Safety and tolerability of sorafenib in clear-cell renal cell carcinoma: a Phase III overview.
This review summarizes the safety of sorafenib, an oral multikinase inhibitor, focusing on the randomized, placebo-controlled, Phase III Treatment Approaches in Renal Cancer Global Evaluation Trial (TARGET) in renal cell carcinoma, which formed the basis of the approval of sorafenib. Similar to other targeted agents, sorafenib acts primarily to induce disease stabilization, rather than tumor regression, suggesting that long-term administration is necessary. The tolerability of an agent is important in long-term treatment, and a predictable and manageable side-effect profile is advantageous. Although IL-2 and interferon have been standard care treatments for advanced renal cell carcinoma for over a decade, they are poorly tolerated. Targeted agents offer an alternative for patients with advanced renal cell carcinoma, as initial therapy or after failure of cytokine treatment.
Hutson
Thomas E
TE
Baylor University Medical Center, GU Oncology Program, Texas Oncology, PA, Sammons Cancer Center, 3535 Worth Street, Dallas TX 75246, USA. thomas.hutson@usoncology.com
D001557:Benzenesulfonates / Q000009:adverse effects* / Q000627:therapeutic use*; D002292:Carcinoma, Renal Cell / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D017326:Clinical Trials, Phase III as Topic / Q000379:methods*; D006801:Humans; D007680:Kidney Neoplasms / Q000188:drug therapy* / Q000453:epidemiology / Q000503:physiopathology; D009536:Niacinamide / Q000031:analogs & derivatives; D010671:Phenylurea Compounds; D011725:Pyridines / Q000009:adverse effects* / Q000627:therapeutic use*; D000077157:Sorafenib
D001557:Benzenesulfonates; D010671:Phenylurea Compounds; D011725:Pyridines; D009536:Niacinamide; D000077157:Sorafenib