A Transarterial Chemoembolization of Balloon-Occluded Alternate Infusions of Cisplatin and Gelatin Particles for Hepatocellular Carcinoma: A Phase I/II Multicenter Prospective Study of Safety and Efficacy
A Transarterial Chemoembolization of Balloon-Occluded Alternate Infusions of Cisplatin and Gelatin Particles for Hepatocellular Carcinoma: A Phase I/II Multicenter Prospective Study of Safety and Efficacy
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DOI：
10.1016/j.jvir.2021.10.015
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发表时间：
2022-01-29
影响因子：
2.9
通讯作者：
Nakajima, Takahito
中科院分区：
文献类型：
--
作者：
Hoshiai, Sodai;Irie, Toshiyuki;Nakajima, Takahito
目的：评价一种新开发的经动脉化疗栓塞术（HCC）中顺铂和明胶颗粒交替灌注球囊闭塞技术的安全性和有效性，并评价手术后的肝损害。材料和方法：43例HCC患者来自4个医疗中心，参加了这项多中心前瞻性研究。其中，41例患者在球囊闭塞交替灌注经动脉化疗栓塞后观察6个月。主要终点是手术的安全性，次要终点是治疗后2个月HCC的客观缓解率（ORR）。结果如下：3例患者发生不良事件，包括1例面部肿胀和皮疹、腹腔动脉夹层和轻度门静脉血栓。未发现重大不良事件。2例（5.3%）患者的Child-Pugh分级从A级退化至B级。球囊闭塞交替输注经动脉化疗栓塞治疗的完全缓解率（CR）为22.0%，ORR为73.2%（95%置信区间[CI]，57.9%-84.4%）。在一项对23例超过7项标准的HCC患者的回顾性分析中，球囊闭塞交替灌注经动脉化疗栓塞的CR率和ORR分别为21.7%和82.6%（95%CI，62.3%-93.6%）。结论：经动脉化疗栓塞栓塞术可安全有效地实现高ORR，同时保留肝功能。
Purpose: To evaluate the safety and efficacy of a newly developed technique of balloon-occluded alternate infusions of cisplatin and gelatin particles in transarterial chemoembolization in hepatocellular carcinoma (HCC) and to evaluate the liver damage following the procedure. Materials and Methods: Forty-three patients with HCC from 4 medical centers were enrolled in this multicenter prospective study. Of these, 41 patients were observed for 6 months following balloon-occluded alternate infusion transarterial chemoembolization. The primary endpoint was the safety of the procedure, and the secondary endpoint was the objective response rate (ORR) of the HCCs at 2 months following treatment. Results: Three patients experienced adverse events, including 1 patient with facial swelling and skin rash, dissection of the celiac artery, and bland portal vein thrombus. No major adverse events were identified. Two (5.3%) patients regressed from a Child-Pugh classification of A to B. The balloon-occluded alternate infusion transarterial chemoembolization treatment achieved a 22.0% complete response (CR) rate and a 73.2% ORR (95% confidence interval [CI], 57.9%-84.4%). In a retrospective analysis of 23 patients with HCCs above the up-to-7 criteria, the CR rate and ORR of the balloon-occluded alternate infusion transarterial chemoembolization were 21.7% and 82.6% (95% CI, 62.3%-93.6%), respectively. Conclusions: Balloon-occluded alternate infusion transarterial chemoembolization is safe and effective for achieving a high ORR while preserving liver function.