In the phase III RESORCE trial, regorafenib improved overall survival (OS) vs placebo in patients with uHCC who progressed on sorafenib.
REFINE is an international, prospective observational study that recruited patients with uHCC. The primary aim is to assess treatment-emergent adverse events (TEAEs). Secondary endpoints include OS, progression-free survival, and tumor response. At ESMO 2020, the authors presented interim results for 182 patients who enrolled in REFINE from Korea (70%), China (26%), and Taiwan (4%).
The median age was 60 years and 80% of them were male. Majority of these patients had ECOG 0 (37%) or 1 (49%) and a Child-Pugh A (70%) or B (5%). The initial daily regorafenib dose was 160 mg (70%), 120 mg (14%) and 80 mg (15%) respectively. Median treatment duration was 3.2 months.
TEAEs reported among Asian patients were consistent with those reported in the phase III RESORCE trial, with grade 3 or higher AEs seen in 11% of the patients, which include diarrhea (2%), limb syndrome (1%), hypertension (1%) and fatigue (1%). There were no grade 4/5 adverse events observed. Notably, incidence rates of some TEAEs were lower than in RESORCE.
The study results also showed that the median overall survival (OS) for the 182 patients was 16.3 months, a 52% increase compared to 10.6 months seen in the RESORCE study. This median OS was also longer than 13.2 months shown in the total cohort of the REFINE study.