A randomized, controlled trial of postoperative adjuvant cytokine-induced killer cells immunotherapy after radical resection of hepatocellular carcinoma

Background. With a resistance to conventional chemotherapy and radiotherapy, hepatocellular carcinoma has a high recurrence rate after radical resection. Adjuvant immunotherapy is a promising treatment for hepatocellular carcinoma. Aim. To evaluate the effect of adjuvant immunotherapy with cytokine-induced killer cells on the prognosis of hepatocellular carcinoma after radical resection. Patients and methods. From January 2000 to January 2002, we collected 127 patients that met the selection criteria and randomly divided them into 3 groups. After radical resection of the tumor, immunotherapy with cytokine-induced killer cells was per-formed for 3 courses in 41 patients (CIK-1 group) and 6 courses in 43 patients (CIK-II group). The other 43 patients received no postoperative adjuvant therapy (the control group). The 1-, 3-, and 5-year disease free survival rates and the overall survival were compared among the 3 groups. Results. The log-rank test showed that the disease-free survival rates were significantly higher in CIK-I group (p =0.001) and CIK-II group (p=0.004) than in the control group. No statistical significance was found between CIK-I group and CIK-II group (p=0.345). Cox regression suggested that treatment modality was a risk factor for recurrence. No statistical significance was found in the overall survival among the three groups. Conclusions. Postoperative immunotherapy with cytokine-induced killer cells may prevent recurrence/metastasis after radical resection of hepatocellular carcinoma. However, it cannot improve the overall survival. (C) 2008 Editrice Gastroenterologica Italiana S.r.l. Published by Elsevier Ltd. All rights reserved.