Riemsma Robert P, Bala Malgorzata M, Wolff Robert, Kleijnen Jos
Kleijnen Systematic Reviews Ltd, York,UK.
Cochrane Database Syst Rev. 2013 May 31(5):CD008717. doi: 10.1002/14651858.CD008717.pub2.
Primary liver tumours and liver metastases from colorectal carcinoma are the two most common malignant tumours to affect the liver. The liver is second only to the lymph nodes as the most common site for metastatic disease. More than half of the patients with metastatic liver disease will die from metastatic complications. Percutaneous ethanol injection (PEI) causes dehydration and necrosis of tumour cells accompanied by small vessel thrombosis, leading to tumour ischaemia and destruction.
To study the beneficial and harmful effects of percutaneous ethanol injection compared with no intervention, other ablation methods, or systemic treatments in patients with liver metastases.
We searched the Cochrane Hepato-Biliary Group Controlled Trials Register, Cochrane Central Register of Controlled Trials (CENTRAL) in The Cochrane Library, MEDLINE, EMBASE, Science Citation Index Expanded, LILACS, and CINAHL up to December 2012.
We included all randomised clinical trials assessing the beneficial and harmful effects of percutaneous ethanol injection versus no intervention, other ablation methods, or systemic treatments in patients with liver metastases.
We extracted the relevant information on participant characteristics, interventions, study outcome measures, and data on the outcome measures for our review, as well as information on the design and methodology of the studies. Quality assessment of the trials fulfilling the inclusion criteria and data extraction from the trials retrieved for final evaluation were done by one author and checked by a second author.
One randomised clinical trial was included, comparing transcatheter arterial chemoembolisation (TACE) + percutaneous intratumour ethanol injection (PEI) versus TACE alone. Forty-eight patients with liver metastases were included; 25 received the intervention with PEI and 23 received TACE alone.Mortality data were not reported. The trial reported the survival data after one, two, and three years. In the TACE + PEI group, 92%, 80%, and 64% of the patients survived after 1, 2, and 3 years respectively; in the TACE group, 78.3%, 65.2%, and 47.8% of the patients survived after 1, 2, and 3 years respectively. The hazard ratio was 0.57 (95% CI 0.19 to 1.67). The local recurrence was 16% in the TACE + PEI group and 39.1% in the TACE group, resulting in a relative risk (RR) of 0.41 (95% CI 0.15 to 1.07). Forty-five tumours (66.2%) out of 68 tumours in total shrunk by at least 25% in the TACE + PEI group versus 31 tumours (48.4%) out of 64 tumours in total in the TACE group (RR 2.08; 95% CI 1.03 to 4.2). The authors reported some adverse events, but with very few details.
AUTHORS' CONCLUSIONS: On the basis of one small randomised trial, it can be concluded that addition of PEI to TACE, as compared with TACE alone, in patients with liver metastases seems to bring no clear benefit in terms of survival and local recurrence. The size of the tumour necrosis was larger in the combined treatment group. No intervention-related mortality or major complications were reported. More trials are needed.
原发性肝癌和结直肠癌肝转移是影响肝脏的两种最常见的恶性肿瘤。肝脏是仅次于淋巴结的最常见转移疾病部位。超过一半的肝转移患者将死于转移并发症。经皮乙醇注射(PEI)可导致肿瘤细胞脱水和坏死,并伴有小血管血栓形成,从而导致肿瘤缺血和破坏。
研究与不干预、其他消融方法或全身治疗相比,经皮乙醇注射对肝转移患者的有益和有害影响。
我们检索了Cochrane肝胆组对照试验注册库、Cochrane图书馆中的Cochrane中央对照试验注册库(CENTRAL)、MEDLINE、EMBASE、科学引文索引扩展版、LILACS和CINAHL,检索截至2012年12月的文献。
我们纳入了所有评估经皮乙醇注射与不干预、其他消融方法或全身治疗相比,对肝转移患者的有益和有害影响的随机临床试验。
我们提取了有关参与者特征、干预措施、研究结局指标的相关信息,以及用于我们综述的结局指标数据,以及有关研究设计和方法的信息。由一位作者对符合纳入标准的试验进行质量评估,并从检索到的试验中提取数据进行最终评估,另一位作者进行核对。
纳入了一项随机临床试验,比较经动脉化疗栓塞术(TACE)+经皮瘤内乙醇注射(PEI)与单纯TACE。纳入了48例肝转移患者;25例接受了PEI干预,23例仅接受了TACE。未报告死亡率数据。该试验报告了1年、2年和3年后的生存数据。在TACE+PEI组中,1年、2年和3年后分别有92%、80%和64%的患者存活;在TACE组中,1年、2年和3年后分别有78.3%、65.2%和47.8%的患者存活。风险比为0.57(95%CI 0.19至1.67)。TACE+PEI组的局部复发率为16%,TACE组为39.1%,相对危险度(RR)为0.41(95%CI 0.15至1.07)。TACE+PEI组68个肿瘤中有45个(66.2%)至少缩小了25%,而TACE组64个肿瘤中有31个(48.4%)至少缩小了25%(RR 2.08;95%CI 1.03至4.2)。作者报告了一些不良事件,但细节很少。
基于一项小型随机试验,可以得出结论,对于肝转移患者,与单纯TACE相比,TACE联合PEI在生存和局部复发方面似乎没有明显益处。联合治疗组的肿瘤坏死面积更大。未报告与干预相关的死亡率或重大并发症。需要更多的试验。