Since sunitinib malate has shown activity in two uncontrolled studies in patients with metastatic renal-cell carcinoma, a comparison of the drug with interferon alfa in a phase 3 trial is warranted.

We enrolled 750 patients with previously untreated, metastatic renal-cell carcinoma in a multicenter, randomized, phase 3 trial to receive either repeated 6-week cycles of sunitinib (at a dose of 50 mg given orally once daily for 4 weeks, followed by 2 weeks without treatment) or interferon alfa (at a dose of 9 MU given subcutaneously three times weekly). The primary end point was progression-free survival. Secondary end points included the objective response rate, overall survival, patient-reported outcomes, and safety.

The median progression-free survival was significantly longer in the sunitinib group ( 11 months ) than in the interferon alfa group ( 5 months ), corresponding to a hazard ratio of 0.42 ( 95% confidence interval, 0.32 to 0.54; P<0.001 ). Sunitinib was also associated with a higher objective response rate than was interferon alfa ( 31% vs. 6%, P<0.001 ). The proportion of patients with grade 3 or 4 treatment-related fatigue was significantly higher in the group treated with interferon alfa, whereas diarrhea was more frequent in the sunitinib group ( P<0.05 ). Patients in the sunitinib group reported a significantly better quality of life than did patients in the interferon alfa group ( P<0.001 ).

Progression-free survival was longer and response rates were higher in patients with metastatic renal-cell cancer who received sunitinib than in those receiving interferon alfa
Source: N Engl J Med, 2007; 356: 115-124

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