Endolymphatic immunotherapy for advanced hepatocellular carcinoma: an update of our experience

Abstract

Aim: We report an update of our experience on endolymphatic immunotherapy in patients with advanced hepatocellular carcinoma (HCC) not eligible for surgery.

Methods: From 2003 to 2009 we enrolled 39 patients with advanced HCC not suitable for surgery. Patients underwent monthly endolymphatic injections of 1.5 × 10⁶-3.0 × 10⁶ IL-2-activated peripheral autologous lymphocytes and 250U of IL-2. Blood biochemistry every 3 months and imaging studies every 6 months were performed. Evaluation of the results was done according to clinical and pathological characters mainly including etiology, Child-Pugh class, size and number of lesions, α-fetoprotein, lymphadenopathy, vascular invasion, Response Evaluation Criteria in Solid Tumours criteria for tumour burden, biochemical parameters and survival rates.

Results: Ten patients completed 12 therapy cycles, 6 received 6 infusions, 10 only 3-4 injection and 13 patients received less than 3 injections and where considered not suitable for evaluation. No clinically significant adverse reactions occurred. Imaging studies showed no significant decrease in tumour mass. Survival of treated patients was significantly higher with respect to control group (P < 0.0001). The 1-year survival was 0% in the control group vs. 50% in the treated group. In addition survival of patients who completed 12 therapy cycles appeared higher with respect to patients who underwent less than 6 cycles without reaching statistical significance due to the small number of patients. All patients with 12 completed cycles showed an improvement of 9 parameters or more.

Conclusion: Endolymphatic administration of immunotherapy appeared safe, easy to perform and effective in terms of survival. This study should encourage future large scale studies in order to reach a firmer conclusion and define uniform inclusion criteria.

Keywords

Hepatocellular carcinoma / endolymphatic / immunotherapy / survival

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