Pazopanib versus Sunitinib in metastatic renal-cell carcinoma

Motzer, R.J. et al. (2013) Pazopanib versus Sunitinib in metastatic renal-cell carcinoma. New England Journal of Medicine, 369(8), pp. 722-731. (doi: 10.1056/NEJMoa1303989)

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Publisher's URL: http://dx.doi.org/10.1056/NEJMoa1303989

Abstract

BACKGROUND: Pazopanib and sunitinib provided a progression-free survival benefit, as compared with placebo or interferon, in previous phase 3 studies involving patients with metastatic renal-cell carcinoma. This phase 3, randomized trial compared the efficacy and safety of pazopanib and sunitinib as first-line therapy. METHODS: We randomly assigned 1110 patients with clear-cell, metastatic renal-cell carcinoma, in a 1:1 ratio, to receive a continuous dose of pazopanib (800 mg once daily; 557 patients) or sunitinib in 6-week cycles (50 mg once daily for 4 weeks, followed by 2 weeks without treatment; 553 patients). The primary end point was progression-free survival as assessed by independent review, and the study was powered to show the noninferiority of pazopanib versus sunitinib. Secondary end points included overall survival, safety, and quality of life. RESULTS: Pazopanib was noninferior to sunitinib with respect to progression-free survival (hazard ratio for progression of disease or death from any cause, 1.05; 95% confidence interval [CI], 0.90 to 1.22), meeting the predefined noninferiority margin (upper bound of the 95% confidence interval, <1.25). Overall survival was similar (hazard ratio for death with pazopanib, 0.91; 95% CI, 0.76 to 1.08). Patients treated with sunitinib, as compared with those treated with pazopanib, had a higher incidence of fatigue (63% vs. 55%), the hand–foot syndrome (50% vs. 29%), and thrombocytopenia (78% vs. 41%); patients treated with pazopanib had a higher incidence of increased levels of alanine aminotransferase (60%, vs. 43% with sunitinib). The mean change from baseline in 11 of 14 health-related quality-of-life domains, particularly those related to fatigue or soreness in the mouth, throat, hands, or feet, during the first 6 months of treatment favored pazopanib (P<0.05 for all 11 comparisons)

Item Type:Articles
Status:Published
Refereed:Yes
Glasgow Author(s) Enlighten ID:Jones, Professor Robert
Authors: Motzer, R.J., Hutson, T.E., Cella, D., Reeves, J., Hawkins, R., Guo, J., Nathan, P., Staehler, M., de Souza, P., Merchan, J.R., Boleti, E., Fife, K., Jin, J., Jones, R., Uemura, H., De Giorgi, U., Harmenberg, U., Wang, J., Sternberg, C.N., Deen, K., McCann, L., Hackshaw, M.D., Crescenzo, R., Pandite, L.N., and Choueiri, T.K.
College/School:College of Medical Veterinary and Life Sciences > Institute of Cancer Sciences
Journal Name:New England Journal of Medicine
Publisher:Massachusetts Medical Society
ISSN:0028-4793
ISSN (Online):1533-4406

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