Abstract
Abstract Objective Vinflunine (VFL) is a novel microtubule inhibitor indicated in the treatment of advanced or metastatic urothelial transitional cell cancer after failure of a prior platinum-containing regimen at the recommended dose of 320mg/m² q3 weeks. This trial was designed to assess the pharmacokinetic (PK) behavior and tolerance of VFL in elderly patients (pts), and to propose dose-adjustments if necessary. Material and methods Three groups of cancer pts over 70years old (y) were open to recruitment: 70–75y, 75–80y and ≥80y. Each group of pts received intravenous VFL, respectively at 320, 280 and 250mg/m² on cycle 1. Pharmacokinetics and safety data were collected at cycle 1 and were compared to reference values from younger pts Results 46 pts were treated. For pts 70–75y and 75–80y, there was no statistically age-related change for VFL PK. For pts ≥80y, VFL blood total clearance (Cl tot ) was significantly decreased by 18%. The most common adverse events observed in this elderly population were not different from those seen in younger pts. No toxic death was recorded. Main toxicities were neutropenia (Grade 3/4: 73% of pts), constipation (all grade: 63%) and asthenia (all grade: 56%), without any relationship between the observed incidence and the ageing of pts. Conclusion Based on PK and safety data, a dose reduction at 280mg/m² and 250mg/m² is recommended in pts 75–80y and ≥80y respectively.
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