Sunitinib versus interferon alfa in metastatic renal-cell carcinoma Journal Article
| Authors: | Motzer, R. J.; Hutson, T. E.; Tomczak, P.; Michaelson, D.; Bukowski, R. M.; Rixe, O.; Oudard, S.; Negrier, S.; Szczylik, C.; Kim, S. T.; Chen, I.; Bycott, P. W.; Baum, C. M.; Figlin, R. A. |
| Article Title: | Sunitinib versus interferon alfa in metastatic renal-cell carcinoma |
| Abstract: | 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. Copyright © 2007 Massachusetts Medical Society. |
| Keywords: | adult; cancer survival; controlled study; aged; aged, 80 and over; middle aged; major clinical study; clinical trial; fatigue; neutropenia; sunitinib; cancer growth; cancer risk; diarrhea; drug dose reduction; drug efficacy; hypertension; hypophosphatemia; side effect; receptors, vascular endothelial growth factor; alpha interferon; quality of life; controlled clinical trial; anemia; leukopenia; mucosa inflammation; nausea; randomized controlled trial; stomatitis; thrombocytopenia; vomiting; myalgia; risk factors; creatinine blood level; kidney carcinoma; kidney neoplasms; alanine aminotransferase blood level; aspartate aminotransferase blood level; asthenia; chill; fever; lymphocytopenia; rash; protein kinase inhibitors; kaplan-meiers estimate; hair color; carcinoma, renal cell; disease progression; multicenter study; xerostomia; limb pain; skin discoloration; alkaline phosphatase blood level; flu like syndrome; headache; phase 3 clinical trial; indoles; pyrroles; amylase blood level; hand foot syndrome; triacylglycerol lipase blood level; dry skin; angiogenesis inhibitors; epistaxis; bilirubin blood level; uric acid blood level; receptors, platelet-derived growth factor; interferon-alpha; recombinant alpha2a interferon; heart ejection fraction |
| Journal Title: | New England Journal of Medicine |
| Volume: | 356 |
| Issue: | 2 |
| ISSN: | 0028-4793 |
| Publisher: | Massachusetts Medical Society |
| Date Published: | 2007-01-11 |
| Start Page: | 115 |
| End Page: | 124 |
| Language: | English |
| DOI: | 10.1056/NEJMoa065044 |
| PUBMED: | 17215529 |
| PROVIDER: | scopus |
| DOI/URL: | |
| Notes: | --- - "Cited By (since 1996): 1694" - "Export Date: 17 November 2011" - "CODEN: NEJMA" - "Source: Scopus" |
