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, Robert A. Figlin

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1718 Scopus citations

Abstract

Purpose: A randomized, phase III trial demonstrated superiority of sunitinib over interferon alfa (IFN-α) 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-α 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-α 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-α 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-α (P < .001). Objective response rate was 47% for sunitinib compared with 12% for IFN-α (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-α 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.

Original languageEnglish (US)
Pages (from-to)3584-3590
Number of pages7
JournalJournal of Clinical Oncology
Volume27
Issue number22
DOIs
StatePublished - Aug 1 2009

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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    Motzer, R. J., Hutson, T. E., Tomczak, P., Michaelson, M. D., Bukowski, R. M., Oudard, S., Negrier, S., Szczylik, C., Pili, R., Bjarnason, G. A., Garcia-del-Muro, X., Sosman, J. A., Solska, E., Wilding, G., Thompson, J. A., Kim, S. T., Chen, I., Huang, X., & Figlin, R. A. (2009). Overall survival and updated results for sunitinib compared with interferon alfa in patients with metastatic renal cell carcinoma. Journal of Clinical Oncology, 27(22), 3584-3590. https://doi.org/10.1200/JCO.2008.20.1293