Abstract
e15658 Background: HCC is associated with a worse prognosis in pts with high baseline AFP levels. The relationship between elevated baseline AFP and survival benefit with systemic HCC treatments in the real world setting is poorly characterized. Methods: A retrospective analysis of clinical outcomes among newly diagnosed advanced HCC pts treated in US community-based oncology practice settings was conducted. Pts treated with sorafenib or best-supportive care (BSC) between 10/1/2007 and 12/31/2013 were identified in the International Oncology Network electronic medical record (EMR) database and were followed until date of death, date of last visit, or 06/30/2014 (end of study). Baseline demographics, clinical characteristics, and AFP (≤ or > 400 ng/mL), plus date of death were extracted from the EMR and physician progress notes. Treatment differences in OS were evaluated and stratified by AFP, AST/ALT, and bilirubin using unadjusted Cox proportional hazards regression models. Results: A total of 370 advanced HCC pts receiving sorafenib (217) or BSC (153) were identified. The mean age was 65.6 years and 77.0% were male. Cirrhosis (38.4%), hepatitis C (36.8%), and alcoholic liver disease (22.4%) were common hepatic-related comorbidities. 45.1% of pts had elevated AFP ( > 400 ng/mL) at baseline. The sorafenib cohort had significantly longer median OS time than the BSC cohort (29.6 vs 19.7 weeks, p= 0.048). OS for sorafenib vs BSC cohorts with AFP≤400 ng/mL and AFP > 400 ng/mL were 45.1 vs 25.3 weeks ( p= 0.128) and 25.3 vs 13.1 weeks ( p =0.197), respectively. Cox models revealed a consistent effect of sorafenib vs. BSC, regardless of AFP level (AFP ≤400ng/mL: HR = 0.79 (95% CI 0.55-1.13), p= 0.200; AFP > 400 ng/mL: HR = 0.80 (95% CI 0.53-1.52), p= 0.297). Conclusions: This study supports the poor prognosis for advanced HCC pts with baseline AFP levels > 400 ng/mL compared to baseline AFP ≤400 ng/mL. Limitations with retrospective, real-world studies require caution in interpretation, but this analysis suggests an OS benefit with sorafenib treatment compared to BSC. There remains an unmet need for effective therapies for advanced HCC associated with elevated AFP levels.
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