Compared with a placebo, treatment with the oral, targeted drug Votrient® (pazopanib) delays progression of advanced kidney cancer. The results of this Phase III clinical trial were published in the Journal of Clinical Oncology.
The kidneys are filled with tiny tubules that clean and filter the blood; this process removes waste and makes urine. Renal cell cancer (RCC) is a malignancy involving these tubules of the kidney. It is the most common type of kidney cancer.
Votrient is a targeted oral medication known as an angiogenesis inhibitor. The drug may help slow or prevent the growth of new blood vessels, which deprives the cancer of the oxygen and nutrients it needs to grow.
The efficacy of Votrient in locally advanced or metastatic RCC was evaluated in a Phase III clinical trial. The study enrolled 233 previously untreated patients and 202 patients who had previously been treated with either interferon or interleukin. Patients were assigned to receive either Votrient or a placebo.
- Treatment with Votrient delayed cancer progression. Progression-free survival was 9.2 months among patients treated with Votrient compared with 4.2 months among patients given a placebo.
- The benefit of Votrient was particularly apparent among previously untreated patients. In these patients progression-free survival was 11.1 months among patients treated with Votrient compared with 2.8 months among patients given a placebo. Among previously treated patients, progression-free survival was 7.4 months among patients treated with Votrient and 4.2 months among patients given a placebo.
- Patients will continue to be followed in order to asses Votrient’s effect on overall survival.
- The most common side effects of Votrient were diarrhea (52%), high blood pressure (40%), hair color changes (38%), nausea (26%), weight loss (22%), and vomiting (21%).
The results of this study suggest that compared with placebo, Votrient delays progression of advanced kidney cancer.
The FDA approved Votrient™ (pazopanib) for the treatment of advanced renal cell carcinoma (kidney cancer). The approval of Votrient came after the results of a Phase III trial showed that the drug reduced the risk of tumor progression or death by 54% compared with placebo, regardless of prior treatment. Overall median progression-free survival was 9.2 months with Votrient compared with 4.2 months with placebo. Treatment-naïve patients experienced an even longer progression-free survival with Votrient (11.1 months compared with 2.8 months with placebo).
The most common adverse events associated with Votrient included diarrhea, hypertension, nausea, vomiting, anorexia, and changes in hair color.
- FDA Approves New Treatment for Advanced Form of Kidney Cancer [FDA News Release]. US Food and Drug Administration Web site. Available at: . Accessed December 4, 2009.
- Sternberg CN, Davis ID, Mardiak J et al. Pazopanib in locally advanced or metastatic renal cell carcinoma: results of a randomized phase III trial. Journal of Clinical Oncology [early online publication]. January 25, 2010.