Endolymphatic immunotherapy in inoperable hepatocellular carcinoma.

Introduction. We report the preliminary results of endolymphatic immunotherapy in patients with inoperable hepatocellular carcinoma (HCC). Methods. From 2003 to 2005 we enrolled 31 patients with inoperable HCC. The patients underwent monthly endolymphatic injections of 15-30 X 10(6) interleukin-2 (IL-2)-activated peripheral autologous lymphocytes (LAK) and 250 IU of IL-2. Follow-up included blood biochemistry every 3 months and imaging Studies every 6 months. To assess therapy efficacy we considered 12 biochemical parameters, vascular invasion or thrombosis, Child-Pugh scoring system, histological grading, lymphadenopathy, viral state, and alpha-fetoprotein. Results. Sixteen patients completed at least 3 cycles, and 10 patients completed more than 6. No clinically significant adverse reactions occurred. Imaging studies showed no significant decrease in tumor mass. However, the survival of patients who completed 12 therapy cycles was significantly higher than survival of patients with fewer than 12 cycles. Both are significantly higher than that of untreated patients. All patients with 12 completed cycles showed an improvement of 9 parameters or more. Discussion. Endolymphatic immunotherapy is safe, easily performed, inexpensive, and effective in terms of survival. This study should encourage future large-scale investigations so as to reach a firmer conclusion and define uniform inclusion criteria.