Adjuvant Sunitinib Improves Survival in High-Risk RCC

Adjuvant treatment with the oral antiangiogenic drug sunitinib increases disease-free survival but increases toxicity in patients with metastatic renal cell carcinoma (RCC) at high risk of recurrence, reports a trial in The New England Journal of Medicine.

The randomized, international, phase 3 trial included 615 patients with locoregional, high-risk clear-cell RCC who had undergone nephrectomy. Intervention patients received sunitinib, 50 mg/d, on a 4-weeks-on, 2-weeks-off schedule. Treatment continued for up to 1 year; controls received placebo. Disease-free survival was compared between groups, along with secondary outcomes.

Sunitinib was associated with significant improvement in disease-free survival: 6.8 versus 5.6 years, hazard ratio 0.76. Overall survival could not be assessed at the time of data cutoff; about 20% of patients had died in each group.

Sunitinib was associated with increased toxicity, including higher rates of grade 3 and 4 adverse events and adverse events requiring dose reductions, interruptions, or discontinuation. The overall rate of serious adverse events was 21.9% with sunitinib and 17.1% with placebo, with no toxicity-related deaths.

Previous studies have established that sunitinib, a vascular endothelial growth factor pathway inhibitor, is an effective treatment for metastatic RCC. The new trial shows that adjuvant sunitinib can increase survival in patients with locoregional, high-risk clear-cell RCC. Sunitinib is associated with increased toxicity, leading to moderate declines in quality of life during active treatment [Ravaud A, et al. Adjuvant sunitinib in high-risk renal-cell carcinoma after nephrectomy. N Engl J Med October 10, 2016 DOI: 10.1056/NEJMoa1611406].

December 2016 (Vol 8, Issue 12)