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Regorafenib for Hepatocellular Carcinoma in Real-World Practice (REFINE): A Prospective, Observational Study
Yoon Jun Kim1, Philippe Merle2, Richard S Finn3
1Department of Internal Medicine and Liver Research Institute, Seoul National University Hospital, Seoul, Republic of Korea.
Liver Cancer
|August 20, 2025
Summary
Regorafenib demonstrated safety and effectiveness in a real-world study of unresectable hepatocellular carcinoma (uHCC) patients, consistent with prior trial findings. This confirms its value in broader clinical practice for uHCC treatment.
Area of Science:
- Hepatobiliary Cancers
- Medical Oncology
- Clinical Pharmacology
Background:
- Unresectable hepatocellular carcinoma (uHCC) poses significant treatment challenges.
- Regorafenib is approved for uHCC after sorafenib progression, based on the RESORCE trial.
- Real-world data is needed to confirm effectiveness and safety in diverse patient populations.
Purpose of the Study:
- To evaluate the safety and effectiveness of regorafenib in a broad, real-world uHCC patient population.
- To assess treatment-emergent adverse events (TEAEs) and dose modifications in clinical practice.
- To compare findings with the phase 3 RESORCE trial.
Main Methods:
- Prospective, observational, international, multicenter study (REFINE).
- Enrolled patients with uHCC treated with regorafenib per physician decision.
- Primary endpoint: safety, including incidence of TEAEs and dose modifications.
Main Results:
- 1,005 patients initiated regorafenib; median age 66 years.
- 45% experienced dose modifications and 31% discontinued regorafenib due to TEAEs.
- Most common TEAEs: hand-foot skin reaction (31%), diarrhea (26%), fatigue (15%). Median overall survival (OS) was 13.2 months.
Conclusions:
- The REFINE study confirms regorafenib's safety and effectiveness in a broad, real-world uHCC population.
- Findings are consistent with the RESORCE trial, supporting regorafenib use in clinical practice.
- Real-world data validates regorafenib as a treatment option for patients with uHCC.
