Townsend Amanda, Price Timothy, Karapetis Christos
The Queen Elizabeth Hospital, 28 Woodville Road,, Woodville, SA, Australia, 5011.
Cochrane Database Syst Rev. 2009 Oct 7;2009(4):CD007045. doi: 10.1002/14651858.CD007045.pub2.
Liver metastases are often the dominant site of metastatic disease in colorectal cancer. Selective internal radiation therapy (SIRT) involves embolising radiolabeled spheres (SIR-Spheres) into the arterial supply of the liver with the aim of improving the control of liver metastases.
To assess the effectiveness and toxicity of SIRT in the treatment of metastatic colorectal cancer liver metastasis when given alone or with systemic or regional hepatic artery chemotherapy.
We searched the Cochrane Central Register of Controlled Trials (CENTRAL), Cochrane library 2008 issue 2, MEDLINE (1966 to October 2008), EMBASE (1980 to October 2008), and Pubmed (October 2008). The proceedings of ASCO (1985 to 2008) and ASCO GI (2004 to 2008) were also searched. The manufacturers of SIR-Spheres were contacted and asked whether they were aware of any other unpublished studies.
Randomised controlled trials comparing SIRT and chemotherapy (systemic and/or regional) with chemotherapy alone, or comparing SIRT alone with best supportive care in patients with metastatic colorectal cancer.
Two authors (AT/TP) extracted data and assessed the trial quality. The study authors were contacted and individual patient data was obtained. Results were analysed separately for patients with and without extra-hepatic disease.
A single study of 21 patients compared SIRT and systemic chemotherapy (fluorouracil and leucovorin) with chemotherapy alone. There was a significant improvement in progression free survival and median survival associated with SIRT, both for the total studied population and for those disease limited to the liver. There was an increase in toxicity with the use of SIRT. A second study of 63 eligible patients compared SIRT and regional chemotherapy (floxuridine) with regional chemotherapy alone. There was no significant difference in progression free survival and median survival seen with SIRT, in either the total patient group or in the 22 patients with disease limited to the liver. There was no significant increase in toxicity with the addition of SIRT to regional chemotherapy. There were no randomised studies comparing SIRT with best supportive care in patients with refractory disease, and no randomised studies assessing the effect of SIRT in patients with resectable liver metastases.
AUTHORS' CONCLUSIONS: There is a need for well designed, adequately powered phase III trials assessing the effect of SIRT when used with modern combination chemotherapy regimens. Further studies are also needed for patients with refractory disease with a particular focus on the impact on quality of life.
肝转移瘤常是结直肠癌转移疾病的主要部位。选择性体内放射治疗（SIRT）是将放射性标记微球（SIR微球）栓塞至肝脏动脉供血处，目的是改善对肝转移瘤的控制。
评估单独使用SIRT或联合全身或局部肝动脉化疗治疗转移性结直肠癌肝转移的有效性和毒性。
我们检索了Cochrane对照试验中心注册库（CENTRAL）、2008年第2期Cochrane图书馆、MEDLINE（1966年至2008年10月）、EMBASE（1980年至2008年10月）和Pubmed（2008年10月）。还检索了美国临床肿瘤学会（ASCO，1985年至2008年）和ASCO胃肠肿瘤研讨会（ASCO GI，2004年至2008年）的会议记录。联系了SIR微球的制造商，询问他们是否知晓任何其他未发表的研究。
比较SIRT与化疗（全身和/或局部）联合单独化疗，或比较转移性结直肠癌患者单独使用SIRT与最佳支持治疗的随机对照试验。
两名作者（AT/TP）提取数据并评估试验质量。联系了研究作者并获取了个体患者数据。对有或无肝外疾病的患者分别分析结果。
一项纳入21例患者的研究比较了SIRT与全身化疗（氟尿嘧啶和亚叶酸钙）联合单独化疗的情况。对于整个研究人群以及那些疾病局限于肝脏的患者，SIRT在无进展生存期和中位生存期方面均有显著改善。使用SIRT会增加毒性。另一项纳入63例符合条件患者的研究比较了SIRT与局部化疗（氟尿苷）联合单独局部化疗的情况。在整个患者组或22例疾病局限于肝脏的患者中，SIRT在无进展生存期和中位生存期方面均无显著差异。在局部化疗中添加SIRT后毒性没有显著增加。没有随机研究比较SIRT与难治性疾病患者的最佳支持治疗，也没有随机研究评估SIRT对可切除肝转移瘤患者的疗效。
需要设计良好、样本量充足的III期试验来评估SIRT与现代联合化疗方案联合使用时的效果。对于难治性疾病患者也需要进一步研究，特别关注对生活质量的影响。
