**2.1 Trials**

In a registration phase III trial, CORRECT (regorafenib monotherapy for previously treated metastatic colorectal cancer), 760 patients were randomized in a 2:1 ratio to receive regorafenib or placebo. The majority of patients were Caucasians (the study included only 111 Asians). Median OS turned out to be significantly longer in the regorafenib group than in the placebo group (6.4 vs. 5.0 months) [3]. In another randomized double-blind phase III trial, CONCUR, 204 patients with metastatic colorectal cancer after at least two lines of systemic therapy were randomized in a 2:1 ratio to receive regorafenib or placebo. All patients were Asians. Median OS in the regorafenib arm and placebo arm was 8.8 and 6.3 months, respectively. The results of this trial confirmed previous observations about the regorafenib efficacy. Toxicity profiles of regorafenib in both studies mentioned above were essentially similar [4]. However, these promising findings were not confirmed in another trial, PREVIUM, including patients with KRAS- or BRAFpositive metastatic colorectal cancer treated previously with FOLFOXIRI plus bevacizumab; median OS and median PFS in this group were 3.3 and 2.2 months, respectively [5].
