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2016年6月3-7日,一年一度的美国临床肿瘤学会(American Society of Clinical Oncology,ASCO)年会在芝加哥举办。6月4日上午的消化系统(非结直肠)肿瘤壁报专场上,中国人民解放军总医院的于杰教授呈现了一项摘要号为4068的中国研究,该研究将水冷微波和射频消融治疗早期肝细胞癌进行比较,是一项III期随机对照试验,同时提交了6年随访结果,医脉通整理如下:
根据随机对照试验(RCT)的要求,为了找到一种微创热消融的最佳方法,将水冷微波消融(MWA)与射频消融(RFA)在早期<5cm肝细胞癌(HCC)上的疗效进行比较。
从2008年10月到2015年6月,403例经活检证实的HCC患者病例被纳入一项RCT研究,203例(265个结节)病例接受超声引导的经皮MWA治疗,200例(251个结节)病例接受RFA治疗。而后,患者接受对比增强影像技术随访包括超声造影,磁共振成像或者计算机断层扫描来前瞻性评估治疗反应,包括技术有效率(TE),局部肿瘤进展(LTP),肝内转移,肝外转移,并发症,无疾病生存期(DFS)和总生存期(OS)。应用Kaplan–Meier方法对生存期进行分析。该项研究已经在Clinical-Trials.gov注册,注册编号为NCT02539212。
随访时间是35.2(范围2.0-81.9)个月。MWA需要较少的涂敷器数量,消融次数,穿刺次数,消融持续时间和费用(P<0.05)。MWA和RFA的TE率分别为99.6%(264/265)和98.8%(248/251)。1-,3-,5-年的LTP分别为:MWA,1.1%,4.3%,11.4% vs RFA,2.1%,5.8%,19.7%(P=0.11)。1-,3-,5-年的OS分别为:MWA,96.4%,81.9%,67.3% vs RFA,95.9%,81.4%,72.7%(P=0.91)。在这两组之间,5年肝内转移(P=0.30)和肝外转移率(P=0.12)没有差异。MWA(3.4%)和RFA(2.5%)之间的主要并发症也没有差异(P=0.59)。
水冷微波消融(MWA)和射频消融(RFA)均是早期肝细胞癌的合适选择。MWA占有消融持续时间较少,穿刺次数较少,治疗次数较少以及费用较低的优势。因此,水冷微波消融似乎是HCC治疗的一种安全有效的策略。临床试验信息:NCT02539212。
会议专题》》》2016年ASCO年会专题报道
原文摘要:
Comparison of cooled-probe microwave and radiofrequency ablation treatment in incipient hepatocellular carcinoma: A phase III randomized controlled trial with 6-year follow-up.(Abstract4068)
Authors: Jie Yu, Ping Liang, Xiao-ling Yu,et al
Session Type:Poster Session
Background: According to randomized controlled trial (RCT) requirement, the therapeutic effectiveness of cooled-probe microwave ablation (MWA) versus radiofrequency ablation (RFA) on early-stage < 5cm hepatocellular carcinoma (HCC) was investigated to find a better approach for minimally invasive thermal ablation.
Methods: From October 2008 to June 2015, 403 cases of biopsy-proved HCC patients were involved in a RCT study, 203 (265 nodules) cases were treated with ultrasound guided percutaneously MWA and 200 (251 nodules) cases were treated with RFA. The patients were then followed up with contrast enhanced imaging including contrast enhanced ultrasound, magnetic resonance imaging or computed tomography to evaluate treatment response prospectively, including technique effectiveness (TE), local tumor progression (LTP), intrahepatic metastases, extrahepatic metastases, complications, disease free survival(DFS) and overall survival(OS). Survival was analysed using the Kaplan–Meier method. The study has been registered in Clinical-Trials.gov and the identifier number is NCT02539212.
Results: The follow-up period was 35.2 (range 2.0-81.9) months. MWA needed less applicator number, ablation session, puncture number, ablation duration and expense (P< 0.05). The TE rates were 99.6% (264/265) in MWA and 98.8% (248/251) in RFA. The 1-, 3-, 5-year LTP were 1.1%, 4.3%, 11.4% for MWA versus 2.1%, 5.8%, 19.7% for RFA, respectively(P= 0.11). The 1-, 3-, 5-year OS were 96.4%, 81.9% and 67.3% for MWA and 95.9%, 81.4% and 72.7% for RFA, respectively (P = 0.91). There was no difference in 5-year intrahepatic metastatic (P= 0.30) and extrahepatic metastatic rates(P= 0.12) between two groups. There was also no difference in major complications between MWA(3.4%) and RFA (2.5%) (P= 0.59).
Conclusions: Both MWA and RFA are suitable options for early-stage HCC. MWA shared the advantages of less ablation duration, puncture, session and expense. Therefore, MWA seems a safe and promising treatment of HCC. Clinical trial information: NCT02539212
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