Table 1.
First-line randomized clinical trials testing chemotherapy in mUC.
| Author | Experimental arm | Control arm | Phase | n | ORR (%) | PFS (months) | OS (months) |
||
|---|---|---|---|---|---|---|---|---|---|
| Cisplatin-based treatment | Cisplatin-based combinations | Logothetis and colleagues19 | M-VAC | CISCA | 3 | 110 | 65 versus 46 | NR | 11.1 versus 8.3 |
| Loehrer and colleagues18; Saxman and colleagues20 | M-VAC | Cisplatin | 3 | 269 | 39 versus 12 | 10 versus 4.3 | 12.5 versus 8.2 | ||
| Von der Maase and colleagues5,35 | GC | M-VAC | 3 | 405 | 49 versus 46 (NS) |
7.4 versus 8.3 (NS) |
14 versus 15.2 (NS) |
||
| Sternberg and colleagues24,25 | DD-M-VAC | M-VAC | 3 | 263 | 64 versus 50 | 9.5 versus 8.1 | 15.1 versus 14.9 | ||
| Bamias and colleagues38 | DD-GC | DD-M-VAC | 3 | 130 | 65 versus 60 (NS) | 7.8 versus 8.5 (NS) |
18 versus 19 (NS) |
||
| Bellmunt and colleagues37 | PGC | GC | 3 | 626 | 55 versus 44 | 8.3 versus 7.6 (NS) | 15.8 versus 12.7 (NS) | ||
| Carboplatin versus cisplatin | Petrioli and colleagues41 | MVECa | MVEC | 2 | 57 | 41 versus 71 | 4.5 versus 8** | 9.5 versus 13 | |
| Bellmunt and colleagues39 | M-CAVI | M-VAC | 2 | 47 | 39 versus 52 (NS) | NR | 9 versus 16* | ||
| Dreicer and colleagues42 | Carbo-paclitaxel | M-VAC | 3 | 85 | 28 versus 36 (NS) | 5.2 versus 8.7 | 13.8 versus 15.4 (NS) | ||
| Dogliotti and colleagues40 | GCa | GC | 2 | 110 | 40 versus 49.1 | 7.7 versus 8.3 | 9.8 versus 12.8 | ||
| Unfit patients | De Santis and colleagues56 | GCa | M-CAVI | 2/3 | 238 | 41 versus 30 (NS)*** | 5.8 versus 4.2 p (NS) | 9.3 versus 8.1 (NS) | |
| De Santis (2015)61 | Vinflunine-gem | Vinflunine-carbo | 2 | 69 | 53 versus 43 (NS) | 5.9 versus 6.1 (NS) | 14 versus 12.8 (NS) | ||
carbo, carboplatin; CISCA, cisplatin, cyclophosphamide, and doxorubicin; DD, dose-dense; GC, gemcitabine and cisplatin; GCa, gemcitabine and carboplatin; gem, gemcitabine; mUC, metastatic urothelial cancer; M-CAVI, methotrexate, carboplatin, and vinblastine; M-VAC, methotrexate, vinblastine, doxorubicin, and cisplatin; MVECa, methotrexate, vinblastine, epirubicin, and carboplatin; MVEC, methotrexate, vinblastine, epirubicin, and cisplatin; NR, not reported; NS, difference not statistically significant; ORR, overall response rate; OS, overall survival; PFS, progression-free survival; PGC, paclitaxel plus GC.
based on median cancer-specific survival, OS not reported.
based on response duration, PFS not reported; ***ORR difference was statistically significant based on confirmed responses (36 versus 21%, p 0.01).