JCO Early Release, published online ahead of print Jun 1 2009
Journal of Clinical Oncology, 10.1200/JCO.2008.20.1293
Received September 12, 2008
Accepted March 5, 2009
Overall Survival and Updated Results for Sunitinib Compared With Interferon Alfa in Patients With Metastatic Renal Cell Carcinoma
Robert J. Motzer,* Thomas E. Hutson, Piotr Tomczak, M. Dror Michaelson, Ronald M. Bukowski, Stéphane Oudard, Sylvie Negrier, Cezary Szczylik, Roberto Pili, Georg A. Bjarnason, Xavier Garcia-del-Muro, Jeffrey A. Sosman, Ewa Solska, George Wilding, John A. Thompson, Sindy T. Kim, Isan Chen, Xin Huang, and Robert A. Figlin
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.
* To whom correspondence should be addressed. 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.
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