Abstract

Purpose

To compare safety and efficacy of combined therapy with conventional transarterial chemoembolization (cTACE)+microwave ablation (MWA) versus only TACE or MWA for treatment of hepatocellular carcinoma (HCC) >3–<5 cm.

Methods

This randomized controlled trial (NCT04721470) screened 278 patients with HCC >3–<5 cm. Patients were randomized into three groups: 90 underwent TACE (Group 1); 95 underwent MWA (Group 2); and 93 underwent combined therapy (Group 3). Patients were followed-up with contrast-enhanced CT or MRI. Images were evaluated and compared for treatment response and adverse events based on modified response evaluation criteria in solid tumor. Serum alpha-fetoprotein (AFP) concentration was measured at baseline and during every follow-up visit.

Results

Final analysis included 265 patients (154 men, 111 women; mean age = 54.5 ± 11.8 years; range = 38–76 years). Complete response was achieved by 86.5% of patients who received combined therapy compared with 54.8% with only TACE and 56.5% with only MWA (p = 0.0002). The recurrence rate after 12 months was significantly lower in Group 3 (22.47%) than Groups 1 (60.7%) and 2 (51.1%) (p = 0.0001). The overall survival rate (three years after therapy) was significantly higher in Group 3 (69.6%) than Groups 1 (54.7%) and 2 (54.3%) (p = 0.02). The mean progression-free survival was significantly higher in Group 3 than groups 1 and 2 (p < 0.001). A decrease in AFP concentration was seen in 75%, 63%, and 48% patients of Group 3, 2, and 1, respectively.

Conclusions

Combined therapy with cTACE + MWA is safe, well-tolerated, and more effective than TACE or MWA alone for treatment of HCC >3–<5 cm.

中文翻译：

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常规肝动脉化疗栓塞（cTACE）和微波消融（MWA）联合治疗> 3– <5 cm肝细胞癌

摘要

目的

比较传统经动脉化学栓塞（cTACE）+微波消融（MWA）与仅使用TACE或MWA联合治疗肝细胞癌（HCC）> 3– <5 cm的安全性和有效性。

方法

这项随机对照试验（NCT04721470）对278例HCC> 3– <5 cm的患者进行了筛查。将患者随机分为三组：90例行TACE治疗（第1组）；95名进行了MWA（第2组）；93例接受了联合治疗（第3组）。对患者进行对比增强的CT或MRI随访。根据实体瘤中经过修改的反应评估标准，评估并比较图像的治疗反应和不良事件。在基线和每次随访期间测量血清甲胎蛋白（AFP）浓度。

结果

最终分析包括265位患者（154位男性，111位女性；平均年龄= 54.5±11.8岁；范围= 38-76岁）。接受联合治疗的患者中有86.5％的患者获得了完全缓解，而仅使用TACE的患者为54.8％，仅接受MWA的患者为56.5％（p  = 0.0002）。第3组（12.47％）在12个月后的复发率显着低于第1组（60.7％）和第2组（51.1％）（p  = 0.0001）。第三组（69.6％）的总生存率（治疗后三年）明显高于第一组（54.7％）和第二组（54.3％）（p  = 0.02）。第3组的平均无进展生存期明显高于第1组和第2组（p <0.001）。组3、2和1的患者中AFP浓度分别下降了75％，63％和48％。

结论

与单独的TACE或MWA联合使用cTACE + MWA的联合治疗安全性高，耐受性好，并且比单独使用TACE或MWA更有效。