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Observation on the effect of adoptive immunotherapy with activated autologous lymphocytes in the treatment of primary hepatocellular carcinoma
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Abstract:
Objective: To evaluate whether adoptive immunotherapy (AIT) with activated autologous lymphocytes helps to improve the clinical efficacy of primary hepatocellular carcinoma. Methods: Sixty-four patients with primary hepatocellular carcinoma diagnosed at the Fifth Medical Center of Chinese PLA General Hospital from August 2016 to December 2018 were enrolled and divided into immunotherapy group (n=29) and control group (n=35) by the stratified randomized sampling method. 60 ml of peripheral blood was drawn from each patient in the immunotherapy group to prepare mononuclear cells, which were then activated and cultured in a medium containing OKT-3 and IL-2. A quality control test was done before blood re-transfusion. In the immunotherapy group,patients in stage Ⅰ-Ⅲ (n=14) received autologous lymphocyte infusion (6 infusions within 3 months) after first-line treatment, while patients in stage Ⅳ (n=15) only received autologous lymphocyte infusion therapy. Patients in the control group received other hepatocellular carcinoma-related treatments. The primary endpoint of the efficacy evaluation was the 2-year relapse-free survival (RFS), and the secondary endpoints were progression-free survival (PFS) and overall survival (OS). Results: The median follow-up time of the enrolled patients was 2.8 years (0.2-4.2 years). 29 patients in the immunotherapy group received a total of 167 scheduled lymphocyte infusions (with an average of 9.30×109 cells per patient, of which CD3+HLA-DR cells accounted for about 63%; 174 infusions were planned, with a completion rate of 96%). During the treatment period, no grade 3-4 adverse reactions were observed.Compared with the control group, patients in the immunotherapy group had a significantly increased 2-year RFS rate (62.1% vs 22.9%,OR=0.181, 95%CI: 0.06-0.54, P=0.002), and the median PFS (28 vs 8 months, P=0.004) and median OS (38 vs 34 months, P=0.915) were significantly prolonged. Among the patients at stage Ⅰ-Ⅲ, the PFS rate in the immunotherapy group was significantly higher than that in the control group (92.9% vs 33.3%, OR=0.38, 95%CI: 0.004-0.368, P=0.005), and the median PFS was significantly prolonged (38 vs 14.5 months, P=0.005), but there was no significant difference in OS between the two groups. In stage Ⅳ patients, there was no statistical difference in PFS (P=0.077) and OS (P=0.994) between the two groups. Conclusion: AIT with activated autologous lymphocytes is a safe and feasible adjuvant therapy for hepatocellular carcinoma, which can improve RFS rate after first-line treatment of stage Ⅰ-Ⅲ hepatocellular carcinoma and prolong the recurrence-free survival time of patients. It has no significant effect on PFS and OS in patients with advanced hepatocellular carcinoma.
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Project Supported:
Project supported by the Major Project of Military Logistics Research (No. AWS17J010)
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