2 The technology
2.1 Vinflunine (Javlor, Pierre Fabre) is a chemotherapeutic agent belonging to the vinca-alkaloid class of drugs. Vinflunine has a marketing authorisation for use as 'monotherapy for the treatment of adult patients with advanced or metastatic transitional cell carcinoma of the urothelial tract after failure of a prior platinum-containing regimen'. The summary of product characteristics (SPC) notes that vinflunine has not been studied in patients with a performance status of 2 or more.
2.2 According to the SPC, common undesirable effects associated with vinflunine include haematological disorders (neutropenia and anaemia), gastrointestinal disorders (constipation, nausea, stomatitis, vomiting, abdominal pain and diarrhoea), and general disorders (asthenia/fatigue). For full details of side effects and contraindications, see the SPC.
2.3 The SPC states that the recommended dosage of vinflunine is 320 mg/m2 as a 20-minute intravenous infusion every 3 weeks. The SPC also states that in patients with a World Health Organization (WHO)/Eastern Cooperative Oncology Group (ECOG) performance status of 1 or of 0 who have had pelvic irradiation, treatment should be started at a dose of 280 mg/m2; in the absence of any haematological toxicity during the first cycle causing treatment delay or dose reduction, the dosage can be increased to 320 mg/m2 every 3 weeks for the subsequent cycles. The SPC states that monitoring of complete blood counts should be conducted before each treatment cycle, and that oral hydration and laxatives should be given during each cycle. Vinflunine is available in 50 mg and 250 mg vials, costing £212.50 and £1062.50 respectively (excluding VAT; 'British National Formulary' edition 64). The acquisition cost of vinflunine for an entire course of treatment is £9817.50, assuming an average of 4.2 cycles, a dose of 287 mg/m2 and a body surface area of 1.85 m2 (see section 3.10). Costs may vary in different settings because of negotiated procurement discounts.