细胞因子诱导的杀伤细胞免疫疗法辅助治疗肝细胞癌：真实世界数据的倾向性评分匹配分析。
Adjuvant cytokine-induced killer cell immunotherapy for hepatocellular carcinoma: a propensity score-matched analysis of real-world data.
机构信息
Department of Internal Medicine and Liver Research Institute, Seoul National University College of Medicine, Seoul, South Korea.
Department of Internal Medicine, Busan Paik Hospital, Inje University College of Medicine, Busan, South Korea.
出版信息
BMC Cancer. 2019 May 31;19(1):523. doi: 10.1186/s12885-019-5740-z.
BACKGROUND
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 investigated the efficacy of adjuvant immunotherapy with activated CIK cells in real-world clinical practice.
METHODS
A 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.
RESULTS
The 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.
CONCLUSIONS
The adjuvant immunotherapy with autologous CIK cells after curative treatment safely prolonged the RFS of HCC patients in a real-world setting.
背景
几项随机对照试验表明，辅助免疫疗法用自体细胞因子诱导的杀伤（CIK）细胞延长根治性治疗后肝细胞癌（HCC）的无复发生存（RFS）。我们研究了在真实临床实践中辅助用激活的 CIK 细胞免疫疗法的疗效。
方法
总共纳入 59 例接受根治性手术切除或射频消融术治疗 I 期或 II 期 HCC 后，在韩国的两个大容量中心接受辅助 CIK 细胞免疫治疗的患者。采用 1:1 比例的倾向评分匹配来避免可能的偏倚，并生成了 59 对匹配的对照组。主要终点是 RFS，次要终点是总生存和安全性。
结果
中位随访时间为 28.0 个月（四分位距，22.9-42.3 个月）。单变量分析显示，免疫治疗组的 RFS 明显长于对照组（风险比 [HR]，0.42；95%CI，0.22-0.80；对数秩 P=0.006）。对照组的中位 RFS 为 29.8 个月，免疫治疗组未达到中位 RFS。多变量 Cox 比例风险分析显示，免疫治疗是 HCC 复发的独立预测因素（调整 HR，0.38；95%CI，0.20-0.73；P=0.004）。免疫治疗组总的不良事件发生率为 16/59（27.1%），没有患者发生 3 级或 4 级不良事件。
结论
在真实环境中，辅助用自体 CIK 细胞免疫疗法治疗根治性治疗后安全地延长了 HCC 患者的 RFS。
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