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TARGET

Study of BAY43-9006 in Patients With Unresectable and/or Metastatic Renal Cell Cancer

Phase 3N = 903NCT00073307

Population
Advanced clear-cell renal cell carcinoma resistant to standard therapy
Design
Randomised, double-blind, placebo-controlled phase 3 trial of sorafenib 400 mg twice daily versus placebo, November 2003 to March 2005. Primary end point overall survival. A single planned analysis of progression-free survival in January 2005 showed a statistically significant benefit, after which crossover from placebo to sorafenib was permitted from May 2005.
Primary endpoint
OS
Arms
  • Sorafenib (experimental, n = 451): Sorafenib 400 mg orally twice daily, continuous
  • Placebo (control, n = 452): Placebo
People
Escudier B, TARGET Study Group
PFSHR 0.44 (95% CI 0.35–0.55)Δ median PFS+2.7 monthsOSHR 0.72 (95% CI 0.54–0.94)
Show the numbers
Results reported for TARGET
EndpointAnalysisSorafenibPlaceboEffect
PFSRandomised patients at the January 2005 cutoff (analysis population not stated in the abstract)primaryEscudier 2007median 5.5 monthsmedian 2.8 monthsHR 0.44 (95% CI 0.35–0.55)P<0.01Single planned analysis of progression-free survival at the January 2005 cutoff.
OSRandomised patients at the first interim analysis, May 2005 (analysis population not stated in the abstract)interimEscudier 2007——HR 0.72 (95% CI 0.54–0.94)P=0.02First interim analysis of overall survival in May 2005; the abstract states the benefit was not statistically significant according to the O'Brien-Fleming threshold. Crossover from placebo was permitted from May 2005.
Results reported for TARGET
EndpointAnalysisSorafenibPlaceboEffect
PFSRandomised patients at the January 2005 cutoff (analysis population not stated in the abstract)primaryEscudier 2007median 5.5 monthsmedian 2.8 monthsHR 0.44 (95% CI 0.35–0.55)P<0.01Single planned analysis of progression-free survival at the January 2005 cutoff.
OSRandomised patients at the first interim analysis, May 2005 (analysis population not stated in the abstract)interimEscudier 2007——HR 0.72 (95% CI 0.54–0.94)P=0.02First interim analysis of overall survival in May 2005; the abstract states the benefit was not statistically significant according to the O'Brien-Fleming threshold. Crossover from placebo was permitted from May 2005.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
PFSOS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
PFS0.440.35–0.55
OS0.720.54–0.94
Illustrative — modelled from reported values, not trial data. PFS, primary.
0%25%50%75%100%024681012Months (modelled)
  • Sorafenib (experimental)
  • Placebo (control)

Median-only curves assume a constant hazard (exponential) and fit plateaus, as seen with some immunotherapies, poorly.

Data table (modelled values)
MonthsSorafenibPlacebo
0100.0%100.0%
368.5%47.6%
741.4%17.7%
1028.4%8.4%
1417.1%3.1%
Primary publication: Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007;356(2):125-34. PubMedDOI

Appears in

Sources

  1. Escudier B, Eisen T, Stadler WM, Szczylik C, Oudard S, Siebels M, et al. Sorafenib in advanced clear-cell renal-cell carcinoma. N Engl J Med. 2007;356(2):125-34.

    PubMedDOI