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 performed for 3 courses in 41 patients (CIK-I 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.

RCT Entities:   Population Interventions Outcomes