The Absolute Effect / Evidence / S-TRAC
Renal Cell Carcinoma · Medical Oncology · Adjuvant
S-TRAC
Clinical question
Does adjuvant sunitinib improve disease-free survival after nephrectomy in high-risk clear-cell RCC?
Trial context
Population
615 patients with high-risk clear-cell RCC after nephrectomy
Intervention
Adjuvant sunitinib vs placebo after nephrectomy
Key endpoint
5-year disease-free survival
Time horizon / follow-up
5 years
Absolute Effect
What changes for patients?
At 5 years, disease-free survival was 59.3% with sunitinib versus 51.3% with placebo, an absolute benefit of 8 percentage points (NNT 13). Median DFS was 6.8 vs 5.6 years. The DFS benefit came with substantial toxicity and treatment discontinuation.
NNT: 13
Treatment burden / harm
Grade 3 treatment-emergent adverse events
NNH: 4
Relative effect
HR: 0.76
95% CI 0.59–0.98; P=.03
Clinical interpretation
S-TRAC showed a disease-free-survival benefit for adjuvant sunitinib without an established overall-survival gain and with substantial toxicity, limiting its routine role.
Primary publication
- Ravaud A, et al. N Engl J Med. 2016;375:2246–2254.
- Primary publication / source