Ramucirumab Treatment Beneficial Across Hepatocellular Carcinoma Aetiologies: Presented at EASL

By Walter Alexander

VIENNA, Austria -- April 17, 2019 -- The benefit of ramucirumab for patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein after treatment with sorafenib is comparable regardless of disease aetiology, according to a study presented here at The International Liver Meeting, the 54th Annual Meeting of the European Association for the Study of the Liver (EASL).

Patients with advanced hepatocellular carcinoma and elevated alpha-fetoprotein have a poorer prognosis than the general population with hepatocellular carcinoma, said Peter Galle, MD, University Medical Center, Mainz, Germany, on April 12.

Hepatocellular carcinoma commonly occurs as a result of chronic liver disease secondary to viral hepatitis B or C or other causes, with alcohol use as the most common factor in developed countries. Factors contributing to prognosis in hepatocellular carcinoma are complex, Dr. Galle noted, and the contribution of the different aetiologies to overall hepatocellular carcinoma prognosis remains unclear.

Investigators in REACH-2 and REACH studied ramucirumab in patients with advanced hepatocellular carcinoma after treatment with sorafenib. REACH-2 enrolled only patients with baseline alpha-fetoprotein of ≥400 ng/mL and met its primary overall survival endpoint for ramucirumab versus placebo, consistent with findings for that population in REACH.

Dr. Galle conducted an exploratory analysis to investigate the efficacy and safety of ramucirumab in REACH (n = 815) and REACH-2 (n = 292) according to liver disease aetiology (hepatitis B, hepatitis C, other [e.g., significant alcohol use, steatohepatitis, cryptogenic cirrhosis]).

In both studies, patients had received ramucirumab 8 mg/kg every 2 weeks. Analysis showed that the benefit of ramucirumab versus placebo was consistent across aetiology subgroups (overall survival interaction, P = .29). Median overall survival with ramucirumab was 7.7 months in patients with hepatitis B, 8.2 months in those with hepatitis C, and 8.5 months in other patients. Median progression-free survival was 2.7 months in patients with hepatitis B, 3.6 months in those with hepatitis C, and 2.8 months for other hepatitis aetiologies.

Also, grade 3 or greater adverse events were consistent across subgroups, with hypertension being the most frequent grade 3 or higher adverse event.

“This exploratory analysis demonstrates a consistent treatment benefit with ramucirumab for patients with advanced hepatocellular carcinoma and alpha-fetoprotein ≥400 ng/mL regardless of aetiology. No significant prognostic factors were observed,” concluded Dr. Galle.

[Presentation title: Ramucirumab for Patients With Advanced Hepatocellular Carcinoma and Elevated Alphafetoprotein Following Sorafenib: Outcomes by Liver Disease Aetiology From Two Randomised, Placebo-Controlled Phase 3 Studies (REACH-2 and REACH). Abstract GS-2]

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