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Phase 2 trial of sorafenib in patients with advanced urothelial cancer
Author(s) -
Dreicer Robert,
Li Hailun,
Stein Mark,
DiPaola Robert,
Eleff Michael,
Roth Bruce J.,
Wilding George
Publication year - 2009
Publication title -
cancer
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 3.052
H-Index - 304
eISSN - 1097-0142
pISSN - 0008-543X
DOI - 10.1002/cncr.24467
Subject(s) - medicine , sorafenib , oncology , chemotherapy , regimen , toxicity , cancer , progression free survival , cisplatin , clinical trial , urothelial cancer , surgery , bladder cancer , hepatocellular carcinoma
BACKGROUND: 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. METHODS: Twenty‐seven patients with advanced urothelial carcinoma were treated with sorafenib 400 mg orally twice daily continuously until progression or unacceptable toxicity. RESULTS: 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. CONCLUSIONS: 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. Cancer 2009. © 2009 American Cancer Society.