Adjuvant Pazopanib After Surgery for Locally Advanced Renal Cell Carcinoma
Adjuvant pazopanib after nephrectomy was not found to be beneficial in patients at high risk for recurring local renal cell carcinoma, according to the results of the phase III PROTECT trial. The study, which was conducted by Robert J. Motzer, MD, of Memorial Sloan Kettering Cancer Center, and colleagues and published in the Journal of Clinical Oncology, showed insignificant improvement to the disease-free state over placebo. Starting doses of pazopanib required lowering due to toxicity.
A total of 1538 patients with locally advanced renal cell carcinoma who had undergone nephrectomy participated in the randomized trial for 1 year. The 403 patients assigned to the intent-to-treat group initially received pazopanib at 800 mg, which was ultimately lowered to 600 mg.
Analysis of the disease-free state was performed after 12 months of treatment. End-result hazard ratios were 0.86 in the placebo group compared with 0.69 in the pazopanib group. Patients in the intent-to-treat group were also found to experience elevated levels of alanine transaminase and aspartate transaminase, which contributed to treatment discontinuation in some patients regardless of the dose.