Real-World Findings in REFINE Study Support Use of Regorafenib in HCC

Richard S. Finn, MD, an assistant professor of clinical medicine at the Geffen School of Medicine at the University of California, Los Angeles (UCLA), and director of the Signal Transduction and Therapeutics Program at the Jonsson Comprehensive Cancer Center at UCLA, discusses the real-world findings from the REFINE study, which is exploring the outcomes of patients with unresectable hepatocellular carcinoma (HCC) who received treatment with regorafenib (Stivarga) compared with those in the clinical setting who were treated on the phase 3 RESORCE study.

In the real-world findings, just more than half of the doctors start patients on the full dose as prescribed, while others started patients at 80 or 120 mg per day, Finn says. Regardless, the efficacy and side effect profiles were similar between those treated in the real world versus the clinical trial setting.

Finn says that in terms of the length of time patients received regorafenib, the findings were comparable at about 4 months. Dose reductions were fairly common, regardless of the dose.

When investigators looked at why doctors used a lower dose, there seemed to be a relation with their prior dose of sorafenib (Nexavar). In the RESORCE study, patients received a fixed dose of regorafenib, and there was no effect on the efficacy and tolerability of the drug. Patients who were on sorafenib for a shorter period of time, they still received a similar magnitude of benefit with regorafenib, and vice versa, Finn says.