TY - JOUR
AU1 - Motzer, Robert J.
AU2 - Hutson, Thomas E.
AU3 - Cella, David
AU4 - Reeves, James
AU5 - Hawkins, Robert
AU6 - Guo, Jun
AU7 - Nathan, Paul
AU8 - Staehler, Michael
AU9 - de Souza, Paul
AU1 - Merchan, Jaime R.
AU1 - Boleti, Ekaterini
AU1 - Fife, Kate
AU1 - Jin, Jie
AU1 - Jones, Robert
AU1 - Uemura, Hirotsugu
AU1 - De Giorgi, Ugo
AU1 - Harmenberg, Ulrika
AU1 - Wang, Jinwan
AU1 - Sternberg, Cora N.
AU2 - Deen, Keith
AU2 - McCann, Lauren
AU2 - Hackshaw, Michelle D.
AU2 - Crescenzo, Rocco
AU2 - Pandite, Lini N.
AU2 - Choueiri, Toni K.
AB - BackgroundPazopanib 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.MethodsWe 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.ResultsPazopanib 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).ConclusionsPazopanib and sunitinib have similar efficacy, but the safety and quality-of-life profiles favor pazopanib. (Funded by GlaxoSmithKline Pharmaceuticals; COMPARZ ClinicalTrials.gov number, NCT00720941.)
TI - Pazopanib versus Sunitinib in Metastatic Renal-Cell Carcinoma
JF - The New England Journal of Medicine
DO - 10.1056/NEJMoa1303989
DA - 2013-08-22
UR - https://www.deepdyve.com/lp/the-new-england-journal-of-medicine/pazopanib-versus-sunitinib-in-metastatic-renal-cell-carcinoma-kOxb0aGvqo
SP - 722
EP - 731
VL - 369
IS - 8
DP - DeepDyve
ER -