Impact of virologic factors on recurrence-free survival in HBV-related hepatocellular carcinoma after surgical resection: Post hoc analysis from a prospective study with long-term follow-up.

e15032 Background: To investigate the impact of virologic factors on recurrence of post-operative hepatitis B virus (HBV)-related hepatocellular carcinoma (HCC) in a prospective study population with long-term follow-up. Methods: 183 patients who had participated an adjuvant trial with detectable HBV DNA and of genotype B and/or C and negative for anti-hepatitis C antibody were included. All analyses were censored upon Dec 30st, 2010. Results: The genotype distribution was B in 99 (54.1%), and C or mixed B+C (C/B+C) in 84 (45.9%). Genotype C/B+C infected patients had significantly higher incidence of HBeAg-seropositivity, high baseline HBV viral load, elevated serum ALT level, and underlying cirrhosis than patients with genotype B infection. The median time-to-recurrence (TTR) was 94.9 months and 33 months for genotype B and C/B+C infected patients, respectively (p=0.0495), and that for viral titer <104 and ≥104 copies/mL was 129.8 and 39.9 months, respectively (p=0.059). Tumor size >5 cm (p=0.008), presence of venous invasion (p=0.007) and moderately or poorly differentiation (p=0.039) were adverse prognostic factors for TTR in multivariate Cox’s regression analysis, but neither HBV DNA titer nor genotype. Of patients with tumor size ≤5 cm, HBV genotype C/B+C and baseline HBV viral load ≥104 copies/mL are significant adverse prognostic factors for TTR. On the other hand, microvascular invasion but not viral factor was prognostically significant for tumor size >5 cm subpopulation. Compared with patients with neither genotype C/B+C infection nor baseline viral load ≥104 copies/mL, the relative risk for TTR of patients with either and both of the virological risk factors was 2.581 (p=0.068) and 3.384 (p=0.019), respectively, for the entire study cohort. Conclusions: HBV genotype and baseline viral load are associated with risk of recurrence in post-operative HCC, especially in patients with tumor ≤5 cm. Adjuvant anti-viral therapy may be more likely benefit to curatively resected small HBV-related HCC patients, which is currently tested in TCOG1206 trial.