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Gastrointestinal Cancers: mCRC (Issue 6)

A first-in-human phase I dose-escalation study followed by a small expansion cohort, both of which were conducted solely in Germany, set the stage for what would soon become the FDA-approved dose for regorafenib (Stivarga) of 160 mg/day.

"While adverse events across both populations were broadly similar, some did occur more frequently in patients with longer exposure, an observation that is possibly related to the longer duration in this subgroup," said Axel Grothey, MD.

Regorafenib offers a unique challenge in terms of AE management. AEs with regorafenib have been reported across several clinical trials, and more recently, a clinical case study demonstrated the utility of regorafenib in a "real world" scenario, adding further insight.