Background: HCC is a common indication for OLT. TACE and RFA are used as bridge therapies. These rarely result in complete eradication. Subsequent spread throughout the liver remains an issue. Sorafenib inhibits tyrosine kinase, disrupting the mechanism of phosphorylation, mutation and growth of HCCs. Clinical use in OLT has not been defined. Methods: A retrospective study of 164 patients who underwent OLT for HCC from 1/07 to 7/12 assessed the clinical efficacy of Sorafenib as a treatment for HCC. Target lesions (defined as radiographically indentified lesions greater than 1cm) according to Response Evaluation Criteria for Solid Tumors (RECIST) model with MRI imaging with/without contrast (gadolinium/Eovist) within 90 days of OLT, were correlated to explant pathology for size and number. Proliferation was compared on/off Sorafenib to analyze efficacy. Results: In this cohort, 62 (37.8%) were treated with Sorafenib pre-transplant. TACE was utilized concomitantly in 78% of sorafenib patients and 87% in the control. Using RECIST criteria, 76 patients not treated with sorafenib (control) had 98 target lesions (TL). 98 tumors had an average size of 1.95cm on pre-OLT imaging and 2.01cm on explant, with a median increase in size of 3%. 26.5% (n=26) of lesions showed progressive disease (PD), 60.2% (n=59) showed stable disease (SD) and 13.3% (n=13) showed positive response. 153 tumors were found on pathology compared to 98 detected on imaging, indicating 55 additional TL. Failed detection was 36% (55 of 153). 51 patients with 73 tumors meeting the criteria for TL were treated with sorafenib prior to OLT. Median duration of therapy was 33 wks. 73 tumors had an average size of 2.10 cm before treatment and 1.93 cm at explant with a mean decrease of 8%. 20.6% (n=15) of lesions showed PD, 53.4% (n=39) SD and 26.0% (n=19) showed PR. 98 tumors were found on pathology compared to 73 detected on imaging, indicating 25 additional TL. Failed detection was 26% (25/98). (74.2%) 46/62 patients on sorafenib experienced AEs. 19 (11.6%) continued sorafenib treatment post-OLT. Discussion: In this retrospective study, sorafenib pre-OLT treated lesions stabilized or improved in 79.4% vs. 74.0%. Sorafenib treated lesions decreased in size by 8% vs. 3%. Sorafenib rx had an associated decrease in undetected lesions until explant (25% vs. 36%). Conclusion: Sorafenib demonstrates an effect in decreasing the number of lesions unidentified on pre-OLT imaging. It also may have a modest effect treating established lesions.

Teperman, L.: Grant/Research Support, Onyx/Bayer.

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