BMC Cancer Research article A prospective evaluation of treatment with Selective Internal Radiation Therapy (SIR-spheres) in patients with unresectable liver metastases from colorectal cancer previously treated with 5-FU based chemotherapy L Lim*1, P Gibbs1, D Yip3, JD Shapiro2, R Dowling1, D Smith3, A Little2, W Bailey2 and M Liechtenstein1 BioMed Central Open Access Address: 1The Royal Melbourne Hospital, Parkville, Victoria, Australia, 2Cabrini Hospital Malvern, Victoria, Australia and 3The Canberra Hospital, Canberra, ACT, Australia Email: L Lim* - lionellim@optusnet.com.au; P Gibbs - Peter.Gibbs@mh.org.au; D Yip - dyip@med.usyd.edu.au; JD Shapiro - Jeremy.Shapiro@med.monash.edu.au; R Dowling - Rick.Dowling@mh.org.au; D Smith - dsmith1@gmp.usyd.edu.au; A Little - AFLittle@bigpond.net.au; W Bailey - bailey.thomson@xtra.co.nz; M Liechtenstein - Meir.Lichtenstein@mh.org.au * Corresponding author Published: 15 October 2005 BMC Cancer 2005, 5:132 doi:10.1186/1471-2407-5-132 This article is available from: http://www.biomedcentral.com/1471-2407/5/132 Received: 04 February 2005 Accepted: 15 October 2005 © 2005 Lim et al; licensee BioMed Central Ltd. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Abstract Background: To prospectively evaluate the efficacy and safety of selective internal radiation (SIR) spheres in patients with inoperable liver metastases from colorectal cancer who have failed 5FU based chemotherapy. Methods: Patients were prospectively enrolled at three Australian centres. All patients had previously received 5-FU based chemotherapy for metastatic colorectal cancer. Patients were ECOG 0–2 and had liver dominant or liver only disease. Concurrent 5-FU was given at investigator discretion. Results: Thirty patients were treated between January 2002 and March 2004. As of July 2004 the median follow-up is 18.3 months. Median patient age was 61.7 years (range 36 – 77). Twenty-nine patients are evaluable for toxicity and response. There were 10 partial responses (33%), with the median duration of response being 8.3 months (range 2–18) and median time to progression of 5.3 mths. Response rates were lower (21%) and progression free survival shorter (3.9 mths) in patients that had received all standard chemotherapy options (n = 14). No responses were seen in patients with a poor performance status (n = 3) or extrahepatic disease (n = 6). Overall treatment related toxicity was acceptable, however significant late toxicity included 4 cases of gastric ulceration. Conclusion: In patients with metastatic colorectal cancer that have previously received treatment with 5-FU based chemotherapy, treatment with SIR-spheres has demonstrated encouraging activity. Further studies are required to better define the subsets of patients most likely to respond. Background Colorectal cancer (CRC) is the most common GI malig- nancy accounting for 4718 deaths in Australia [1] and almost 437,000 deaths worldwide annually making it the Page 1 of 6 (page number not for citation purposes)