Table 2.
Trials of single agents in second-line treatment of advanced or metastatic urothelial carcinoma
| Agent | No of evaluable patients | ORR: patients responding (%) | Median TTP (months) | Median OS (months) | Main grade 3–4 toxicities: no patients (%) | Reference |
|---|---|---|---|---|---|---|
| Vinflunine | 51 | 9 (18%) | 3.0 | 6.6 | 34 (67%) neutropenia; 23 (45%) leukopenia; 7 (14%) anemia |
Culine82 |
| Vinflunine | 151 | 22 (15%) | 2.8 | 8.2 | 86 (58.1%) neutropenia; 73 (49%) leukopenia; 23 (16%) anemia |
Vaughn83 |
| Vinflunine | 370 | 16 (8.6%) | 3.0 | 6.9 | 123 (50%) neutropenia; 47 (19%) anemia |
Bellmunt81 |
| Vinblastine | 28 | 5 (18%) | N/A | N/A | N/A | Blumenreich28 |
| Paclitaxel | 14 | 1 (7.1%) | N/A | N/A | Hematological toxicities in 23 of 42 courses; 2 (14%) with other grade 3–4 toxicities | Papamichael21 |
| Paclitaxel | 31 | 3 (10%) | 2.2 | 7.2 | 4 (13%) anemia; 2 (7%) asthenia | Vaughn22 |
| Paclitaxel | 45 | 4 (9%) | 3 | 7 | N/A | Joly23 |
| Docetaxel | 30 | 4 (13.3%) | N/A | 9 | 18 (60%) | McCaffrey20 |
| Ifosfamide | 20 | 1 (5%) | 6.0 | 8.0 | 2 (10%) | Pronzato87 |
| Ifosfamide | 56 | 11 (20%) | 2.2 | 5.1 | N/A | Witte88 |
| Topotecan | 44 | 4 (9.1%) | 1.4 | 6.3 | 34 (77%) leukopenia; 27 (61%) anemia; 19 (43%) thrombocytopenia |
Witte89 |
| Pyrazoloacridine | 14 | 0 | N/A | 9 months | 8 (57%) neutropenia; 2 (14%) thrombocytopenia |
Dodd90 |
| Piritrexim | 27 | 2 (7%) | 2.1 | 7.0 | 4 (15%) thrombocytopenia; 3 (11%) anemia; 5 (19%) neuropathy; 2 (7%) hepatotoxicity; 2 (7%) nausea |
Roth91 |
| Piritrexim | 22 | 0 | N/A | N/A | 6 (27%) | Lassiter92 |
| Oxaliplatin | 20 | 1 (5%) | N/A | N/A | 11 (55%) | Winquist93 |
| Pemetrexed | 47 | 13 (27.7%) | 2.9 | 9.6 | 4 (9%) thrombocytopenia; 4 (9%) neutropenia; 2 (4%) anemia; 3 (6%) fatigue; 2 (4%) diarrhea |
Sweeney24 |
| Pemetrexed | 12 | 1 (8%) | N/A | N/A | 3 (23%) anemia; 3 (23%) neutropenia; 3 (23%) thrombocytopenia | Galsky25 |
| Bortezomib | 21 | 0 | 1.9 | 3.5 | 15 (71%) | Gomez-Abuin26 |
| Bortezomib | 25 | 0 | 1.4 | 5.7 | 5 (21%) hematological toxicity | Rosenberg27 |
| Gemcitabine | 44 | 11 (25%) | 3.1 | 12.6 | 21 (48%) neutropenia; 4 (9%) anorexia | Akaza94 |
| Epothilone B analog BMS-247550 (ixabepilone) | 45 | 5 (11.9%) | 2.7 | 8.0 | 16 (36%) granulocytopenia; 5 (11%) thrombocytopenia; 3 (7%) sensory neuropathy; 5 (11%) fatigue; 4 (9%) dehydration |
Dreicer95 |
| Irinotecan | 40 | 2 (5%) | 2.1 | 5.4 | N/A | Beer96 |
| Lapatinib | 59 | 1 (1.7%) | 2.0 | 4.1 | 4 (7%) vomiting; 2 (3%) diarrhea; 2 (3%) dehydration; 2 (3%) hyponatremia |
Wulfing85 |
Abbreviations: N/A, not available or not reported; ORR, overall response rate; OS, overall survival; TTP, time to progression.