Comparative efficacy and safety analysis of sorafenib in patients with advanced hepatocellular cancer (HCC) with varying liver dysfunction: A south Texas institutional analysis.

Abstract

e15171 Background: Sorafenib (SOR) is the first systemic therapy to improve survival in patients (pts) with advanced (HCC), mainly amongst pts with Child-Pugh (CP) A cirrhosis. In the US however, HCC pts often present with ECOG status ≥ 1 and CP B cirrhosis. The GIDEON study reported variation in disease characteristics and treatment patterns for US pts compared to rest of the world. Our aim was to further assess clinical efficacy and safety of SOR at our institution’s minority rich South Texas HCC population. Methods: We reviewed medical records of HCC pts who received SOR from 2008-2011. The association between demographic, clinical and laboratory variables with overall survival (OS) and progression free survival (PFS) were assessed by comparison of Kaplan-Meier curves. Groups were statistically compared by the log rank test and the magnitude of association with outcome was summarized as the hazards ratio with 95% confidence interval (CI). Results: A total of 67 pts were included. Median age 55 (range 41-93), males 83%, Hispanic 76%, CP A 59% vs B 39%. The median OS (mOS) was 10.0 months (mo) (95% CI: 7.2-18.3) and median PFS (mPFS) was 4.9 mo (95% CI: 3.1-7.1); both comparable to reported efficacy of the SHARP trial. In subgroup analysis, mOS was 12.8 (95% CI: 7.7–18.3) vs 7.2 mo (95% CI: 2.6–24.4) for CP A and B (HR 0.72, 95% CI: 0.37–1.38, p = 0.32), respectively. CP A pts had a mPFS of 5.9 (95% CI: 1.6–10.0) vs 3.6 mo (95% CI: 4.4–7.6) with CP B pts (HR 0.77, 95% CI: 0.45–1.34, p = 0.36). Pts on SOR daily dose of 800 mg had a better mOS at 12.8 (95% CI: 6.9–24.4) vs 8.7 mo (95% CI: 2.0–15.8) compared to those on 400 mg (HR 0.58, 95% CI: 0.29–1.15, p = 0.11). Although no significant difference in efficacy was noted between ethnicities, pts ≥ 60 years had an improved mOS at 15.9 (95% CI: 6.9–24.4) vs 7.9 mo (95% CI: 2.0–15.8) amongst pts < 60 (HR 0.56, 95% CI: 0.28-1.12, p = 0.10). There was no difference in toxicity observed. Conclusions: SOR was well tolerated in both CP A and B groups. Efficacy analysis showed a trend towards improved survival among pts with CP A treated with a daily dose of 800mg. The improved efficacy of SOR among pts ≥ 60 may be related to a more indolent HCC in this age group.