Would you consider systemic therapy in this patient?
The only systemic therapy that is currently approved is sorafenib. Sorafenib's indication is really for patients that have unresectable HCC. So within the FDA approval, this patient could be treated with systemic therapy. However, when you look at the data comparing systemic therapy to locoregional therapy, the survival benefit you appear to get from locoregional therapy appears to be better than with sorafenib. That being said, there is no randomized data comparing sorafenib to locoregional therapy in these patients, so there is an inherent selection bias of who's undergoing locoregional therapy and which patients are undergoing systemic therapy.
CASE 1: Unresectable Hepatocellular Carcinoma (uHCC)
Mario C is a 74-year-old retired steel worker from Allentown, Pennsylvania. His past medical history is notable for hepatitis B virus (HBV) infection (diagnosed in early 1990s).
In July 2013, patient was referred to a hepatologist with an elevated ALT (70 IU/mL) and AST (53 IU/mL).
Medical history is also notable for mild hypertension (currently controlled on antihypertensives) and hypercholesterolemia (currently controlled with diet); patient denies any alcohol use
Family history was relevant for an older brother who died of HCC and chronic HBV infection at age 70
On physical exam, no evidence of liver disease was noted and patient did not report any recent weight loss; patient reported some intermittent abdominal pain and there was mild tenderness in the lower right quadrant on palpation
Ultrasound revealed a poorly defined mass in the right lobe; contrast enhanced MRI showed a 12-cm mass in the lower right segment consistent with HCC and several smaller nodules. Bone scan and chest CT showed no evidence of metastatic disease
Patient presented to the Multidisciplinary Team (MDT) with Child Pugh Class A, with a MELD score of 7; patient’s performance status was 1
On surgical consult, the patient was deemed unresectable and the MDT recommended a TACE procedure for the larger lesion
In December of 2014, evidence of residual disease was detected on a follow up CT scan at the site of the first TACE procedure; smaller nodules also showed evidence of radiologic progression.
FDA Supports Phase 3 Plan for Amezalpat in Hepatocellular Carcinoma
August 16th 2024The FDA has given positive feedback on the planned phase 3 study for the combination of amezalpat, atezolizumab, and bevacizumab in the first-line treatment of unresectable or metastatic hepatocellular carcinoma.
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