Cytokine-Induced Killer Cells Boost RFS, CSS in HCC in Extended Follow-Up

By Emily Menendez - Last Updated: January 24, 2025

Previous real-world data and outcomes of a randomized controlled trial (RCT) have pointed to the benefit of adjuvant immunotherapy for patients with hepatocellular carcinoma (HCC) through the use of autologous cytokine-induced killer (CIK) cells, with the treatment providing improved recurrence-free survival (RFS).

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A two-part study presented at the American Society of Clinical Oncology 2025 Gastrointestinal Cancers Symposium assessed the RCT’s longer-term outcomes and analyzed the potential underlying mechanisms of sustained effects of CIK cell treatment in HCC.

The study included a long-term follow-up of the RCT, along with an analysis of immune cells in patients who received adjuvant CIK cell treatment. The original RCT included 226 patients who underwent treatment with curative intent for stage I or II HCC.

A total of 114 patients underwent CIK cell treatment consisting of 16 injections of 6.4 × 109 CIK cells over an 11-month period, and 112 patients were placed in a control group. The long-term follow-up was extended to nine years after enrollment of the last patient.

The primary endpoint of the study was RFS, and secondary endpoints included cancer-specific survival (CSS) and overall survival (OS). A prospective study was also initiated to determine post-treatment changes in immune cells in the peripheral blood of seven patients who received repeated transfer of CIK cells through flow cytometry after curative treatment for HCC.

The median follow-up of the RCT’s extended follow-up was 115.7 months. During the extended follow-up, the CIK group experienced a significantly prolonged RFS (median, 43.5 vs 27.4 months; HR, 0.74; 95% CI, 0.55-0.99; P=.045) and CSS (median, unreached; HR, 0.49; 95% CI, 0.25-0.95; P=0.04) compared with patients in the control group.

The use of adjuvant CIK cell therapy reduced the risk of overall death by 30%, but it did not reach statistical significance (median, unreached; HR, 0.70; 95% CI, 0.44-1.11; P=0.1). A preliminary analysis of peripheral blood immune cells showed that the CIK cell treatment had a tendency to increase the frequencies of CD8+ and CD4+ classical memory cells.

This extended 9-year follow-up of patients who received curative treatment for HCC has shown that adjuvant CIK cell treatment can provide significantly enhanced RFS and CSS. Patients who received CIK treatment had a consistent trend of improved OS, and the sustained off-treatment antitumor efficacy of CIK cell treatment may be linked to the increase in memory T-cell populations.

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