Sorafenib, approved by the FDA in December 2005 is an angiogenesis inhibitor acting via inhibition of C-Raf, VEGF, PDGF-R, c-kit, and Flt-3.

A total of 903 patients with metastatic conventional renal cancer were randomized into treatment and placebo arms between 2003 and 2005. Although only 1 complete response was seen in the treatment arm, Nexavar was associated with improvements in disease stability (74% vs. 53% placebo) and disease progression (12% vs. 37% placebo). An interim analysis of progression-free survival showed a benefit in the Nexavar arm (median 24 weeks) compared with the placebo arm (12 weeks, p< 0.00001). The data, however, were not mature enough to note differences in disease specific survival. At the January 2005 cutoff, the median progression-free survival was 5.5 months in the sorafenib group and 2.8 months in the placebo group (hazard ratio = 0.44; 95% CI, 0.35 to 0.55; P less than 0.01).

The drug was relatively well tolerated with minor toxicities being rash (40% vs. 16%), diarrhea (43% vs. 13%), and hand-foot skin reaction (30% vs. 7%). Grade 3 toxicities were seen in less than 11% of patients taking Nexavar, although hypertension and cardiac ischemia were more common in the Nexavar arm.

Clearly in the last 2 years oncologists treating renal cancer have experienced an excess of riches compared with the limited efficacy of previous systemic therapies. We anxiously await a head-to-head comparison of these targeted therapies to determine which one should be used as first-line therapy.

Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, Negrier S, Chevreau C, Solska E, Desai AA, Rolland F, Demkow T, Hutson TE, Gore M, Freeman S, Schwartz B, Shan M, Simantov R, Bukowski RM

N Engl J Med; 356(2):125-34.

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Written by Ricardo Sånchez-Ortiz, MD, a Contributing Editor with UroToday.

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