There is no standard of care currently in UK for second line chemotherapy for patients with advanced TCC. Vinflunine is approved for TCCU for patients who have failed a platinum-based regimen and is now the standard chemotherapy in 2nd line in Europe based on large phase III randomised trial data showing 2.6 months survival advantage. ESMO guidelines recommended it as the only option for patients in the 2nd line setting. Vinflunine is not currently available in NHS practice in UK as it is not on the approved list of drugs on cancer drug fund.
Data are collected retrospectively on patients who received Vinflunine as a 2nd line treatment through FOCP. The dose of Vinflunine was 320/280/240 mg/m2 every 3 weeks as per the SPc. The aim was to document the toxicity, radiological RR and OS in a real life setting within the FOCP.
Data were collected on 49 patients from 9 sites across the UK and Ireland (median age: 64 (IQR: 57-70) years, 33 males ). All patients had advanced metastatic TCCU. Thirteen patients had bone or liver metastases, 4 patients had PS 2 and 11 patients had HB
Real life data reveal a median OS of 9.1 m by ITT for all patients which is consistent with real life data from Europe (Spanish, German and French) presented at ESMO 2013. Toxicity has been further reduced with the use of prophylactic laxative and oral antibiotics. Vinflunine is an efficient and tolerable second line treatment in advanced TCCU.
Clinical trial identification
Legal entity responsible for the study
University of Liverpool
All authors have declared no conflicts of interest.