146PD Ginsenoside Rg3 improves transarterial chemoembolization treatment in Chinese patients with advanced hepatocellular carcinoma

Abstract

Purpose: This single-center, open-label, randomized, controlled trial aimed to evaluate the efficacy and safety of ginsenoside Rg3, a lowtoxicity vascular-endothelial growth factor (VEGF) inhibitor, when used to supplement transarterial chemoembolization (TACE). Material and Methods: Advanced hepatocellular carcinoma (HCC) patients with no prior systemic therapy were randomly divided to receive two daily oral Rg3 doses at 20 mg in combination with TACE (n=152) or TACE alone (n=76). The primary end-point was overall survival (OS). Secondary end points included time to progression (TTP), time to untreatable progression (TTUP), disease control rate (DCR), and safety. Results: Median overall survival was 13.2 months (95%CI 11.15-15.26) in the TACE+Rg3 group and 10.1 months (95%CI 9.14-11.06) in the TACE group (HR 0.63 [95%CI 0.46-0.85], p=0.002). Median TTP values were 4.3 (95%CI 3.32-5.28) and 3.2 (95%CI 2.51-3.89) months for TACE+Rg3 and TACE patients, respectively (HR 0.82 [95%CI 0.62-1.08], p=0.151). TACE+Rg3 patients had greater median TTUP (8.3 months [95%CI 7.05-9.55]) compared with 7.3 months [95%CI 6.40-8.20] obtained for the TACE group (HR 0.76 [95%CI 0.57-1.02], p=0.063). The most frequently reported Rg3-related grade 3/4 adverse events (constipation, 1.3%; hypertension, 3.9%) were alleviated by symptomatic treatment. Importantly, Rg3 alleviated some TACE-related adverse syndromes (ascites [23.7 vs 48.7%], anorexia [12.5 vs 44.7%], and fatigue [9.9 vs 50.0%], all p<0.01) and blood anomalies (anemia [36.8 vs 51.3%], leukopenia [46.7 vs 76.3%], thrombocytopenia [32.9 vs 50.0%], and hyperbilirubinemia [17.8 vs 34.2%], all p<0.05). Conclusion: In patients with advanced HCC and sufficient liver function, ginsenoside Rg3 improves TACE treatment.