Table 1.
Characteristics of patients (n = 23).
Responders | Non-Responders (n = 11) | Global | p Value | |
---|---|---|---|---|
(n = 12) | (n = 23) | |||
Male (%)/Female (%) | 11 (19%)/1 (9%) | 8 (72%)/3 (28%) | 19 (82%)/4 (18%) | 0.23 |
Age media (SD) | 67 (9.2) | 66 (11.4) | 66 | 0.57 |
Smokers | 8 (66%) | 7 (63%) | 15 (65%) | 0.54 |
Urothelial carcinoma | 12 (100%) | 11 (100) | 100 (100%) | |
1 Line | ||||
0 | 6 (50%) | 5 (45%) | 11 (48%) | |
1 | 6 (50%) | 5 (45%) | 11 (48%) | |
2 | 0 | 1 (10%) | 1 (4%) | 0.56 |
Prior platinum based CT | ||||
Cisplatin | 10 (83%) | 5 (45%) | 15 (65%) | |
Carboplatin | 2 (17%) | 6 (55%) | 8 (35%) | 0.06 |
Response to platinum based CT | ||||
Partial response | 1 (8%) | 5 (45%) | 6 (26%) | |
Stable disease | 6 (50%) | 5 (45%) | 11 (48%) | |
Progressive disease | 5 (42%) | 1 (9%) | 6 (26%) | 0.06 |
Number of line for vinflunine | ||||
2 | 9 (81%) | 10 (90%) | 19 (83%) | |
3 | 1 (8%) | 1 (9%) | 2 (8.6%) | |
4 | 2 (16%) | 0 | 2 (8.6%) | 0.36 |
Location of metastases | ||||
Lung | 5 (42%) | 4 (36%) | 9 (39%) | 0.79 |
Lymph nodes | 9 (81%) | 7 (27%) | 16 (69%) | 0.55 |
Liver | 1 (8%) | 3 (45%) | 4 (17%) | 0.23 |
Bone | 4 (36%) | 5 (27/) | 9 (39%) | 0.52 |
Median PFS (months) of vinflunine treatment (CI 95%) | 10 (8.7–11.5) | 2.2 (1.8–2.5) | 6 (0–15.5) | 0.02 |
Median OS (months) of vinflunine treatment | 19.9 (10.7–29.0) | 2.5 (2.1–2.8) | 11.5 (3.4–19.5) | 0.06 |
PFS: progression-free survival; OS: overall survival; CI: confidence interval.