The primary endpoint was progression-free survival. A total of 89 patients were evaluable. There were 49 patients receiving gem/cis plus placebo (arm A, mean age 67 years) and 40 patients (arm B, mean age 64 years) receiving gem/cis plus sorafenib. Patients in arm A had local recurrence or positive lymph nodes or additional organ metastases with or without lymph node metastases in 6%, 47% and 47% compared to 12.5%, 30% and 57.5% in arm B. There were 6 complete responses (CRs), 14 partial responses (PRs), 14 stable diseases (SDs) and 9 progressive diseases (PDs) in arm A compared to 5 CRs, 16 PRs, 9 SDs and 10 PDs in arm B. Grade 3-5 toxicity rates were also comparable between both treatment arms. The authors concluded that sorafenib did not relevantly increased toxicity but also did not alter outcome in terms of progression-free and overall survival.
Sorafenib has its role in the treatment of metastatic kidney cancer. However, the vascular endothelial growth factor (VEGF) pathway and its therapeutic “manipulation” do obviously not play the same role in urothelial cancer. In another phase-II trail that was published in 2011, there was also no benefit obtained from the additional use of sorafenib in patients with metastatic urothelial cancer. Probably, phase-III trials are not justified using this drug in urothelial cancer.
Presented by S. Krege et al. at the Deutsche Gesellschaft für Urologie (DGU) - 63rd Annual Congress - September 14 - 17, 2011 - Congress Center - Hamburg, Germany
Reported for UroToday by Christian Doehn, MD, PhD, Urologikum Lubeck, Lubeck, Germany.
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