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

被引:1848
作者
Motzer, Robert J. [1 ]
Hutson, Thomas E.
Tomczak, Piotr
Michaelson, M. Dror
Bukowski, Ronald M.
Oudard, Stephane
Negrier, Sylvie
Szczylik, Cezary
Pili, Roberto
Bjarnason, Georg A.
Garcia-del-Muro, Xavier
Sosman, Jeffrey A.
Solska, Ewa
Wilding, George
Thompson, John A.
Kim, Sindy T.
Chen, Isan
Huang, Xin
Figlin, Robert A.
机构
[1] Mem Sloan Kettering Canc Ctr, New York, NY 10021 USA
关键词
HYPOTHYROIDISM; EFFICACY; TUMORS;
D O I
10.1200/JCO.2008.20.1293
中图分类号
R73 [肿瘤学];
学科分类号
100214 ;
摘要
Purpose A randomized, phase III trial demonstrated superiority of sunitinib over interferon alfa (IFN-alpha) 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-nave 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-alpha 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-alpha 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-alpha 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-alpha (P < .001). Objective response rate was 47% for sunitinib compared with 12% for IFN-alpha (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-alpha 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. J Clin Oncol 27: 3584-3590. (C) 2009 by American Society of Clinical Oncology
引用
收藏
页码:3584 / 3590
页数:7
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