What is the efficacy of pazopanib (Votrient) in the treatment of renal cell carcinoma (RCC)?

Updated: Feb 19, 2021
  • Author: Kush Sachdeva, MD; Chief Editor: E Jason Abel, MD  more...
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A phase III randomized study of pazopanib 800 mg orally daily confirmed statistically and clinically meaningful improvement of progression-free survival versus placebo (9.2 vs 4.2 months). The study enrolled 435 patients and randomized them to pazopanib or placebo in a 2:1 ratio; 233 (54%) of the patients were treatment naïve and 202 (46%) had prior cytokine therapy. In the treatment-naïve population, the difference in survival was much larger between pazopanib and placebo (11.1 vs 2.8 months).

Although final overall survival results showed no significant difference between the pazopanib and the placebo arms, extensive crossover from placebo to pazopanib confounded this analysis, and post-hoc analyses adjusting for crossover suggest an overall survival benefit with pazopanib. In this study pazopanib was well tolerated, with common adverse events including diarrhea (52%), hypertension (40%), hair color change (38%), nausea (26%), and anorexia (22%). [38]

In another phase III study, COMPARZ (Comparing the Efficacy, Safety, and Tolerability of Pazopanib vs Sunitinib) study, pazopanib was associated with a lower median overall survival (28.4 vs 29.3 months) and lower median progression-free survival (8.4 vs 9.5 months) than sunitinib, but the differences were not considered statistically significant. COMPARZ included 1110 treatment-naive patients with clear cell metastatic RCC and measurable disease, who were randomly assigned to treatment with either oral pazopanib 800 mg daily with continuous dosing or oral sunitinib 50 mg daily administered in 6-week cycles (4 weeks on/2 weeks off). [39, 40]

The pazopanib group had fewer dose interruptions of 7 days or more than did the sunitinib group (44% vs 49%) and fewer dose reductions (44% vs 51%); however, a higher proportion of patients in the pazopanib group discontinued the drug because of adverse events, primarily abnormalities in liver function tests (6% vs 1%). [39, 40] On the other hand, in another phase III trial (PISCES), 70% of patients selected pazopanib due to better quality of life, while 22% preferred sunitinib. [41]

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