Sorafenib in advanced clear-cell renal-cell carcinoma.

摘要: Background We conducted a phase 3, randomized, double-blind, placebo-controlled trial of sorafenib, multikinase inhibitor tumor-cell proliferation and angiogenesis, in patients with advanced clear-cell renal-cell carcinoma. Methods From November 2003 to March 2005, we randomly assigned 903 carcinoma that was resistant standard therapy receive either continuous treatment oral sorafenib (at dose 400 mg twice daily) or placebo; 451 received 452 placebo. The primary end point overall survival. A single planned analysis progression-free survival January 2005 showed statistically significant benefit over Consequently, crossover permitted from placebo beginning May 2005. Results At the cutoff, median 5.5 months group 2.8 (hazard ratio for disease progression group, 0.44;...