Original Paper

Medical Oncology

, Volume 27, Issue 3, pp 899-906

First online:

Efficacy and safety of sorafenib in patients with advanced renal cell carcinoma with and without prior cytokine therapy, a subanalysis of TARGET

  • S. NegrierAffiliated withCentre Leon Berard and Claude Bernard University Email author 
  • , E. JägerAffiliated withKrankenhaus Nordwest
  • , C. PortaAffiliated withIRCCS San Matteo University Hospital Foundation
  • , D. McDermottAffiliated withBeth Israel Deaconess Medical Center
  • , M. MooreAffiliated withPrincess Margaret Hospital
  • , J. BellmuntAffiliated withUniversity Hospital del Mar
  • , S. AndersonAffiliated withBayer Pharmaceuticals
  • , F. CihonAffiliated withBayer Pharmaceuticals
  • , J. LewisAffiliated withBayer Pharmaceuticals
    • , B. EscudierAffiliated withInstitut Gustave Roussy
    • , R. BukowskiAffiliated withCleveland Clinic Cancer Center

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Before the development of targeted therapies, administration of cytokines (e.g., interleukin-2, interferon-α) was the primary systemic treatment option for advanced renal cell carcinoma. Sorafenib, an oral targeted, multikinase inhibitor, significantly prolonged progression-free survival and overall survival in the Treatment Approaches in Renal Cancer Global Evaluation Trial (TARGET), a large (N = 903) phase III, double-blind, randomised, placebo-controlled study of patients with advanced renal cell carcinoma resistant to standard therapy. This analysis of a patient subgroup from TARGET evaluated the safety and efficacy of sorafenib in patients who had received prior cytokine therapy (sorafenib: n = 374; placebo: n = 368) and in patients who were cytokine-naïve (sorafenib: n = 77; placebo: n = 84). Progression-free survival was significantly prolonged with sorafenib therapy compared with placebo among patients with and without prior cytokine therapy (respectively 5.5 vs. 2.7 months; hazard ratio, 0.54; 95% confidence interval, 0.45–0.64 and 5.8 vs. 2.8 months; hazard ratio, 0.48; 95% confidence interval, 0.32–0.73). Clinical benefit rates for sorafenib-treated patients compared with placebo patients were also higher (cytokine-treated: 83 vs. 54.3%; cytokine-naïve: 85.7 vs. 56.0%). Sorafenib was well tolerated in both subgroups (grade 3/4: 20 and 22%, respectively). Sorafenib demonstrated a consistent, significant clinical benefit against advanced renal cell carcinoma, with a twofold improvement in progression-free survival and disease control rate, with similar toxicities in patients with or without prior cytokine treatment.


Sorafenib Cytokine Interferon Interleukin Renal cell cancer Multikinase inhibitor Subanalysis