Patient Summary: Phase III randomized trial of sunitinib malate (SU11248) versus interferon-alpha (IFN-alpha) as first-line systemic therapy for patients with metastatic renal cell carcinoma (mRCC)
Phase III randomized trial of sunitinib malate (SU11248) versus interferon-alpha (IFN-alpha) as first-line systemic therapy for patients with metastatic renal cell carcinoma (mRCC).
This study looked at one of the recently approved drugs for renal cell carcinoma, Sutent (sunitinib malate), and compared it to standard therapy with interferon-alpha (IFN). Seven-hundred and fifty patients who had no prior medical therapy were randomized to receive either IFN (3 million units s.q. three times weekly x 1 wk, that was dose escalated to 6 MU x 1 wk, then 9 MU) or sunitinib (50 mg daily for 4 wks, then 2 wks off, then repeat cycles).
Median progression-free survival was significantly better in the Sutent arm: 47.3 weeks versus 24.9 weeks in IFN arm (p<.000001). It is important to understand that the median is not the average. Median is that time point at which half of the patients had progression and half did not. This drug was well tolerated. The review did not mention side effects, but these have been previously reported as: fatigue, myelosuppresion (low white blood cell counts) and gastrointestinal upset (diarrhea, nausea, and vomiting).
This study shows the role of Sutent in first line therapy for renal cell carcinoma. Look for updates to this trial in coming years to see longer follow up periods.