Regorafenib for the treatment of unresectable hepatocellular carcinoma

ABSTRACT

Introduction: Sorafenib is the standard of care for patients with advanced hepatocellular carcinoma (HCC) and well preserved liver function. However, until recent approval of regorafenib by the Food and Drug Administration (FDA), no effective therapeutic options were available for patients resistant to sorafenib.

Areas covered: The present article reviews the preclinical and clinical data of regorafenib, putting them into the context of current and future landscape of treatment options for patients with HCC. Recently, the randomized, placebo-controlled, Phase III RESORCE trial, demonstrated a statistically and clinically significant increase in overall survival from 7.8 months with placebo to 10.6 months with regorafenib in patients progressing on sorafenib. Furthermore, the study showed a significant improvement in all the other efficacy endpoints. Main adverse events were hypertension, hand-foot skin reaction, fatigue and diarrhea, with no negative impact on quality of life.

Expert commentary: Regorafenib is a recently approved treatment option for HCC patients who have been previously treated with sorafenib. The RESORCE trial demonstrates the beneficial effect of a sequential approach involving two multikinase inhibitors, namely sorafenib and regorafenib, whose antitumor activity extends beyond their antiangiogenic functions.

KEYWORDS:

• Hepatocellular carcinoma
• advanced/metastatic
• second-line
• regorafenib
• angiogenesis

Information resources

• https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm555548.htm

• https://gicasym.org/daily-news/reflections-resorce-second-line-regorafenib-hcc-study

• http://www.targetedonc.com/news/regorafenib-success-spurs-optimistic-outlook-for-the-future-of-hcc

• http://www.healio.com/hepatology/oncology/news/online/%7B9356cd65-8a0d-48f7-88be-f618de7e4fde%7D/stivarga-improves-os-for-unresectable-hcc

• https://www.nice.org.uk/Media/Default/About/what-we-do/NICE-guidance/NICE-technology-appraisal-guidance/proposed-technology-appraisals/regorafenib-hepatocellular-carcinoma-draft-scope.pdf

Declaration of interest

L Rimassa has acted as a consultant/in an advisory role for Bayer and Eli Lilly. A. Santoro has acted as a consultant/in an advisory role for ArQule and Bayer. The authors have no other relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript apart from those disclosed.

Additional information

Funding

This work has received no funding.