Sunitinib Alone or after Nephrectomy in Metastatic Renal‑Cell Carcinoma
Sunitinib alone is not inferior to nephrectomy followed by sunitinib in patients with metastatic renal‑cell carcinoma who are classified as having intermediate‑risk or poor‑risk disease.
In a phase‑3 randomized controlled trial (CARMENA), 450 patients with metastatic clear‑cell renal‑cell carcinoma (intermediate or poor risk) were assigned to either nephrectomy followed by sunitinib or sunitinib alone. The primary endpoint was overall survival. Interim analysis showed that overall survival with sunitinib alone (median 18.4 months) was not inferior to that with nephrectomy plus sunitinib (median 13.9 months) (hazard ratio 0.89; 95% CI 0.71‑1.10; non‑inferiority margin 1.20). No significant differences were observed in response rate, progression‑free survival, or adverse events.
This study challenges the traditional paradigm that cytoreductive nephrectomy is essential before systemic therapy in metastatic renal‑cell carcinoma. By demonstrating non‑inferiority of sunitinib alone, it offers a less invasive treatment option that may reduce operative morbidity and allow earlier systemic therapy initiation for patients with intermediate‑ or poor‑risk disease.
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