The Bayer poster P-115 entitled “Sequential Treatment With Sorafenib Followed By Regorafenib In Patients With Unresectable Hepatocellular Carcinoma (HCC): Interim Analysis Of The Observational REFINE Study”, has been selected as one of the 10 top scored clinical e-Posters presented at the 2020 virtual ILCA congress.
This poster shows data from an interim analysis of the REFINE study ‒ an ongoing, prospective, observational, post-authorization safety study designed to evaluate the safety and effectiveness of regorafenib in patients with HCC in real-world practice.
REFINE Study Design
This planned interim analysis was carried out after the first 500 out of 1000 patients had been in the study for at least 4 months.
Though most patients (97%) had received prior sorafenib, the patient population in REFINE is broader than those in the phase 3 RESORCE trial, reflecting the less stringent inclusion criteria of a real-world study including more patients with Child–Pugh B liver disease, ECOG PS ≥2 and sorafenib-intolerant patients.
Among all regorafenib-treated patients, the most frequent treatment emergent adverse events (any grade) were hand-foot skin reaction (30%), diarrhea (21%), fatigue (16%), and decreased appetite (14%). Despite the more varied patient population, the safety profile of regorafenib was consistent with that reported in RESORCE, with no unexpected safety signals.
Median OS was 13.2 months for all patients treated with regorafenib and 14.8 months in patients who received regorafenib as second-line treatment after sorafenib. Median OS in patients who received regorafenib second line after sorafenib was longer than in RESORCE, but there was a high proportion of censored patients in this interim analysis.
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