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Results from the PROTECT clinical trial, a phase III trial of adjuvant pazopanib versus placebo after nephrectomy in patients with locally advanced renal cell carcinoma (RCC), were presented at the American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago yesterday.
1538 people with locally advanced RCC were randomised to receive pazopanib or placebo for 1 year after having their kidney surgically removed (nephrectomy) to evaluate the safety of pazopanib and its effectiveness at preventing recurrence of the cancer. During the study, the dose of pazopanib was decreased from 800 mg to 600 mg to improve tolerability. Disease-free survival in the people taking pazopanib was not significantly different compared with those taking placebo. However, there was a 31% reduction in the risk of recurrence in the people taking the 800 mg dose of pazopanib.
The safety profile of pazopanib was consistent with previous studies, and discontinuation of the study due to abnormal liver function tests was common in both pazopanib dose groups.
The primary disease-free survival endpoint was not met with pazopanib 600 mg, but a reduced risk of recurrence was reported with pazopanib 800 mg.