The following is a summary of “Pazopanib in Locally Advanced or Metastatic Renal Cell Carcinoma: Results of a Randomized Phase III Trial,” published in the April 2023 issue of Oncology by Sternberg, et al.
An oral angiogenesis inhibitor called pazopanib works by blocking the c-Kit, platelet-derived growth factor receptor, and vascular endothelial growth factor receptor. For a study, researchers sought to evaluate the efficacy and safety of pazopanib, an oral angiogenesis inhibitor, in treating advanced renal cell carcinoma (RCC) in treatment-naive and cytokine-pretreated patients.
In the randomized, double-blind, placebo-controlled phase III study, adult patients with measurable, locally advanced, and/or metastatic RCC were randomly assigned 2:1 to receive oral pazopanib or placebo.
Progression-free survival (PFS) was the main outcome, while secondary outcomes were overall survival, tumor response rate, and safety.
Of the 435 patients enrolled, 233 were treatment-naive (54%), and 202 were cytokine pretreated (46%). Pazopanib significantly prolonged PFS compared with placebo in the overall study population (median PFS 9.2 v 4.2 months; hazard ratio [HR], 0.46; 95% CI, 0.34 to 0.62; P < .0001), the treatment-naive subpopulation (median PFS 11.1 v 2.8 months; HR, 0.40; 95% CI, 0.27 to 0.60; P < .0001), and the cytokine-pretreated subpopulation (median PFS, 7.4 v 4.2 months; HR, 0.54; 95% CI, 0.35 to 0.84; P < .001). Moreover, pazopanib had an objective response rate (30%) that was higher than the placebo’s (3%) (P< .001), and the median response time was longer than a year. Diarrhea, hypertension, hair color changes, nausea, anorexia, and vomiting were the most frequent side effects. No clinically important differences in quality of life were observed between pazopanib and placebo.
Pazopanib significantly improved PFS and tumor response compared with placebo in treatment-naive and cytokine-pretreated patients with advanced and/or metastatic RCC. Adverse events were generally manageable, and there were no significant differences in quality of life between pazopanib and placebo.