The Absolute Effect / Evidence / CARMENA
Renal Cell Carcinoma · Surgical Oncology · Metastatic Disease
CARMENA
Clinical question
In intermediate/poor-risk metastatic RCC, is upfront cytoreductive nephrectomy necessary before systemic therapy?
Trial context
Population
450 patients with metastatic clear-cell RCC, MSKCC intermediate or poor risk
Intervention
Sunitinib alone vs cytoreductive nephrectomy followed by sunitinib
Key endpoint
Overall survival
Time horizon / follow-up
Median follow-up 50.9 months
Absolute Effect
What changes for patients?
Sunitinib alone was non-inferior to nephrectomy followed by sunitinib for OS; median OS was 18.4 vs 13.9 months. The upper 95% CI of the HR remained below the prespecified NI margin of 1.20. This is a non-inferiority result, not proof that surgery is harmful or never useful.
NNT: Not applicable; non-inferiority trial
Treatment burden / harm
Major surgery burden
NNH: Not quantifiable from the primary endpoint
Relative effect
NON-INFERIOR; HR: 0.89
95% CI 0.71–1.10; NI margin 1.20
Clinical interpretation
CARMENA argues against routine upfront cytoreductive nephrectomy for all intermediate/poor-risk metastatic RCC patients who need systemic therapy.
Primary publication
- Méjean A, et al. N Engl J Med. 2018;379:417–427.
- Méjean A, et al. Eur Urol. 2021;80:417–424.
- Primary publication / source
- Primary publication / source