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← Renal Cell Cancer

HEALTH PROFESSIONAL · SOURCE READING

Sorafenib

Source: Renal Cell Cancer Treatment (PDQ®)–Health Professional Version, National Cancer Institute.

Source updated: May 13, 2025 · Captured 2026-09-09.

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Context: Treatment of Stage IV and Recurrent Renal Cell Cancer / Antiangiogenic and Other Targeted Therapy / Anti-vascular endothelial growth factor (VEGF) and multitargeted tyrosine kinase inhibitors (TKIs)

Sorafenib is an orally available multikinase inhibitor (CRAF, BRAF, KIT, FLT-3, VEGFR-2, VEGFR-3, and PDGFRB) and has also been approved for the treatment of patients with advanced renal cell carcinoma.[58]

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Evidence (sorafenib):

In an international, multicenter, randomized trial, 769 patients were stratified by the Memorial Sloan Kettering Cancer Center prognostic risk category and by country. Patients were randomly assigned to receive either sorafenib (400 mg bid) or a placebo. Approximately 82% of the patients had received IL-2 previously and/or interferon alfa in both arms of the study. The primary end points were PFS and OS.

In an international, multicenter, randomized trial, 769 patients were stratified by the Memorial Sloan Kettering Cancer Center prognostic risk category and by country. Patients were randomly assigned to receive either sorafenib (400 mg bid) or a placebo. Approximately 82% of the patients had received IL-2 previously and/or interferon alfa in both arms of the study. The primary end points were PFS and OS.

The median PFS for patients randomly assigned to sorafenib was 167 days compared with 84 days for patients randomly assigned to placebo (P < .001).

In an international, multicenter, randomized trial, 769 patients were stratified by the Memorial Sloan Kettering Cancer Center prognostic risk category and by country. Patients were randomly assigned to receive either sorafenib (400 mg bid) or a placebo. Approximately 82% of the patients had received IL-2 previously and/or interferon alfa in both arms of the study. The primary end points were PFS and OS.

The estimated HR for the risk of progression with sorafenib compared with a placebo was 0.44 (95% CI, 0.35–0.55). There was no significant difference in OS.[58][Level of evidence B1]

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A phase II study randomly assigned 189 patients to either sorafenib or interferon alfa.[29]

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A phase II study randomly assigned 189 patients to either sorafenib or interferon alfa.[29]

No difference was reported in PFS (5.7 months vs. 5.6 months), but sorafenib was associated with better QOL than interferon alfa.

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Preserved source evidence · Not medical advice