Prognostic role of C-reactive protein levels in patients with hepatocellular carcinoma undergoing sorafenib therapy.

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340 Background: Markers of systemic inflammatory response including C-reactive protein (CRP) are associated with the prognosis of various malignancies including HCC. We investigated the significance of the serum CRP level as a prognostic factor in patients with advanced HCC on sorafenib therapy. Methods: The MSKCC institutional database was retrospectively queried for patients diagnosed with advanced HCC who received sorafenib therapy from 2002-2012 and had available serum CRP measurements. Patient demographics and outcomes were extracted under an IRB-approved waiver. Baseline CRP levels within 30 days of starting of sorafenib and while on sorafenib treatment were correlated with clinical outcomes. CRP levels after the initiation of sorafenib were analyzed as a time dependent covariate in a Cox regression model. Results: 51 patients had available CRP levels and received sorafenib: Median age 65 years (range 45-82); KPS 80 (70-90%); 9 females (17.6%); 32 AJCC stage IV disease (62.7%); 10 AJCC stage III (19.6%); 12 hepatitis C (23.5%), 10 hepatitis B (19.6%), 12 alcohol (23.5%), and 20 non-alcoholic steatohepatitis (39%); and 43 Child-Pugh A (84.3 %). The median time on sorafenib was 2.4 months (range 0.2-21.6). The median overall survival (OS) was 9.2 months [CI 5.8 – 13.6] and the median progression-free survival (PFS) was 2.1 months [CI 1.6 – 2.6]. 46 of 51 patients had baseline CRP levels available for analysis. Baseline CRP level was associated with OS [hazard ratio (HR) 1.2 (CI 0.996 – 1.4, p=0.056)] but not with PFS [HR 1.1 (CI 0.96-1.3, p=0.14)]. Time dependent covariate analysis demonstrated an association between CRP levels during sorafenib therapy and overall OS [HR 1.08 (CI 1.01-1.16, p=0.02)] as well as PFS [HR 1.09 (CI 1.02 – 1.16, p=0.009)]. Conclusions: Baseline CRP level prior to the start of sorafenib therapy showed a borderline significant association with OS but no association with PFS. Higher CRP levels showed a significant association with increased risk of disease progression and death for sorafenib treated HCC patients. Potential prognostic role of CRP in HCC patients undergoing sorafenib therapy is to be further studied prospectively.