Combination therapy with S-1 plus sorafenib is effective and tolerable as treatment for patients with metastatic renal cell carcinoma, a new study published online ahead of print in the journal Annals of Oncology has shown.

For the single-arm, open-label, phase 1/2 study, researchers sought to evaluate the clinical activity, safety, tolerance, and pharmacokinetics of S-1 plus sorafenib in patients with metastatic renal cell carcinoma.

Researchers enrolled nine patients into phase 1 and 21 patients into phase 2. Of those 21, six had received the recommended dose in phase 1. All participants were diagnosed with clear-cell or papillary renal cell carcinoma who had received no more than one prior cytokine-based regimen.

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The recommended dose of therapy was S-1 80 mg/m2/day on days 1 to 28 with sorafenib 800 mg/day on days 1 to 42.

Results showed that among the 21 evaluable patients in phase 2, the confirmed overall response rate was 52% (95% CI: 29.8, 74.3). One patient achieved a complete response and 10 patients achieved partial responses.

Researchers found that median progression-free survival was 9.9 months (95% CI: 6.5, 17.1).

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In regard to safety, all patients experienced treatment-related hand-foot skin reactions, which resulted in dose reductions in 38% of patients.

The findings suggest that although S-1 and sorafenib combination therapy appears to be effective and tolerable for patients with metastatic renal cell carcinoma, skin event management is necessary for patients receiving this therapy.


  1. Naito S, Sakai H, Hashine K, et al. Phase 1/2 study of S-1 in combination with sorafenib for metastatic renal cell carcinoma.Ann Oncol. 2015. [epub ahead of print]. doi: 10.1093/annonc/mdv280.