*Purpose: Hepatocellular carcinoma (HCC) recurrence after transplantation is associated with higher tumor grade on explant, failure to respond to DEB-TACE, and pretreatment lymphopenia. We prospectively monitored HCC patients in transplant evaluation to investigate associations between lymphopenia and tolerance with treatment response and waitlist outcomes.

*Methods: HCC patients undergoing DEB-TACE were prospectively enrolled. Blood was collected before and after DEB-TACE (100-300µm LC Beads with 100mg doxorubicin). Peripheral blood mononuclear cells were analyzed by flow cytometry. Tumor response to DEB-TACE was determined using mRECIST imaging criteria. Intention-to-treat (ITT) endpoint included transplantation or tumor progression.

*Results: Analyzed were 74 patients with a median age 61, predominantly Caucasian (75%) with Hepatitis C (76%). Prior to DEB-TACE, 46% of patients were lymphopenic (absolute lymphocyte count, ALC≤1.2k/μL). Tumor response was available in 68 patients. Lymphocyte status remained stable after DEB-TACE with no association between the change in ALC and treatment response. However, pre-treatment ALC and lymphopenia status were associated with failure to response to DEB-TACE (P=0.028, P=0.004). Overall, 68% of patients that did not respond to treatment were lymphopenic. ALC was negatively correlated with tolergenic immune populations, myeloid derived suppressor cells (R²=0.16) and regulatory T cells (Tregs, R²=0.22) and significantly elevated in lymphopenic patients (P=0.02 and P=0.001). Over half of cohort reached ITT endpoint with 26/41 transplanted and 18/41 having tumor progression. In the ITT cohort, 62% of patients that did not respond to DEB-TACE treatment experienced tumor progression.

*Conclusions: Pre-treatment assessment of lymphocytes in early stage HCC patients associates with DEB-TACE treatment response and can identify patients both at risk of tumor progression and recurrence post-transplant.

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