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Bending the Curve Trial by Trial
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S-TRAC

Adjuvant sunitinib in high-risk renal-cell carcinoma after nephrectomy (S-TRAC)

Phase 3N = 615NCT00375674

Population
Locoregional, high-risk clear-cell renal-cell carcinoma after nephrectomy.
Design
Randomised, double-blind phase 3 trial. Sunitinib 50 mg per day or placebo on a 4-weeks-on, 2-weeks-off schedule for 1 year or until recurrence, unacceptable toxicity or withdrawal of consent. The ClinicalTrials.gov record lists enrolment of 674; the abstract reports 615 patients.
Primary endpoint
DFS
Arms
  • Sunitinib (experimental): Sunitinib 50 mg per day, 4 weeks on and 2 weeks off, for 1 year
  • Placebo (control): Placebo on the same schedule
People
Ravaud A
DFSHR 0.76 (95% CI 0.59–0.98)Δ median DFS+1.2 years
Show the numbers
Results reported for S-TRAC
EndpointAnalysisSunitinibPlaceboEffect
DFSRandomised patients (analysis population not stated in the abstract)Disease-free survival by blinded independent central review.primaryRavaud 2016median 6.8 yearsmedian 5.6 years (3.8–6.6)HR 0.76 (95% CI 0.59–0.98)P=0.03The 95% confidence interval for the sunitinib median was 5.8 years to not reached. Overall survival data were not mature at the cutoff. Dose reductions for adverse events occurred in 34.3% (sunitinib) vs 2% (placebo), dose interruptions in 46.4% vs 13.2% and discontinuations in 28.1% vs 5.6%. Grade 3 events 48.4% and grade 4 events 12.1% with sunitinib vs 15.8% and 3.6% with placebo.
Results reported for S-TRAC
EndpointAnalysisSunitinibPlaceboEffect
DFSRandomised patients (analysis population not stated in the abstract)Disease-free survival by blinded independent central review.primaryRavaud 2016median 6.8 yearsmedian 5.6 years (3.8–6.6)HR 0.76 (95% CI 0.59–0.98)P=0.03The 95% confidence interval for the sunitinib median was 5.8 years to not reached. Overall survival data were not mature at the cutoff. Dose reductions for adverse events occurred in 34.3% (sunitinib) vs 2% (placebo), dose interruptions in 46.4% vs 13.2% and discontinuations in 28.1% vs 5.6%. Grade 3 events 48.4% and grade 4 events 12.1% with sunitinib vs 15.8% and 3.6% with placebo.
Hazard ratio (95% CI) by endpoint. Values below 1 favour the experimental arm.
DFS0.512◀ experimentalcontrol ▶
Data table
EndpointHR95% CI
DFS0.760.59–0.98
Illustrative — modelled from reported values, not trial data. DFS, primary.
0%25%50%75%100%050100150200Months (modelled)
  • Sunitinib (experimental)
  • Placebo (control)

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

Data table (modelled values)
MonthsSunitinibPlacebo
0100.0%100.0%
5164.8%59.1%
10242.0%34.9%
15327.3%20.6%
20417.7%12.2%
Primary publication: Ravaud A, Motzer RJ, Pandha HS, George DJ, Pantuck AJ, Patel A, et al. Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy. N Engl J Med. 2016;375(23):2246-2254. PubMedDOI

Appears in

Sources

  1. Ravaud A, Motzer RJ, Pandha HS, George DJ, Pantuck AJ, Patel A, et al. Adjuvant Sunitinib in High-Risk Renal-Cell Carcinoma after Nephrectomy. N Engl J Med. 2016;375(23):2246-2254.

    PubMedDOI