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- Title
Phase 2 trial of sorafenib in patients with advanced urothelial cancer: a trial of the Eastern Cooperative Oncology Group.
- Authors
Dreicer R; Li H; Stein M; Dipaola R; Eleff M; Roth BJ; Wilding G; Dreicer, Robert; Li, Hailun; Stein, Mark; DiPaola, Robert; Eleff, Michael; Roth, Bruce J; Wilding, George
- Abstract
<bold>Background: </bold>There is no effective second-line systemic chemotherapy for patients with disease progression after cisplatin-based chemotherapy. A phase 2 trial of sorafenib was performed to determine the activity and toxicity of this agent in a multi-institutional setting in patients previously treated with 1 prior chemotherapy regimen.<bold>Methods: </bold>Twenty-seven patients with advanced urothelial carcinoma were treated with sorafenib 400 mg orally twice daily continuously until progression or unacceptable toxicity.<bold>Results: </bold>There were no objective responses observed. The 4-month progression-free survival (PFS) rate was 9.5%; median overall survival of the group was 6.8 months. There were no therapy-related deaths, and common grade 3 toxicities included fatigue and hand-foot syndrome.<bold>Conclusions: </bold>Although sorafenib as a single agent has minimal activity in patients with advanced urothelial cancer in the second-line setting, further investigation of tyrosine kinase inhibitors using different trial designs with PFS endpoints is warranted.
- Publication
Cancer (0008543X), 2009, Vol 115, Issue 18, p4090
- ISSN
0008-543X
- Publication type
journal article
- DOI
10.1002/cncr.24467