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.
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.