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A potential treatment for a selected group of patients with metastatic renal cell carcinoma (RCC) is nephrectomy followed by surgery to remove metastases (radical metastasectomy). After surgery, patients are usually followed by observation or treated with anti-cancer drugs. The RESORT clinical trial assessed the potential benefit of treatment with sorafenib after radical metastasectomy compared with observation alone in patients with metastatic RCC.
Sixty-nine patients with clear cell metastatic RCC and who had undergone nephrectomy and radical metastasectomy were randomised to receive sorafenib or observation for 52 weeks. The primary endpoint was recurrence-free survival (RFS). Secondary endpoints were overall survival and the safety profile.
Median RFS was 37 months in the patients who were observed and 21 months in the patients on sorafenib. Adverse event rates were 84% in the sorafenib arm and 31% in the observation arm, with a rate of treatment discontinuation for AEs of 19% in the sorafenib arm.
In conclusion, this study showed that sorafenib treatment did not improve patient outcomes in terms of recurrence-free survival in patients with metastatic RCC following nephrectomy and radical metastasectomy.