BMC Cancer 2005, 5:132 http://www.biomedcentral.com/1471-2407/5/132 treatment administered by a single interventional radiologist. Following a single treatment of SIR-spheres, two weeks after the MAA scan, patients were routinely followed and assessed at monthly intervals. Acute toxicity was assessed initially and at subsequent clinical visits. All toxicities were graded according to National Cancer Institute (NCI) Common Toxicity Criteria, and performance status according to Eastern Cooperative Oncology Group (ECOG) criteria. Disease evaluation was performed by CT imaging at 2 months and bi-monthly thereafter until dis- ease progression. A complete response (CR) was defined as the disappearance of all target lesions. A partial response (PR) was defined as >30 percent decrease in the sum of the longest dimension of the target lesions at 2 months. All responses were confirmed on repeat imaging. Progressive disease (PD) was defined as a >20 percent increase in the sum of the longest recorded target lesion(s) within the liver or the development of new or progressive extrahepatic disease. Stable disease (SD) was defined as a decrease not sufficient to qualify for a PR nor an increase not sufficient to qualify for PD. The results of all staging investigations and toxicity assessments were collected and analysed prospectively. The duration of response was determined from the date of the first response evaluation at 2 months until progressive disease. Results Patient characteristics A total of 30 patients underwent treatment between Janu- ary 2002 and March 2004.(see table 1). There were 22 males and 8 females with a median age of 61.7 years (range 36–77). Ninety percent of patients had an ECOG performance status of 0 or 1. Twenty percent of patients (6) had low-volume extra-hepatic disease, the remainder of the patients had liver-only disease. All patients had failed 5FU chemotherapy and 22 (73%) patients had failed either oxaliplatin or irinotecan containing regi- mens, with 14 (46%) having progressed through both. 21 of the 30 patients received 5-FU concurrent with the SIR- spheres. Of the 30 patients treated, 29 are evaluable for disease response. One patient presented shortly after treatment with worsening liver function tests, liver failure and death considered by the investigator to likely be from rapid dis- ease progression. This was not confirmed with imaging. Overall, there were 10 partial responses (33% of all 30 patients treated). Of note ongoing responses were seen in a number of patients, with continued reduction in the size of liver lesions occurring out to 12 months from treat- ment. One patient with an initial partial response had achieved a complete response at six months. The median duration of response is 8.3 months (range between 2–18+ Table 1: Patient Characteristics Total Number Male Female ECOG 0 ECOG 1 ECOG 2 Extra-hepatic disease Failed 5FU alone Failed 5FU + CPT-11 and Oxaliplatin Failed 5FU + either CPT-11 or Oxaliplatin 30 22 (73%) 8 (27%) 16 (53%) 11 (37%) 3 (10%) 7 (20%) 8 (27%) 14 (46%) 8 (27%) months) at a median follow up time (as of July 2004) of 18.3 months for all patients. Eight patients in total had stable disease at 2 months (27%) and the remaining 12 (40%) had disease progression (n = 11) or were not eval- uable (n = 1). The median time to progression for all patients was 5.3 mths, however, patients who achieved a partial response within the liver as a group had a median progression free survival of 9.2 mths. See table 2 All responses occurred in patients with disease confined to the liver (n = 24) and no responses were seen in patients with a performance status of 2 (n = 3). In the 8 patients that had received only prior 5-FU there were 6 responses (75%). In the patients that had received oxaliplatin and/ or irinotecan (n = 22) there were 5 responses (23%). This included responses in 3 of 14 (21%) patients that had pre- viously received all standard chemotherapy options. No other factors were apparently predictive of response, including the bulk of disease, in this study. Toxicity Overall toxicity assessments were carried out according to NCI common toxicity criteria at all three centres. The find- ings were consistent across all study sites with between 2– 8 weeks of lethargy, anorexia, nausea and RUQ pain being observed to a variable extent in most patients. However, in most cases, these side effects were mild and self-limit- ing following treatment with standard anti-emetics and analgesics medication. Three patients reported severe nau- sea and lethargy for 2 weeks following treatment and moderate symptoms were reported in several patients up to 1 month following treatment. Serious treatment related toxicities clearly related to treat- ment with SIR-spheres were recorded in 4 patients (13%) who had gastric/duodenal ulceration confirmed on gas- troscopy. In 3 of these patients, SIR-spheres were seen in biopsies taken from ulcerated mucosa (Figure 3) and in two patients there was rapid improvement following treatment with proton pump inhibitors. However, one patient had severe ongoing and disabling pain, anorexia Page 3 of 6 (page number not for citation purposes)