Evidence in the HCC Adjuvant Setting

Anthony El-Khoueiry, MD:The recurrence was in August of 2016, and the patient was then started on sorafenib at 400 mg/twice-daily. He tolerated the treatment well and had stabilization of the disease until April of 2017, when he was noted to have progression. The question is whether or not a patient who undergoes surgical resection would have adjuvant treatment, and the short answer is no, because there is no established standard at this point.

The STORM trial, which evaluated the usage of adjuvant sorafenib post resection or post ablation versus best supportive care or placebo, showed no survival benefit with the usage of adjuvant sorafenib. Based on this, there is no current standard adjuvant treatment. There is a reported trial from Asia, from Korea, that used cytokine-induced killer cells—which were infused post-resection or ablation as adjuvant treatment versus best supportive care—which showed an improvement in survival and progression-free survival in that setting.

Now this study was relatively small and was done in a particular group of patients that mostly had hepatitis B and relatively small tumors, and a large proportion of these patients had ablative therapy rather than resection. So, follow-up studies would be needed to validate these results and ensure that they’re applicable to a broader patient population. But there is some promise with this approach. I believe that there are plans in the future to evaluate other therapies in the adjuvant setting, including, potentially, immunotherapy.

Transcript edited for clarity.

February 2014

• A 63-year old male with HBV
• ECOG=0
• Child-Pugh A; platelet count 230,000 cells/mcL
• Bilirubin 1.0 mg/dL; Albumin 3.5 g/dL
• CT scan revealed liver lesions, 1 is 2-cm; 1 is 5-cm both in the right lobe
• No extrahepatic disease
• Biopsy confirmed HCC diagnosis
• AFP=5400 IU/ml
• Tumors were resected with RO margin

August 2016

• Imaging showed recurrence in the liver, metastatic disease in the lungs
• Therapy was initiated with sorafenib 400 mg BID
• Therapy was well-tolerated

April 2017

• Radiographic progression with multiple lung metastases
• ECOG=0
• Therapy with regorafenib initiated at 160 mg
• Starting dose was well-tolerated, patient experienced some fatigue