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Table 3 Efficacy of vinflunine treatment in patients with advanced or metastatic transitional cell carcinoma of the urothelium treated with vinflunine after failure of a platinum-based chemotherapy

From: Real-life clinical practice results with vinflunine in patients with relapsed platinum-treated metastatic urothelial carcinoma: an Italian multicenter study (MOVIE-GOIRC 01–2014)

Parameter Present study Registration study
N of randomly assigned patients NA 253
N (%) 217 (100) 185 (73a)
Overall response, n (%)
 CR 6 (3) 0 (0)
 PR 21 (10) 16 (9)
 SD 60 (28) 86 (46)
 PD 108 (50) NR
 DCR
 Not evaluable (or Missing data)
87 (40)
22 (10)
104 (41b)
-
 Objective response rate, n (%) 27 (13) 16 (9)
PFS, months
 Median [95% CI] 3.2 [2.6–3.7] 3.0 [2.1–4]
OS, months
 Median [95% CI] 8.1 [6.3–8.9] 6.9 [5.7–8.0]
  1. CR complete response, DCR disease control rate, OS overall survival, PD progressive disease, PFS progression-free survival, PR partial response, NR not reported, NA not applicable
  2. aEvaluable patients for response rate
  3. bCalculated on Intention to treat population