Wang Junxiao, Xue Yaoqin, Liu Rui, Wen Zhenyu, Ma Zhenhu, Yang Xiang, Yu Lingxiang, Yang Bin, Xie Hui
Aerospace Medical Center, Aerospace Center Hospital, Beijing, China.
Senior Department of Oncology, Fifth Medical Center of Chinese PLA General Hospital, Beijing, China.
Front Bioeng Biotechnol. 2023 Jan 12;10:1112500. doi: 10.3389/fbioe.2022.1112500. eCollection 2022.
DEB-TACE with irinotecan and C-TACE were compared with regards to safety and efficacy for the therapy of intrahepatic cholangiocarcinoma (ICC). Institutional Review Board approved our trial and we registered it in the Chinese Clinical Trial Registry (ChiCTR1900022856). Forty patients with biopsy-confirmed ICC were randomised to either receive DEB-TACE or C-TACE treatment with 20 patients in each treatment arm. The primary endpoints objective response rate (ORR) and progression free survival (PFS) using the mRECIST to evaluate the tumours. The secondary endpoints were overall survival (OS) and safety. The chi-square was used to analyse the data. The Kaplan-Meier method and Cox analysis were used to evaluate the survival data. ORR (70% in DEB-TACE group vs. 20% in C-TACE, = .001) at 1 month after therapy, ORR (50% vs. 15%, = .018) at 3 months and DCR (70% vs. 30%, = .011) at 6 months, while no difference was found in other groups. (all > .05) The median PFS with DEB-TACE was longer than that with C-TACE (8.0 months vs. 3.0 months) ( = .042). Although the median OS was longer with DEB-TACE than with C-TACE (11.5 months vs. 9.0 months), the difference was not statistically significant ( = .280). The Cox regression analysis demonstrated that TACE sessions ( = .017) and low CA125 levels ( = .001) were independent favourable prognostic factors. The most frequent adverse event was elevated transaminase levels (20/20 in DEB-TACE group vs. 15/20 in C-TACE group) ( = .047). Our prospective study suggested better ORR and PFS with DEB-TACE with irinotecan as compared to C-TACE with irinotecan in the treatment of unresectable ICC.
比较了载药微球经动脉化疗栓塞术（DEB-TACE）联合伊立替康与传统经动脉化疗栓塞术（C-TACE）治疗肝内胆管癌（ICC）的安全性和疗效。机构审查委员会批准了我们的试验，并在中国临床试验注册中心注册（ChiCTR1900022856）。40例经活检确诊的ICC患者被随机分为两组，每组20例，分别接受DEB-TACE或C-TACE治疗。主要终点为使用改良实体瘤疗效评价标准（mRECIST）评估肿瘤的客观缓解率（ORR）和无进展生存期（PFS）。次要终点为总生存期（OS）和安全性。采用卡方检验分析数据。采用Kaplan-Meier法和Cox分析评估生存数据。治疗后1个月时的ORR（DEB-TACE组为70%，C-TACE组为20%，P = 0.001），3个月时的ORR（50%对15%，P = 0.018）以及6个月时的疾病控制率（DCR）（70%对30%，P = 0.011），而其他组未发现差异（均P > 0.05）。DEB-TACE组的中位PFS长于C-TACE组（8.0个月对3.0个月）（P = 0.042）。虽然DEB-TACE组的中位OS长于C-TACE组（11.5个月对9.0个月），但差异无统计学意义（P = 0.280）。Cox回归分析表明，TACE疗程（P = 0.017）和低CA125水平（P = 0.001）是独立的有利预后因素。最常见的不良事件是转氨酶水平升高（DEB-TACE组20/20例，C-TACE组15/20例）（P = 0.047）。我们的前瞻性研究表明，在治疗不可切除的ICC时，与伊立替康联合C-TACE相比，伊立替康联合DEB-TACE具有更好的ORR和PFS。
