In the phase III double-blind, placebo-controlled CONCUR trial,1 previously treated patients with stage IV adenocarcinoma of the colon or rectum had increased overall survival, the primary endpoint, when treated with regorafenib (Stivarga). Regorafenib also improved progression-free survival, a secondary endpoint.
The study enrolled 204 patients in 25 centers in China, Hong Kong, Taiwan, Republic of Korea, and Vietnam. Patients were randomly assigned to receive best supportive care plus either oral regorafenib at 160 mg daily or placebo in the first 3 weeks of each 4-week cycle. Treatment was stopped at disease progression, unacceptable toxicity, or consent withdrawal.
Median overall survival was 8.8 months with regorafenib vs 6.3 months with placebo (hazard ratio [HR] = 0.550, P = .0002). Progression-free survival was 3.2 vs 1.7 months (HR = 0.311, P < .0001), and disease control rates were 52% vs 7%, respectively. ■
1. Li J, et al: CONCUR. Ann Oncol 25(suppl 2):114, 2014.