Regorafenib in Chinese patients with metastatic colorectal cancer: Subgroup analysis of the phase 3 CONCUR trial

Background and Aim In the phase 3 CONCUR trial (NCT01584830), regorafenib improved overall survival (OS) versus placebo in Asian patients with treatment‐refractory metastatic colorectal cancer (mCRC). We conducted a post hoc subgroup analysis of Chinese patients in CONCUR. Methods Adults with mCRC progressing despite at least two prior treatment regimens and Eastern Cooperative Oncology Group performance status 0–1 were randomized 2:1 to regorafenib 160 mg once daily or placebo for the first 3 weeks of each 4‐week cycle. Dose modifications were permitted. The primary endpoint was OS. Secondary endpoints included progression‐free survival, objective overall response, disease control rate, and safety. Results A total of 172 Chinese patients were randomized and treated (regorafenib n = 112, placebo n = 60). OS was significantly improved with regorafenib versus placebo (8.4 vs 6.2 months, respectively; hazard ratio [HR] 0.56, 95% CI 0.39–0.80; one‐sided P = 0.000632), as was progression‐free survival (HR 0.32, 95% CI 0.22–0.47; one‐sided P