated with each agent in a randomized clinical study. Methods: Thirty-one patients were enrolled in this single-dose 2-period crossover study, randomized for sequence. Patients had an advanced cancer potentially sensitive to vinorelbine after failure of standard treatments. Patients were randomly assigned to receive a single intravenous dose of either ANX-530 or vinorelbine in the first study period, then 1 week later, were crossed over to the other vinorelbine formulation. Both drugs were infused over 10 minutes at a dose of 30 mg/m2 using a calibrated syringe pump. Adverse events were analyzed by a logistic regression model with factors for treatment (ANX-530 vs. vinorelbine), per...