VICTOR: Vinflunine (Vin) in advanced metastatic transitional cell carcinoma of the urothelium (TCCU)—A retrospective analysis of use of Vin in multicenter, real life setting as second-line chemotherapy (ChT) through free-of charge-programme (FOCP) for patients (pts) in the UK.

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352 Background: There is no standard of care currently in UK for second line ChT for pts with advanced TCC. Vin is approved for TCCU for pts who have failed a platinum-based regimen and is now the standard ChT 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 pts in the 2nd line setting. Vin is not currently available in NHS practice in UK as it is not on the approved list of drugs on cancer drug fund. Methods: Data are collected retrospectively on pts who received Vin as a 2nd line treatment through FOCP. The dose of Vin was 240-320 mg/m2 every 3 weeks. The aim was to document the toxicity, radiological RR and OS for pts treated with Vin in real life setting within the FOCP. Results: At the time of analysis data from 37 pts from 6 sites were available. Median pts age was 64 years(range: 57-69), 24m; 13 f. All pts had advanced metastatic TCC. 9 pts had bone or liver mets, 3 pts had PS 2 and 5 pts had HB <10, all known poor prognostic indicators in palliative ChT setting. Total of 179 cycles have been delivered (median 3 ; mean 5; range1-16). Grade 3 / 4 toxicity: Anaemia 2/179, Neutropenia 2/179, Neutropenic infection 2/179, Constipation 4/179, Fatigue 3/179. Grade 2 toxicity; Anaemia 5/179, Neutropenia 13/179, Thrombocytopenia 2/179, Febrile infection 1/179, Constipation 9/179, Fatigue 20/179, Abdominal pain 2/179, Vomiting 8/179. 30 pts were evaluable for response. 11 pts had PR, 6 had SD, 13 had PD and 7 were not evaluable. Partial RR was 30 % with ITT and 37% for evaluable pts. Median OS was 9.5 (95% CI; 5.9- 16.9) months. Conclusions: Real life data showing a median OS of 9.5 m by ITT for all pts are encouraging and consistent with real life data from Europe (Spanish, German and French) presented at ESMO 2013. Toxicity has further improved with the use of prophylactic laxatives and oral antibiotics.

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