A Head-to-Head Comparison of Pazopanib Versus Sunitinib in the First-Line Treatment of Patients with Metastatic Renal Cell Carcinoma
Pazopanib and sunitinib have similar efficacy, but the safety and quality of life profiles favour pazopanib
The randomised, open label, phase III COMPARZ (Comparing the Efficacy, Safety, and Tolerability of Pazopanib vs. Sunitinib) trial was a head-to-head comparison of the efficacy, safety and tolerability of pazopanib versus sunitinib in treatment-naive patients with clear cell metastatic renal cell carcinoma (mRCC) with measurable disease. The results were presented in part at the ESMO 2012 Congress in Vienna and were published in 22 August 2013 issue of The New England Journal of Medicine. Pazopanib demonstrated non-inferiority to sunitinib and shows a more favourable safety profile and improved patient reported quality of life domains.
Dr Robert Motzer of the Department of Medicine, Genitourinary Oncology Service, Memorial Sloan-Kettering Cancer Center, New York, USA and other study investigators randomised 1100 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 endpoint of progression-free survival (PFS) was assessed by independent review committee to give the study 80% power to detect non-inferiority of pazopanib to sunitinib. Key secondary endpoints included overall survival (OS), safety and quality of life.
Patient characteristics were balanced between arms. The non-inferiority of pazopanib was demonstrated; the upper bound of the 95% confidence interval for PFS was less than pre-specified 1.25. Median OS was similar, HR 0.91.
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 favoured pazopanib (p < 0.05 for all 11 comparisons).
The study was supported by GlaxoSmithKline Pharmaceuticals.