TY - JOUR
T1 - Pazopanib versus sunitinib in metastatic renal-cell carcinoma
AU - Motzer, Robert J.
AU - Hutson, Thomas E.
AU - Cella, David
AU - Reeves, James
AU - Hawkins, Robert
AU - Guo, Jun
AU - Nathan, Paul
AU - Staehler, Michael
AU - Souza, Paulde
AU - Merchan, Jaime R.
AU - Boleti, Ekaterini
AU - Fife, Kate
AU - Jin, Jie
AU - Jones, Robert
AU - Uemura, Hirotsugu
AU - De Giorgi, Ugo
AU - Harmenberg, Ulrika
AU - Wang, Jinwan
AU - Sternberg, Cora N.
AU - Deen, Keith
AU - McCann, Lauren
AU - Hackshaw, Michelle D.
AU - Crescenzo, Rocco
AU - Pandite, Lini N.
AU - Choueiri, Toni K.
PY - 2013
Y1 - 2013
N2 - 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,
AB - 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,
U2 - 10.1056/NEJMoa1303989
DO - 10.1056/NEJMoa1303989
M3 - Article
SN - 1533-4406
VL - 369
SP - 722
EP - 731
JO - New England Journal Of Medicine
JF - New England Journal Of Medicine
IS - 8
ER -
