Comparative efficacy and safety of sorafenib in elderly versus non-elderly patients with advanced hepatocellular carcinoma (HCC) with varying liver dysfunction.

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430 Background: Sorafenib is the only FDA-approved systemic therapy for advanced HCC. The incidence of HCC increases with age, peaking above 70 years; however, we have limited efficacy and safety data in the elderly. Given the prevalence of HCC in South Texas, we assessed the efficacy and safety of sorafenib in the elderly. Methods: Retrospective analysis of HCC patients (pts) receiving sorafenib from 2008-2013. PFS and OS were estimated from Kaplan-Meier curves and groups were statistically compared with the log rank test. The magnitude of association between dichotomous factors and survival was estimated with the hazard ratio (HR). Adverse events (AEs) were graded according to the Common Terminology Criteria for Adverse Events version 4.0. Differences between age groups (65+, < 65) for dose reduction (yes, no), and AEs were analyzed using Fisher’s Exact Test. Results: A total of 118 pts were included. Median age 57 (range 41-93; 65+ 26%). males 81%. Hispanic 73%, Non-Hispanic White 24%. ECOG PS 0–1 93 %. Causes of cirrhosis: Hepatitis C 66%, Hepatitis B 4%, EtOH 58%. Portal vein thrombosis 36%, Extrahepatic disease 38%. Child-Pugh score: A 56%, B 44%. BCLC class: B 13%, C 87%. Among 113 pts 34% were started at 400 mg daily versus 66% started at 800 mg daily. mOS was 11.2 months (mo) (95% CI: 7.8-14.0), mPFS 5.2 mo (95% Cl: 3.9-7.1). In subgroup analysis, mOS for < 65 was 10.2 mo vs 13.5 mo for 65+ (HR 0.67, 95% CI: 0.39-1.16, p = 0.15). mPFS for < 65 was 4.6 mo vs 6.2 mo for 65+ (HR 0.92, 95% CI: 0.58-1.45, p = 0.71). Among 109 pts, dose reductions in < 65 vs 65+ were 64.6 vs 70% (P = 0.66); survival differences were not statistically significant. Among 75 pts there was a trend to improved survival in 65+ patients with AST/Platelet Ratio (APRI) < / = 1.68, but not statistically significant. Sorafenib was tolerated in the elderly. In regards to nausea, fatigue, diarrhea and hand foot syndrome, difference in toxicity was not statistically significant in < 65 versus 65+. Conclusions: In advanced HCC, elderly pts should be offered sorafenib, as it has efficacy and is tolerated in the elderly. Further prospective studies in the elderly are warranted, with evaluation of APRI as a prognostic marker.