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

S. Negrier, E. Jäger, C. Porta, D. McDermott, M. Moore, J. Bellmunt, S. Anderson, F. Cihon, J. Lewis, B. Escudier, R. Bukowski

Research output: Contribution to journalArticle

Abstract

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.

Original languageEnglish
Pages (from-to)899-906
Number of pages8
JournalMedical Oncology
Volume27
Issue number3
DOIs
Publication statusPublished - Sep 2010

Keywords

  • Cytokine
  • Interferon
  • Interleukin
  • Multikinase inhibitor
  • Renal cell cancer
  • Sorafenib
  • Subanalysis

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Hematology

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    Negrier, S., Jäger, E., Porta, C., McDermott, D., Moore, M., Bellmunt, J., Anderson, S., Cihon, F., Lewis, J., Escudier, B., & Bukowski, R. (2010). Efficacy and safety of sorafenib in patients with advanced renal cell carcinoma with and without prior cytokine therapy, a subanalysis of TARGET. Medical Oncology, 27(3), 899-906. https://doi.org/10.1007/s12032-009-9303-z