经皮冷冻探针微波与早期肝细胞癌射频消融术：Ⅲ期随机对

StephenW

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                      Percutaneous cooled-probe microwave versus radiofrequency ablation in early-stage hepatocellular carcinoma: a phase III randomised controlled trial
         
  
   
                                      

• Jie Yu1,
• Xiao-ling Yu1,
• Zhi-yu Han1,
• Zhi-gang Cheng1,
• Fang-yi Liu1,
• Hong-yan Zhai2,
• Meng-juan Mu1,
• Yan-mei Liu1,
• Ping Liang1
  

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                http://dx.doi.org/10.1136/gutjnl-2016-312629
  
   
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We read with interest the article by Bruix et al1 on currently available treatment options for hepatocellular carcinoma (HCC). Radiofrequency ablation (RFA) is now the first-line technique for HCC ablation. RFA produces tumour necrosis in situ through temperature modification. Compared with RFA, microwave ablation (MWA) is one relatively recent advancement of thermoablative technology, which shows multiple theoretical advantages over RFA.2–4 We wish to report the results of a phase III randomised controlled trial (RCT) by comparing ultrasound-guided percutaneous cooled-probe MWA and RFA in ≤5 cm HCC (NCT 02539212).

From October 2008 to June 2015, 203 (265 nodules) subjects were randomised to MWA and 200 (251 nodules) were randomised to RFA. The indications were as follows: tumour size ≤5 cm in diameter, tumour number ≤3, Child–Pugh class A or B classification, no evidence of extrahepatic metastasis, vein or bile duct tumour embolus, lesions visible on ultrasound with an acceptable puncture path, an Eastern Cooperative Oncology Group performance status of 0–1, and no any other anticancer treatment previously. All the patients were percutaneously treated by a cooled-shaft microwave system (KY-2000, Kangyou Medical, China) or radiofrequency system (WB991029, CelonLab Power, Germany).

         

The median follow-up period was 35.2 (2.0–81.9) months. The demographics and preablation liver function tests of both groups were similar. For the MWA group, the tumour size was 2.7±1.0 (0.7–5.0) cm, with 28.3% (75/265) of nodules >3.0 cm and 50.6% (134/265) of them were in risky locations (adjacent to large vessel, gastroenterology tract, diaphragm, or gallbladder). For the RFA group, the tumour size was 2.6±1.0 (0.9–5.0) cm, with 30.7% (77/251) of nodules >3.0 cm, and 50.2% (126/251) of them in risky location. MWA needed significantly fewer sessions, applicator puncture and ablation durations, with lower hospitalisation cost than that for RFA (table 1).

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Table 1

Patients' treatment parameters between MWA and RFA groups

The technique effectiveness was 99.6% (264/265) in tumours treated by MWA and 98.8% (248/251) by RFA (p=0.95). The 1-year, 3-year and 5-year local tumour progression rates were 1.1%, 4.3%, 11.4% for MWA versus 2.1%, 5.8%, 19.7% for RFA (p=0.11), which also showed no significant differences in subsets of tumours (including ≤3.0 cm, 3.1–5.0 cm tumours and tumours in risky locations). The 1-year, 3-year and 5-year intrahepatic metastatic rates were 3.5%, 22.9% and 58.7% for MWA versus 3.8%, 23.2% and 67.8% for RFA (p=0.30). The 1-year, 3-year and 5-year extrahepatic metastatic rates were 1.6%, 5.9% and 13.2% for MWA versus 2.2%, 11.2% and 19.3% for RFA (p=0.12). The 1-year, 3-year, 5-year overall survival rates were 96.4%, 81.9% and 67.3% for MWA versus 95.9%, 81.4% and 72.7% for RFA (p=0.91), and the 1-year, 3-year, 5-year disease free survival rates were 94.0%, 70.6% and 36.7% for MWA versus 93.8%, 66.0% and 24.1% for RFA (p=0.07) (figure 1). The major complication rates were 3.4% (7/203) for MWA and 2.5% (5/200) for RFA (p=0.59), including needle seeding, GI bleeding and bulk pleural effusion.

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Figure 1

Survival comparison between microwave ablation (MWA) and radiofrequency ablation (RFA) of early-stage hepatocellular carcinoma (HCC). (A) Overall survival curves after MWA and RFA of HCC. There is no significant difference between two treatments (P=0.91). (B) Disease free survival curves after MWA and RFA of HCC. There is no significant difference between two treatments (P=0.07).

The comparison between MWA and RFA in HCC has being paid a great deal of attention in recent years, but only with one RCT in 2002 and very limited prospective studies.5–8 Though our results showed favourable long-term prognosis for both modalities, MWA showed some advantages due to higher thermal efficiency as follows. First, even if without statistic difference, MWA showed better tumour inactivation ability over RFA for 3–5 cm tumours (6.7% vs 13.0%) and tumours adjacent to vessels (4.3% vs 7.7%) and gallbladder (0% vs 7.1%). Second, MWA needed a fewer number of ablation sessions and application puncture, which contributed to less invasion and costs. Third, with MWA, it was possible to decrease the time required for ablation by 60%, which provided patients unable to tolerate intravenous anaesthesia due to comorbidities a chance to undergo treatment.

Findings in this large-sample RCT study suggest that both MWA and RFA are suitable options for early-stage HCC, with better prospects for MWA due to its higher thermal efficiency.

Acknowledgments

This work was supported by two grants 81401436 and 81430039 from the National Scientific Foundation Committee of China.

StephenW

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经皮冷冻探针微波与早期肝细胞癌射频消融术：Ⅲ期随机对照试验

    杰玉1，肖晓玲1，志瑜韩1，志刚刚1，方芳义刘1，洪艳燕2，孟娟木1，严美美刘平1平良1

http://dx.doi.org/10.1136/gutjnl-2016-312629
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我们感兴趣地阅读了Bruix等人1关于肝细胞癌（HCC）的现有治疗方案的文章。射频消融（RFA）现在是HCC消融的一线技术。 RFA通过温度改变原位产生肿瘤坏死。与RFA相比，微波消融（MWA）是一种相对较新进展的热烧蚀技术，与RFA相比具有多个理论优势.2-4我们希望通过比较超声引导来报告III期随机对照试验（RCT）的结果经皮冷却探针MWA和RFA在≤5cm HCC（NCT 02539212）。

从2008年10月至2015年6月，将203例（265例结节）受试者随机分配至MWA，将200例（251例结节）随机分配至RFA。适应证如下：肿瘤直径≤5厘米，肿瘤数≤3，Child-Pugh A级或B级分类，无肝外转移，静脉或胆管肿瘤栓塞的迹象，超声可见的穿刺路径可见病变，东方肿瘤协会组织表现状况为0-1，以前没有任何其他抗癌治疗。所有患者均通过冷轴微波系统（KY-2000，Kangyou Medical，China）或射频系统（WB991029，CelonLab Power，Germany）经皮处理。

中位随访期为35.2（2.0-81.9）个月。两组患者的人口统计学和预检肝功能检查相似。对于MWA组，肿瘤大小为2.7±1.0（0.7-5.0）cm，结节28.3％（75/265）> 3.0cm，其中50.6％（134/265）处于危险位置血管，胃肠道，隔膜或胆囊）。对于RFA组，肿瘤大小为2.6±1.0（0.9-5.0）cm，其中30.7％（77/251）的结节> 3.0cm，其中50.2％（126/251）在危险位置。 MWA需要显着减少会话，敷贴器穿刺和消融持续时间，住院费用低于RFA（表1）。

表格1

MWA和RFA组之间的患者治疗参数

在MWA治疗的肿瘤中，技术有效性为99.6％（264/265），RFA为98.8％（248/251）（p = 0.95）。 1年，3年和5年局部肿瘤进展率分别为1.1％，4.3％，11.4％，分别为2.1％，5.8％，19.7％（p = 0.11），差异无统计学意义在肿瘤（包括≤3.0厘米，3.1-5.0厘米肿瘤和危险位置的肿瘤）的子集中。 1年，3年和5年肝内转移率分别为3.5％，22.9％和58.7％，分别为3.8％，23.2％和67.8％（p = 0.30）。 1年，3年和5年肝外转移率分别为1.6％，5.9％和13.2％，分别为2.2％，11.2％和19.3％（p = 0.12）。 1年，3年，5年总体生存率分别为96.4％，81.9％和67.3％，RFA为95.9％，81.4％和72.7％（p = 0.91），1年，3年 - 年，MWA的5年无病生存率分别为94.0％，70.6％和36.7％，而RFA为93.8％，66.0％和24.1％（p = 0.07）（图1）。主要并发症发生率分别为3.4％（7/203）和2.5％（5/200）RFA（p = 0.59），包括针刺，GI出血和散发性胸腔积液。
图1
早期肝细胞癌（HCC）的微波消融（MWA）与射频消融（RFA）的生存比较。 （A）肝癌的MWA和RFA后总生存曲线。两种治疗方法差异无统计学意义（P = 0.91）。 （B）肝癌后MWA和RFA后无病生存曲线。两种处理间差异无统计学意义（P = 0.07）。
近年来，肝细胞癌与RFA的比较近年来受到了极大的关注，但2002年仅有一例RCT，前瞻性研究非常有限.5-8尽管我们的研究结果显示两种方式的良好的长期预后，MWA由于更高的热效率如下所示，具有一些优点。首先，即使没有统计学差异，MWA对3-5cm肿瘤（6.7％对13.0％）和与血管相邻的肿瘤（4.3​​％vs 7.7％）和胆囊（0％vs 7.1％）显示比RFA更好的肿瘤灭活能力， 。其次，MWA需要更少的消融会话和应用穿刺，这有助于减少入侵和成本。第三，使用MWA，可以将消融所需的时间减少60％，这使得患者由于合并症有机会接受治疗而无法耐受静脉麻醉。

这一大样本RCT研究结果表明，MWA和RFA都是早期HCC的合适选择，由于其更高的热效率，MWA的前景更好。

StephenW

http://gut.bmj.com/content/66/6/1172?etoc