Comment in:

Eur Urol. 2007 May;51(5):1444.

N Engl J Med. 2007 Apr 12;356(15):1580; author reply 1580-1.

N Engl J Med. 2007 Jan 11;356(2):184-5.

N Engl J Med. 2007 Jan 11;356(2):185-7.

N Engl J Med. 2007 Sep 6;357(10):1050; author reply 1050-1.

Nat Clin Pract Oncol. 2007 Aug;4(8):458-9.

Nat Clin Pract Urol. 2007 Sep;4(9):470-1.

Sunitinib versus interferon alfa in metastatic renal-cell carcinoma.

Memorial Sloan-Kettering Cancer Center, New York, NY 10021, USA. motzerr@mskcc.org

BACKGROUND: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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 (ClinicalTrials.gov numbers, NCT00098657 and NCT00083889 [ClinicalTrials.gov]). Copyright 2007 Massachusetts Medical Society.

PMID: 17215529 [PubMed - indexed for MEDLINE]