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
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] |