Regorafenib: a review of its use in previously treated patients with progressive metastatic colorectal cancer.

Regorafenib (Stivarga) is an inhibitor of multiple protein kinases, including those involved in oncogenesis, tumour angiogenesis and maintenance of the tumour microenvironment. The drug is approved as monotherapy for the treatment of metastatic colorectal cancer (mCRC) in patients who have previously received all standard systemic anticancer treatments (US, EU and Canada) or in patients with unresectable, advanced or recurrent colorectal cancer (Japan). In the randomized, controlled COloRectal cancer treated with REgorafenib or plaCebo after failure of standard Therapy (CORRECT) trial, regorafenib 160 mg once daily for the first 3 weeks of each 4-week cycle plus best supportive care (BSC) was associated with a significantly longer median overall survival than placebo plus BSC in patients with previously treated, progressive mCRC. The drug was also associated with significantly longer progression-free survival and better disease control rates than placebo, although objective response rates were similar in both treatment groups. Regorafenib did not appear to compromise health-related quality of life over the study duration and had a generally acceptable tolerability profile. The introduction of regorafenib expands the currently limited range of effective treatment options in patients with previously treated, progressive mCRC.