BMC Cancer 2005, 5:132 http://www.biomedcentral.com/1471-2407/5/132 Table 2: Results At 2 months by patient group (*1 patient died prior to the first evaluation and has been classified as progressive disease). Partial Response (%) Stable Disease (%) Progressive Disease (%) Overall (n = 30) Failed 5FU alone (n = 8) Failed 5FU and CPT-11 and Oxal (n = 14) containing regimens Failed 5FU and either CPT-11 or Oxaliplatin (n = 8) containing regimens Extra-Hepatic disease (n = 7) ECOG 2 (n = 3) 10 (33%) 6 3 2 0 0 8 (27%) 1 2 2 2 1 12 (40%)* 1* 8 4 5 2 and nausea that continued until the time of death 3 months later and another patient experienced ongoing symptoms beyond 3 months, despite the use of proton pump inhibitors. Other serious toxicity potentially related to SIR-spheres included a single patient who was admitted to hospital with acute right upper quadrant pain and marked deterio- ration in her liver function tests one month following treatment with SIR-spheres. The clinical assessment was that the patient likely had radiation hepatitis. Her symp- toms settled with conservative management. Discussion This prospective evaluation documents the experience in our three institutions of using Selective Internal Radiation spheres to treat liver metastases from colorectal cancer in patients that had previously received 5-FU chemotherapy. Our series adds to the published experience documenting the activity of this treatment in selected patients, along with the potential for significant toxicity. For the period of this study oxaliplatin and irinotecan were available in Australia only for patients that had progressed following initial 5-FU based treatment and this is reflected in the study design. Overall in our experience, treatment with SIR-spheres demonstrated promising activity in pre-treated patients with liver metastases from colorectal cancer. Partial responses were seen in six of the eight patients that had failed 5FU alone. This includes one patient that was able to undergo potentially curative resection of residual liver disease after further response to systemic chemotherapy and she remains disease free 22 months later. The response rate in our series is similar to that reported in the previous small randomized study where this combination was used first-line [7]. The progression free and overall survival data for our study are shown in Figure 3. Due to the small patients numbers this activity may partly reflect chance or patient selection. However, this is encouraging efficacy as the alternative treatment for these patients would have been irinotecan alone or oxaliplatin plus 5- fBFrioogmpusryseeov3fegralstSrIiRc mspuhceorseas,schloeawrilnygvinsifblalemmation (gastritis) Biopsy of gastric mucosa showing inflammation (gastritis) from several SIR spheres, clearly visible. FU where responses are typically seen in less than 20% of patients [10,11]. Significant response rates were also seen in patients that had progressed through several lines of chemotherapy. Notably, fourteen of these patients had previously received both irinotecan and oxaliplatin, and the response rate was maintained in this group. The only treatment other option open to these patients would be cetuximab, a monoclonal antibody directed at the epidermal growth factor receptor (EGFR). As a single agent responses are seen in about 10% of patients [12] and response rates are higher when concurrent irinotecan is administered [12]. However, not all patients are suitable for cetuximab as approximately 25% of patients do not express the EGFR[13]. Based on our results SIR-spheres appear to be a good option for patients with colorectal cancer who have liver only disease and maintain a good performance status following progression on all standard chemotherapy Page 4 of 6 (page number not for citation purposes)