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

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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

Fingerprint

Kidney Neoplasms
Renal Cell Carcinoma
Cytokines
Safety
Placebos
Disease-Free Survival
Therapeutics
Confidence Intervals
sorafenib
Interferons
Interleukin-2
Survival

Keywords

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

ASJC Scopus subject areas

  • Oncology
  • Cancer Research
  • Hematology

Cite this

Efficacy and safety of sorafenib in patients with advanced renal cell carcinoma with and without prior cytokine therapy, a subanalysis of TARGET. / Negrier, S.; Jäger, E.; Porta, C.; McDermott, D.; Moore, M.; Bellmunt, J.; Anderson, S.; Cihon, F.; Lewis, J.; Escudier, B.; Bukowski, R.

In: Medical Oncology, Vol. 27, No. 3, 09.2010, p. 899-906.

Research output: Contribution to journalArticle

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, vol. 27, no. 3, pp. 899-906. https://doi.org/10.1007/s12032-009-9303-z
Negrier, S. ; Jäger, E. ; Porta, C. ; McDermott, D. ; Moore, M. ; Bellmunt, J. ; Anderson, S. ; Cihon, F. ; Lewis, J. ; Escudier, B. ; Bukowski, R. / Efficacy and safety of sorafenib in patients with advanced renal cell carcinoma with and without prior cytokine therapy, a subanalysis of TARGET. In: Medical Oncology. 2010 ; Vol. 27, No. 3. pp. 899-906.
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