Table 3.
Second-line randomized clinical trials with chemotherapy in mUC.
| Author [Year] | Experimental arm | Control arm | Phase | n | ORR (%) | PFS/TTP* (months) | OS/CSS**
(months) |
|
|---|---|---|---|---|---|---|---|---|
| Chemotherapy (CT) alone | Fechner and colleagues94 | Gem-paclitaxel q2w cont | Gem-paclitaxel q3w x6 | 2 | 30 | 39 versus 50 | 6 versus 11 (NS) | 9 versus 13 (NS) |
| Albers (2010)93 | Gem-paclitaxel q3w cont | Gem-paclitaxel q3w x6 | 3 | 102 | 41.5versus 37.5 (NS) | 3.1 versus 4 (NS) | 8 versus 7.8 (NS) | |
| Bellmunt and colleagues6,79 | Vinflunine | BSC | 3 | 370 | 8.6 versus 0 | 3 versus 1.5 | 6.9 versus 4.6† (NS) | |
| Bellmunt and colleagues99 | Cabazitaxel | Vinflunine | 2 | 70 | 13 versus 30 (NS) | 1.9 versus 2.9 | 5.5 versus 7.6 (NS) | |
| Sridhar and colleagues96 | Nab-paclitaxel | Paclitaxel | 2 | 160 | 22 versus 25 | 3.35 versus 3.02 (NS) | 7.46 versus 8.77 (NS) | |
| CT + targeted therapy | Choueiri and colleagues84 | Docetaxel-vandetanib | Docetaxel | 2 | 142 | 7 versus 11 | 2.56 versus 1.58 (NS) | 5.85 versus 7.03 (NS) |
| Petrylak and colleagues86 | Docetaxel-ramucirumab | Docetaxel | 3 | 530 | 24.5 versus 14 | 4.07 versus 2.76 | NR | |
| Rosenberg and colleagues151
|
Docetaxel-apatorsen | Docetaxel | 2 | 99 | 16 versus 11 (NS) | 1.8 versus 1.6 (NS) | 6.4 versus 5.9 |
BSC: best supportive care; CSS: cancer-specific survival; CT, chemotherapy; gem, gemcitabine; mUC, metastatic urothelial cancer; NR, not reported; NS, difference not statistically significant; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; TTP, time to progression.
*
TTP reported when PFS data is not available.
**
CSS reported when OS not available.
†
Results from the intention-to-treat population.