Originally published as JCO Early Release 10.1200/JCO.2008.20.1293 on June 1 2009

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Overall Survival and Updated Results for Sunitinib Compared With Interferon Alfa in Patients With Metastatic Renal Cell Carcinoma

From the Memorial Sloan-Kettering Cancer Center, New York, NY; Baylor Sammons Cancer Center-Texas Oncology, PA, Dallas, TX; Massachusetts General Hospital Cancer Center, Boston, MA; Cleveland Clinic Taussig Cancer Center, Cleveland, OH; Johns Hopkins University, Baltimore, MD; Vanderbilt University, Nashville, TN; University of Wisconsin Paul P. Carbone Comprehensive Cancer Center, Madison, WI; Seattle Cancer Care Alliance, Seattle, WA; Pfizer Global Research and Development, La Jolla; City of Hope National Medical Center, Duarte, CA; Klinika Onkologii Oddzial Chemioterapii, Poznan; Military Institute of Medicine, Warsaw; Wojewodzka Przychodnia Onkolog, Gdansk, Poland; Hôpital Européen Georges-Pompidou, Paris; Centre Léon Bérard, Lyon, France; Sunnybrook Odette Cancer Centre, Toronto, Ontario, Canada; and Institut Catalá d'Oncologia, Barcelona, Spain.

Corresponding author: Robert J. Motzer, MD, Memorial Sloan-Kettering Cancer Center, 1275 York Ave, New York, NY 10021; e-mail: motzerr{at}mskcc.org.

Purpose A randomized, phase III trial demonstrated superiority of sunitinib over interferon alfa (IFN-) in progression-free survival (primary end point) as first-line treatment for metastatic renal cell carcinoma (RCC). Final survival analyses and updated results are reported.

Patients and Methods Seven hundred fifty treatment-naïve patients with metastatic clear cell RCC were randomly assigned to sunitinib 50 mg orally once daily on a 4 weeks on, 2 weeks off dosing schedule or to IFN- 9 MU subcutaneously thrice weekly. Overall survival was compared by two-sided log-rank and Wilcoxon tests. Progression-free survival, response, and safety end points were assessed with updated follow-up.

Results Median overall survival was greater in the sunitinib group than in the IFN- group (26.4 v 21.8 months, respectively; hazard ratio [HR] = 0.821; 95% CI, 0.673 to 1.001; P = .051) per the primary analysis of unstratified log-rank test (P = .013 per unstratified Wilcoxon test). By stratified log-rank test, the HR was 0.818 (95% CI, 0.669 to 0.999; P = .049). Within the IFN- group, 33% of patients received sunitinib, and 32% received other vascular endothelial growth factor–signaling inhibitors after discontinuation from the trial. Median progression-free survival was 11 months for sunitinib compared with 5 months for IFN- (P < .001). Objective response rate was 47% for sunitinib compared with 12% for IFN- (P < .001). The most commonly reported sunitinib-related grade 3 adverse events included hypertension (12%), fatigue (11%), diarrhea (9%), and hand-foot syndrome (9%).

Conclusion Sunitinib demonstrates longer overall survival compared with IFN- plus improvement in response and progression-free survival in the first-line treatment of patients with metastatic RCC. The overall survival highlights an improved prognosis in patients with RCC in the era of targeted therapy.

Supported by Pfizer, La Jolla, CA.

Presented in part at the 44th Annual Meeting of the American Society of Clinical Oncology, May 30-June 3, 2008, Chicago, IL.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

Clinical Trials repository link available on JCO.org.

Clinical trial information can be found for the following: NCT00083889 [ClinicalTrials.gov] .

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