Abstract

BackgroundSeveral randomized controlled trials have shown that adjuvant immunotherapy with autologous cytokine-induced killer (CIK) cells prolongs recurrence-free survival (RFS) after curative treatment for hepatocellular carcinoma (HCC). We investigated the efficacy of adjuvant immunotherapy with activated CIK cells in real-world clinical practice.MethodsA total of 59 patients who had undergone curative surgical resection or radiofrequency ablation for stage I or II HCC, and subsequently received adjuvant CIK cell immunotherapy at two large-volume centers in Korea were retrospectively included. Propensity score matching with a 1:1 ratio was conducted to avoid possible bias, and 59 pairs of matched control subjects were also generated. The primary endpoint was RFS and the secondary endpoints were overall survival and safety.ResultsThe median follow-up duration was 28.0 months (interquartile range, 22.9–42.3 months). In a univariable analysis, the immunotherapy group showed significantly longer RFS than the control group (hazard ratio [HR], 0.42; 95% CI, 0.22–0.80; log-rank P = 0.006). The median RFS in the control group was 29.8 months, and the immunotherapy group did not reach a median RFS. A multivariable Cox proportional hazard analysis showed that immunotherapy was an independent predictor for HCC recurrence (adjusted HR, 0.38; 95% CI, 0.20–0.73; P = 0.004). The overall incidence of adverse events in the immunotherapy group was 16/59 (27.1%) and no patient experienced a grade 3 or 4 adverse event.ConclusionsThe adjuvant immunotherapy with autologous CIK cells after curative treatment safely prolonged the RFS of HCC patients in a real-world setting.

Highlights

  • Several randomized controlled trials have shown that adjuvant immunotherapy with autologous cytokine-induced killer (CIK) cells prolongs recurrence-free survival (RFS) after curative treatment for hepatocellular carcinoma (HCC)

  • We randomly selected 236 of those patients, which was 4-fold the number of patients in the immunotherapy group, by using a propensity score (PS) matching model consisting of two variables

  • We performed a 1: 1 PS matching for those 158 patients and 59 patients in the immunotherapy group

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Summary

Introduction

Several randomized controlled trials have shown that adjuvant immunotherapy with autologous cytokine-induced killer (CIK) cells prolongs recurrence-free survival (RFS) after curative treatment for hepatocellular carcinoma (HCC). Hepatocellular carcinoma (HCC) is an aggressive cancer that most often occurs in patients with chronic liver disease and cirrhosis. The use of active surveillance programs for these high-risk patients can detect HCC at an early stage and improve survival [1,2,3]. Surgical liver resection and radiofrequency ablation (RFA) are the most frequently used curative treatment options for early stage HCC patients with preserved liver function [4, 5]. Approximately 70% of HCC patients who undergo surgical resection or RFA will experience recurrence within 5 years [6]. The effective adjuvant therapies that can be applied after curative treatments to reduce recurrence are urgently needed

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