Cai Jianqiang, Zhao Jianjun, Liu Defang, Xie Huangfan, Qi Hailong, Ma Junfan, Sun Zhongjie, Zhao Hong
Department of Hepatobiliary Surgery, State Key Laboratory of Molecular Oncology, National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, China.
Department of New Drug Registration, Hebei Immune Cell Application Engineering Research Center/Baoding Newish Technology Co., LTD/Newish Technology (Beijing) Co., LTD, Beijing, China.
Front Oncol. 2021 Dec 3;11:781029. doi: 10.3389/fonc.2021.781029. eCollection 2021.
Postoperative adjuvant transcatheter arterial chemoembolization (TACE) following curative hepatectomy has been reported to improve the clinical outcomes of hepatocellular carcinoma (HCC) patients with microvascular invasion (MVI), but more endeavors are required to achieve greater clinical benefit. Central memory T-cell (Tcm) self-transfusion has shown superior antitumor activity in several preclinical studies; however, clinical studies are rare. The aim of this study was to evaluate the clinical benefit and safety of combination treatment with Tcm self-transfusion and TACE as adjuvant treatment in HCC patients with MVI after curative hepatectomy.
From October 2016 to September 2018, primary HCC patients with histologically confirmed MVI who underwent curative hepatectomy at the Cancer Hospital of the Chinese Academy of Medical Sciences were recruited for this study. The patients were divided into a Tcm group (combined Tcm self-transfusion with TACE treatment) or a control group (TACE treatment alone) according to their willingness. The recurrence-free survival (RFS), quality-of-life (QOL) score, and adverse events of each patient were recorded within 2 years.
A total of 52 patients were enrolled, and 48 were eligible for the final data analysis. The median follow-up time was 20.5 months (95% CI: 17.05-22.55 months). The median RFS time was 9.5 months in the control group; the cutoff date was not reached in the Tcm group (when the follow-up duration was 12 months, = 0.049, HR = 0.40; 95% CI: 0.16-0.99). Compared with the control group, 1- and 2-year RFS rates were higher in the Tcm group (72.0% 46.4% and 58.18% 39.14%, respectively). Multivariate analysis did not indicate that Tcm treatment was an independent prognostic factor associated with HCC recurrence ( = 0.107, HR = 2.312; 95% CI: 0.835-6.400), which might be due to the small sample size of this study. Nevertheless, Tcm treatment effectively improved a reduced QOL due to HCC and liver function injury. Finally, the safety profile of Tcm treatment in this study was good, without any serious adverse events.
This pilot study showed that Tcm self-transfusion combined with TACE treatment might be a beneficial adjuvant therapy with good safety for primary HCC patients with MVI after curative hepatectomy.
NCT03575806.
据报道，根治性肝切除术后行辅助性经动脉化疗栓塞术（TACE）可改善伴有微血管侵犯（MVI）的肝细胞癌（HCC）患者的临床结局，但仍需更多努力以获得更大的临床益处。在多项临床前研究中，中枢记忆T细胞（Tcm）自体输血已显示出卓越的抗肿瘤活性；然而，临床研究却很罕见。本研究的目的是评估Tcm自体输血联合TACE作为根治性肝切除术后伴有MVI的HCC患者辅助治疗的临床益处及安全性。
2016年10月至2018年9月，招募在中国医学科学院肿瘤医院接受根治性肝切除且经组织学证实为MVI的原发性HCC患者参与本研究。根据患者意愿将其分为Tcm组（Tcm自体输血联合TACE治疗）或对照组（单纯TACE治疗）。记录每位患者2年内的无复发生存期（RFS）、生活质量（QOL）评分及不良事件。
共纳入52例患者，48例符合最终数据分析要求。中位随访时间为20.5个月（95%CI：17.05 - 22.55个月）。对照组的中位RFS时间为9.5个月；Tcm组未达到截止日期（随访12个月时，P = 0.049，HR = 0.40；95%CI：0.16 - 0.99）。与对照组相比，Tcm组1年和2年的RFS率更高（分别为72.0%对46.4%和58.18%对39.14%）。多因素分析未表明Tcm治疗是与HCC复发相关的独立预后因素（P = 0.107，HR = 2.312；95%CI：0.835 - 6.400），这可能是由于本研究样本量较小。尽管如此，Tcm治疗有效改善了因HCC和肝功能损伤导致的生活质量下降。最后，本研究中Tcm治疗的安全性良好，未出现任何严重不良事件。
这项初步研究表明，Tcm自体输血联合TACE治疗可能是根治性肝切除术后伴有MVI的原发性HCC患者一种有益的辅助治疗方法，且安全性良好。
NCT03575806。
