Phase 2 trial of sorafenib in patients with advanced urothelial cancer: A Trial of the Eastern Cooperative Oncology Group

Robert Dreicer, Hailun Li, Mark Stein, Robert DiPaola, Michael Eleff, Bruce J. Roth, George Wilding

Research output: Contribution to journalArticlepeer-review

129 Scopus citations

Abstract

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.

Original languageEnglish
Pages (from-to)4090-4095
Number of pages6
JournalCancer
Volume115
Issue number18
DOIs
StatePublished - Sep 15 2009

Keywords

  • Cisplatin
  • Sorafenib
  • Tyrosine kinase inhibitors
  • Urothelial cancer

Fingerprint

Dive into the research topics of 'Phase 2 trial of sorafenib in patients with advanced urothelial cancer: A Trial of the Eastern Cooperative Oncology Group'. Together they form a unique fingerprint.

Cite this