(71) Real-World Effectiveness and Safety of Ramucirumab in Hepatocellular Carcinoma Patients: A Retrospective Study in Taiwan

Publication Number: 745

Background: Ramucirumab, a human IgG1 monoclonal antibody that inhibits ligand activation of Vascular endothelial growth factor receptor 2 (VEGFR2), were approved to treat sorafenib-failure hepatocellular carcinoma (HCC) patients. However, real-world evidence on ramucirumab remained unclear.

Objectives: The present study aimed to evaluate the real-world effectiveness and safety of ramucirumab from Asian population.

Methods: We conducted a retrospective cohort study by using a multi-institutional electronic medical records database in Taiwan. We included the advanced HCC patients with newly receiving ramucirumab as second-line or more systemic therapy from January 2016 to November 2021. We further excluded the patients with combination of chemotherapy or other tyrosine kinase inhibitors. The first date of ramucirumab use was defined as index date. We followed patients from the index date to patients’ death, loss of follow-up, or January 31, 2022. The clinical outcomes were α-fetoprotein (AFP) level changes, tumor response according to modified Response Evaluation Criteria in Solid Tumors (mRECIST) and adverse events. We described the patients’ characteristics and study results by mean and interquartile range (IQR) for continuous variables, and absolute and relative frequencies for categorical variables.

Results: We included 31 ramucirumab new users with a median age of 65.5 (IQR: 56.0-75.0) years and treatment time of 6.0 (4.0-7.0) cycles, of whom 83.8% were male and 80.6% were Barcelona Clinic Liver Cancer (BCLC) stage C. Extrahepatic metastases were present in 19 (61.3%) patients and vascular invasion was present in 12 (38.7%) patients. Most patients had AFP level more than 200 ng/ml (96.8%). After ramucirumab treatment, 44.8% patients’ AFP level decreased more than 20% within 12 weeks and 22.5% had tumor progression within median time of 2.3 months. Post-treatment ascites was observed in thirteen patients.

Conclusions: The real-world effectiveness and safety of ramucirumab was similar to the Asia subgroup in REACH-2 trials. Future large-scale studies are suggested to confirm our findings.