Among patients with no evidence of disease )(NED) who had been treated with metastasectomy for metastatic renal cell carcinoma (mRCC), the risk for recurrence is high. However, there is no systemic therapy currently recommended for that patient population.
Pazopanib (a VEGFR inhibitor) has been shown to improve survival in patients with measurable RCC metastatic disease. Leonard Joseph Appleman, MD, PhD, and colleagues hypothesized that pazopanib would improve disease-free survival in patients with mRCC who had NED following metastasectomy. The researchers reported results of a randomized, double-blind, placebo-controlled multicenter study testing that hypothesis at the ASCO Annual Meeting 2019.
Patients with NED after metastasectomy were randomized 1:1 to receive pazopanib 800 mg daily or placebo for 52 weeks. Clinical assessments for toxicity and patient-reported outcomes were performed every 4 weeks; restaging scans were performed every 12 weeks. The study was designed to observe a 42% improvement in disease-free survival (DFS) from 25% to 45% at 3 years.
One hundred patients were enrolled from August 2012 to July 2017. Following observance of 83 DFS events, the study was unblinded. The study did not meet the primary endpoint: hazard ratio for DFS was 0.85 (95R confidence interval, 0.55-1.31); P=.47 in favor of pazopanib. The hazard ratio for overall survival was 2.65 in favor of placebo.
In conclusion, the researchers said, “Fifty-two weeks of pazopanib did not improve DFS compared to blinded placebo in patients with mRCC who were NED after metastasectomy. There was a trend toward worse overall survival with pazopanib.”
Clinical trial information: NCT01575548
