ORLANDO, Fla.—Adjuvant treatment with sorafenib or sunitinib does not improve outcomes in patients who have undergone surgery for locally advanced kidney cancer, researchers reported at the 2015 Genitourinary Cancers Symposium.
“These drugs didn’t reduce disease recurrence, but on average they did not appear to worsen patient outcomes either,” said lead author Naomi B. Haas, MD, associate professor of medicine at the Abramson Cancer Center of the University of Pennsylvania in Philadelphia.
In the phase 3 ASSURE clinical trial, Dr. Haas and her colleagues randomly assigned 1,943 patients who underwent surgery for locally advanced, nonmetastatic renal cell carcinoma (RCC) to receive sorafenib, sunitinib, or placebo for 1 year. The patients were at high risk for cancer recurrence based on tumor size and grade, lymph node involvement, and other factors.
The sorafenib, sunitinib, and placebo arms included 649, 647, and 647 patients, respectively. The median disease-free survival times did not differ significantly among the study arms: 5.6, 5.6, and 5.7 years, respectively. The 5-year disease-free and overall survival rates for the sorafenib, sunitinib, and placebo arms also did not differ significantly: 52.8%, 53.8%, and 55.8%, respectively, and 80.7%, 76.9%, and 78.7%, respectively.
“The findings from this study suggest that patients with locally advanced kidney cancer completely resected should not be treated with either adjuvant sorafenib or sunitinib,” Dr. Haas said.