World GI 2016: Phase III RESORCE Study Data Show Regorafenib Improves Overall Survival in Previously Treated Patients With Unresectable Liver Cancer
Results from the phase III RESORCE trial show that regorafenib (Stivarga) tablets achieved a median overall survival improvement in patients with unresectable hepatocellular carcinoma (HCC) that progressed after treatment with sorafenib (Nexavar) tablets. The study, presented by Bruix et al during the European Society for Medical Oncology (ESMO) 18th World Congress on Gastrointestinal Cancer (Abstract LBA-03) in Barcelona, found that patients taking regorafenib had a median overall survival of 10.6 months vs 7.8 months for placebo plus best supportive care (hazard ratio [HR] = 0.62; 95% confidence interval [CI] = 0.50–0.78; P < .001).
“The global incidence of liver cancer continues to increase and has more than tripled in the United States over the past 3 decades, and currently there are no proven or approved systemic second-line treatment options for patients with advanced [hepatocellular carcinoma],” said Jordi Bruix, MD, Barcelona Clinic Liver Cancer Group, University of Barcelona, August Pi i Sunyer Biomedical Research Institute, Biomedical Research Networking Center in Hepatic and Digestive Diseases, Spain. “The improvement in overall survival seen with regorafenib in the RESORCE study signals the addition of a potential option in this treatment setting.”
Study Findings
In addition to the primary endpoint of the study, all secondary endpoints, which were assessed by modified Response Evaluation Critieria in Solid Tumors (mRECIST) and RECIST 1.1 criteria, were also met. Median progression-free survival was 3.1 months in patients taking regorafenib vs 1.5 months in the control group (HR = 0.46; 95% CI = 0.37–0.56; P < .001). Median time to progression was 3.2 vs 1.5 months (HR = 0.44; 95% CI = 0.36–0.55; P < .001). Disease control rate (composed of complete or partial response and stable disease) was 65.2% vs 36.1%, respectively (P < .001). Overall response rates (complete and partial responses) were 10.6% vs 4.1% (P = .005), respectively.
In the study, safety and tolerability were generally consistent with the known profile of regorafenib. The most common grade ≥ 3 treatment-emergent adverse events occurring more frequently in the regorafenib group (regorafenib vs placebo group) were hypertension (15.2% vs 4.7%), hand-foot skin reaction (12.6% vs 0.5%), fatigue (9.1% vs 4.7%), and diarrhea (3.2% vs 0%).
About RESORCE
The RESORCE [REgorafenib after SORafenib in patients with hepatoCEllular carcinoma] clinical trial is a randomized, double blind, placebo controlled, multicenter phase III study of regorafenib in patients with hepatocellular carcinoma whose disease has progressed after treatment with sorafenib. The trial enrolled approximately 573 patients who were randomized in a 2:1 ratio to receive either regorafenib plus best supportive care or placebo plus best supportive care.
Patients received 160 mg regorafenib once daily, for 3 weeks on/1 week off, or placebo with 28 days constituting one full treatment cycle. The primary endpoint of the study was overall survival, and secondary efficacy endpoints were time to progression, progression-free survival, objective tumor response rate, and disease control rate. Safety and tolerability of patients were continuously monitored.
Regorafenib Indications
In the United States, regorafenib is indicated for the treatment of patients with metastatic colorectal cancer who have been previously treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-VEGF therapy, and, if RAS wild-type, an anti-EGFR therapy. It is also indicated for the treatment of patients with locally advanced, unresectable, or metastatic gastrointestinal stromal tumor who have been previously treated with imatinib mesylate and sunitinib malate (Sutent).
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